+---+-------+-------+----------------+---------------------------------+
| # | *     | **Pr  | **URL**        | **Claim**                       |
|   | *Comp | oduct |                |                                 |
| N | any** | (s)** |                |                                 |
| o |       |       |                |                                 |
+===+=======+=======+================+=================================+
| 1 | ABB   | A     | [www.a         | Layered on to and designed to   |
| . |       | dvant | bb.com](http:/ | be integrated into the hardware |
|   |       |       | /www.abb.com/) | packages is the expertise of    |
|   |       |       |                | ABB's Knowledge solutions.      |
|   |       |       |                | Continually evolving to meet    |
|   |       |       |                | the current and emerging        |
|   |       |       |                | standards important to the      |
|   |       |       |                | Pharmaceutical business, such   |
|   |       |       |                | as Electronic Batch Records     |
|   |       |       |                | based on 21 CFR part 11, or     |
|   |       |       |                | Batch Control Systems           |
|   |       |       |                | compatible with ISA S88.01      |
|   |       |       |                | standards, ABB prides itself in |
|   |       |       |                | providing the customer the      |
|   |       |       |                | optimized package solution for  |
|   |       |       |                | his current and future needs.   |
+---+-------+-------+----------------+---------------------------------+
| 2 | Agile | Agile | [www           | Agile Software Corporation      |
| . | Sof   | Anyw  | .agilesoft.com | provides collaborative          |
|   | tware | here™ | ](http://www.a | manufacturing commerce          |
|   | C     |       | gilesoft.com/) | solutions for the e-supply      |
|   | orpor |       |                | chain. The Agile Anywhere™      |
|   | ation |       |                | product suite allows supply     |
|   |       |       |                | chain partners to leverage the  |
|   |       |       |                | Internet and form virtual       |
|   |       |       |                | manufacturing networks for      |
|   |       |       |                | design control, product         |
|   |       |       |                | introduction, manufacture, and  |
|   |       |       |                | change. Agile Buyer™ enables    |
|   |       |       |                | Internet-based demand           |
|   |       |       |                | aggregation, RFQ processes, and |
|   |       |       |                | online procurement of direct    |
|   |       |       |                | (production) materials. Agile   |
|   |       |       |                | Anywhere is 21 CFR Part 11      |
|   |       |       |                | compliant for electronic        |
|   |       |       |                | records and electronic          |
|   |       |       |                | signatures with a proven        |
|   |       |       |                | validation methodology.         |
+---+-------+-------+----------------+---------------------------------+
| 3 | Ag    | C     | [www.          | The system enables users to     |
| . | ilent | hemSt | chem.agilent.c | comply with audit and approval  |
|   | Tec   | ation | om](../www.che | requirements such as 21 CFR     |
|   | hnolo | Plus  | m.agilent.com) | Part 11.                        |
|   | gies, |       |                |                                 |
|   | Inc.  |       |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 4 | A     | A-S   | <h             | A-S Login for Electronic        |
| . | itken | Login | ttp://www.aitk | Signature Compliance is a       |
|   | Scien |       | en-sci.co.uk/> | software product which provides |
|   | tific |       |                | complete 21 CFR Part 11         |
|   | Ltd.  |       |                | compliant user login functions, |
|   |       |       |                | and a comprehensive             |
|   |       |       |                | administrator console           |
+---+-------+-------+----------------+---------------------------------+
| 5 | Alche | M     | [http://www.a  | DALLAS, TEXAS --- January 9,    |
| . | media | irage | lchemedia.com] | 2002 --- Alchemedia             |
|   | Tec   |       | (http://www.al | Technologies, Inc., a leading   |
|   | hnolo |       | chemedia.com/) | provider of Enterprise Digital  |
|   | gies, |       |                | Rights Management (EDRM)        |
|   | Inc.  |       |                | software, today announced the   |
|   |       |       |                | availability of Mirage          |
|   |       |       |                | Enterprise for pharmaceuticals, |
|   |       |       |                | providing critical data         |
|   |       |       |                | currency and confidentiality    |
|   |       |       |                | functions for companies         |
|   |       |       |                | governed by FDA regulation 21   |
|   |       |       |                | CFR Part 11. Electronic         |
|   |       |       |                | documents, the subject of Part  |
|   |       |       |                | 11, are easy to copy and        |
|   |       |       |                | distribute, but copies are      |
|   |       |       |                | difficult to manage. The        |
|   |       |       |                | resulting rogue documents       |
|   |       |       |                | cannot be audited or updated,   |
|   |       |       |                | and therefore are violations to |
|   |       |       |                | the FDA regulation. By          |
|   |       |       |                | controlling the saving,         |
|   |       |       |                | copying, forwarding and         |
|   |       |       |                | printing of documents, Mirage   |
|   |       |       |                | enables pharmaceutical          |
|   |       |       |                | companies, for the first time,  |
|   |       |       |                | to cut off rogue documents at   |
|   |       |       |                | the source, greatly reducing    |
|   |       |       |                | the scope of their exposure     |
|   |       |       |                | under Part 11.                  |
+---+-------+-------+----------------+---------------------------------+
| 6 | Ame   | UN    | [http://biop   | UNICORN Control System, version |
| . | rsham | ICORN | rocess.apbiote | 4.0, is fully compliant with 21 |
|   | B     | Co    | ch.com/](../ww | CFR Part 11. It is currently in |
|   | iosci | ntrol | w.bioprocess.a | use in many biopharmaceutical   |
|   | ences | Sy    | pbiotech.com/) | production processes approved   |
|   |       | stem, |                | by the FDA.                     |
|   |       | ve    |                |                                 |
|   |       | rsion |                |                                 |
|   |       | 4.0   |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 7 | A     | E     | [http://www.an | Aside from merely understanding |
| . | nalex | Sign | alex.com/html/ | the 21 CFR Part 11 regulation,  |
|   |       |       | med_erecords_e | Analex has successfully         |
|   |       |       | signatures.htm | developed Electronic Records    |
|   |       |       | l](../www.anal | and Electronic Signatures       |
|   |       |       | ex.com/html/me | components, known as ESign™,    |
|   |       |       | d_erecords_esi | for its own in-house software.  |
|   |       |       | gnatures.html) | Analex has also been invited to |
|   |       |       |                | give presentations regarding    |
|   |       |       |                | Part 11 at medical device and   |
|   |       |       |                | pharmaceutical conferences.     |
|   |       |       |                | Using our experience and        |
|   |       |       |                | expertise, Analex can help your |
|   |       |       |                | company become compliant as     |
|   |       |       |                | well.                           |
+---+-------+-------+----------------+---------------------------------+
| 8 | Anke  | TOC   | [http://www    | TOC Talk, Version 3.5 is        |
| . | rsmid | Talk, | .ankersmid.com | designed to handle and manage   |
|   |       | Ve    | /Holland/index | TOC data and metadata within    |
|   |       | rsion | hollan         | the TOC Talk application in     |
|   |       | 3.5   | d.htm](../www. | compliance with 21 CFR Part 11  |
|   |       |       | ankersmid.com/ | protocols                       |
|   |       |       | Holland/index% |                                 |
|   |       |       | 20holland.htm) |                                 |
+---+-------+-------+----------------+---------------------------------+
| 9 | Ap    | Ana   | [              | Analyst™ software unites power  |
| . | plied | lyst™ | www.appliedbio | and ease to set a new standard  |
|   | Biosy |       | systems.com]() | in Windows NT® platform-based   |
|   | stems | SQL   |                | data processing. Automated      |
|   |       | LIMS  |                | software routines rapidly and   |
|   |       |       |                | completely optimize the         |
|   |       |       |                | instrument for quantitative     |
|   |       |       |                | analysis. After data            |
|   |       |       |                | acquisition, the Quantitation   |
|   |       |       |                | Wizard quickly guides the       |
|   |       |       |                | creation of new quantitation    |
|   |       |       |                | methods. Queries, metric plots, |
|   |       |       |                | configurable results table, and |
|   |       |       |                | slide show mode provide fast    |
|   |       |       |                | and thorough data review. For   |
|   |       |       |                | regulated laboratories, you can |
|   |       |       |                | easily achieve GLP compliance   |
|   |       |       |                | including the recommendations   |
|   |       |       |                | of 21 CFR Part 11 with          |
|   |       |       |                | comprehensive Security and      |
|   |       |       |                | centralized Audit Trail         |
|   |       |       |                | Manager. Analyst software       |
|   |       |       |                | provides flexible data          |
|   |       |       |                | acquisition, fast and easy      |
|   |       |       |                | data. SQL\*LIMS® software is a  |
|   |       |       |                | complete laboratory information |
|   |       |       |                | management system (LIMS) that   |
|   |       |       |                | gives you control over sample   |
|   |       |       |                | tracking, laboratory processes  |
|   |       |       |                | and workflow, data access and   |
|   |       |       |                | storage, and regulatory         |
|   |       |       |                | compliance. Supports your       |
|   |       |       |                | laboratory's compliance with    |
|   |       |       |                | the FDA's 21 CFR 11 Rule with   |
|   |       |       |                | dynamic security and regulatory |
|   |       |       |                | compliance features             |
+---+-------+-------+----------------+---------------------------------+
| 1 | Ap    | Ap    | [www.          | ASI offers the most             |
| 0 | plied | plied | appliedstatist | comprehensive tools available   |
| . | Stati | Stats | ics.com/press/ | today to address the security   |
|   | stics | v4.4  | 21CFR.htm](../ | and data collection             |
|   | Inc.  | SPC   | www.appliedsta | requirements posed by 21 CFR    |
|   |       |       | tistics.com/pr | Part 11. Applied Stats v4.4 SPC |
|   |       |       | ess/21CFR.htm) | software package incorporates a |
|   |       |       |                | robust set of security options  |
|   |       |       |                | and policies that allow our     |
|   |       |       |                | customers to comply with these  |
|   |       |       |                | rigorous requirements and       |
|   |       |       |                | collect data with confidence.   |
+---+-------+-------+----------------+---------------------------------+
| 1 | ARC   | T     | <http://www.ac | ACR Systems Inc. has introduced |
| 1 | Sys   | rendR | rsystems.com/> | a new update version of the     |
| . | tems, | eader |                | TrendReader Standard Data       |
|   | Inc.  | Sta   |                | Logger Software, version 1.2    |
|   |       | ndard |                | beta, which includes data       |
|   |       | Data  |                | validation that permits our     |
|   |       | L     |                | software and hardware to        |
|   |       | ogger |                | conform to the FDA's 21 CFR     |
|   |       |       |                | Part 11 regulations. This       |
|   |       |       |                | assures users that the data     |
|   |       |       |                | viewed on either the PC or      |
|   |       |       |                | printed form is authentic by    |
|   |       |       |                | providing a data file sign-off  |
|   |       |       |                | mechanism, a CRC check (Cyclic  |
|   |       |       |                | Redundancy Check) for data      |
|   |       |       |                | integrity, and an overall data  |
|   |       |       |                | validation pass/fail statement  |
|   |       |       |                | with sign-off right on the      |
|   |       |       |                | graph.                          |
+---+-------+-------+----------------+---------------------------------+
| 1 | Aspen | In    | http://www.    | Aspen Technology Inc. announced |
| 2 | Tech  | foPlu | aspentech.com/ | new software solutions that     |
| . |       | s.21 |                | provide pharmaceutical and      |
|   |       | and   |                | other regulated process         |
|   |       | Batch |                | manufacturers with a broad      |
|   |       | .21; |                | range of solutions to comply    |
|   |       | Aspen |                | with Title 21 of the Code of    |
|   |       | Alarm |                | Federal Regulations.            |
|   |       | and   |                |                                 |
|   |       | Ev    |                |                                 |
|   |       | ent; |                |                                 |
|   |       | Aspen |                |                                 |
|   |       | eBRS |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | A     | CA    | [www.assurx.   | Are you concerned about Title   |
| 3 | ssurX | TSWeb | com](http://ww | 21 CFR Part 11 FDA regulations  |
| . |       |       | w.assurx.com/) | governing electronic records    |
|   |       |       |                | and electronic signatures?      |
|   |       |       |                | Don\'t be. The FDA edition of   |
|   |       |       |                | CATSWeb is fully compliant.     |
+---+-------+-------+----------------+---------------------------------+
| 1 | Auto  | Ra    | [www           | Automsoft\'s RAPID-Pharma is    |
| 4 | msoft | pid-P | .automsoft.com | the first Plant Information     |
| . | Int   | harma | ](http://www.a | Management System to offer out  |
|   | ernat |       | utomsoft.com/) | of the box compliance with the  |
|   | ional |       |                | specification, which will       |
|   | LTD   |       |                | enable companies to keep        |
|   |       |       |                | complete audit trails of their  |
|   |       |       |                | electronic records in a highly  |
|   |       |       |                | secure system.                  |
+---+-------+-------+----------------+---------------------------------+
| 1 | A     | LAB   | [w             | LABTrack incorporates a         |
| 5 | VATAR | Track | ww.labtrack.co | function called Electronic      |
| . | Consu |       | m](http://www. | Signature that was defined by   |
|   | lting |       | labtrack.com/) | the United States Food & Drug   |
|   |       |       |                | Administration (21 CFR Part     |
|   |       |       |                | 11). Electronic Signature is a  |
|   |       |       |                | mechanism to accurately         |
|   |       |       |                | identify the user of the        |
|   |       |       |                | software at the time data is    |
|   |       |       |                | saved. It can do so using       |
|   |       |       |                | either controlled passwords or  |
|   |       |       |                | biometric devices like          |
|   |       |       |                | fingerprint readers. LABTrack   |
|   |       |       |                | supports both.                  |
+---+-------+-------+----------------+---------------------------------+
| 1 | B     | QM6,  | [http://www.be | The Log Book option now also    |
| 6 | eamex | Qu    | amex.com/produ | includes an Electronic          |
| . |       | ality | cts/qm6_004.ht | Signature feature. If the       |
|   |       | Ma    | m](../www.beam | Electronic Signature is         |
|   |       | nager | ex.com/product | enabled, QM6 prompts for user   |
|   |       | C     | s/qm6_004.htm) | id and password when a          |
|   |       | alibr |                | calibration is saved or         |
|   |       | ation |                | approved.                       |
|   |       | Sof   |                |                                 |
|   |       | tware |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | Be    | Pin   | [              | Pinnacle is the first CDS to be |
| 7 | ckman | nacle | www.beckmancou | designed from the ground up to  |
| . | Co    |       | lter.com/pinna | meet Part 11 requirements. Its  |
|   | ulter |       | clepart11](htt | Oracle\* relational database    |
|   |       |       | p://www.beckma | and built-in security system    |
|   |       |       | ncoulter.com/p | ensure that no data can be      |
|   |       |       | innaclepart11) | deleted and that modifications  |
|   |       |       |                | are only performed by           |
|   |       |       |                | authorized personnel. Not only  |
|   |       |       |                | do Pinnacle\'s electronic       |
|   |       |       |                | records meet Part 11            |
|   |       |       |                | requirements, system            |
|   |       |       |                | administrators can also         |
|   |       |       |                | minimize the compliance burden  |
|   |       |       |                | by determining when electronic  |
|   |       |       |                | signatures and modification     |
|   |       |       |                | reasons are required.           |
+---+-------+-------+----------------+---------------------------------+
| 1 | B     | Mic   | [http          | The MicroLog and OmniLog        |
| 8 | ioLog | roLog | ://www.biolog. | systems are designed to exist   |
| . |       | and   | com](http://ww | within a 21CFR Part 11          |
|   |       | Om    | w.biolog.com/) | environment and provide the     |
|   |       | niLog |                | basic functionality to support  |
|   |       | Sy    |                | our customer\'s compliance      |
|   |       | stems |                | efforts. Biolog provides all of |
|   |       |       |                | the necessary software          |
|   |       |       |                | features, validation packages,  |
|   |       |       |                | and optional assistance to      |
|   |       |       |                | support full (including 21 CFR  |
|   |       |       |                | Part 11) compliance.            |
+---+-------+-------+----------------+---------------------------------+
| 1 | BioM  | INDe  | [http://www.   | INDexxis™ is designed to manage |
| 9 | edion | xxis™ | biomedion.com/ | data in accordance with         |
| . |       |       | en/indexxis.ht | predicate rules (GxP) and the   |
|   |       |       | ml](../www.bio | new regulations on electronic   |
|   |       |       | medion.com/en/ | records and electronic          |
|   |       |       | indexxis.html) | signatures, especially FDA      |
|   |       |       |                | 21CFRpart11.                    |
+---+-------+-------+----------------+---------------------------------+
| 2 | Blaze | Blaz  | [www.          | BlazeLIMS Enterprise Plus       |
| 0 | Sy    | eLIMS | blazesystems.c | provides flexible sample        |
| . | stems | Enter | om](../www.bla | registration functions,         |
|   | Corp. | prise | zesystems.com) | including ad hoc logs,          |
|   |       | Plus  |                | batch/requests, QC batch, and   |
|   |       |       |                | stability studies, with manual  |
|   |       |       |                | or automated results entry in a |
|   |       |       |                | 21 CFR Part 11-compliant        |
|   |       |       |                | environment.                    |
+---+-------+-------+----------------+---------------------------------+
| 2 | Blue  | C     | [w             | Our flagship product,           |
| 1 | Mou   | alibr | ww.coolblue.co | Calibration Manager® software,  |
| . | ntain | ation | m](http://www. | is among the world\'s leading   |
|   | Sof   | Man   | coolblue.com/) | calibration management database |
|   | tware | ager® |                | programs. Calibration Manager   |
|   |       |       |                | automatically calculates due    |
|   |       |       |                | dates, tracks histories and     |
|   |       |       |                | prints reports of calibration   |
|   |       |       |                | schedules. It also tracks       |
|   |       |       |                | preventive maintenance.         |
|   |       |       |                | Flexible data retrieval and     |
|   |       |       |                | reporting capabilities permit   |
|   |       |       |                | customization according to your |
|   |       |       |                | exact needs. Password           |
|   |       |       |                | protection, audit trail and     |
|   |       |       |                | electronic signature features   |
|   |       |       |                | facilitate your validation      |
|   |       |       |                | process and ensure effective    |
|   |       |       |                | FDA record-keeping compliance.  |
|   |       |       |                | The electronic signature        |
|   |       |       |                | functionality was specifically  |
|   |       |       |                | designed to meet FDA 21CFR Part |
|   |       |       |                | 11 requirements.                |
+---+-------+-------+----------------+---------------------------------+
| 2 | Br    | St    | <http://www    | Brendan develops laboratory     |
| 2 | endan | atLIA | .brendan.com/> | software to provide one         |
| . | Scien |       |                | complete standardized program   |
|   | tific |       |                | for all immunoassay testing     |
|   |       |       |                | technologies. For automating    |
|   |       |       |                | workflow, the software is       |
|   |       |       |                | designed for easy interfacing   |
|   |       |       |                | and networking to any LIM       |
|   |       |       |                | system, instrument and PC. And  |
|   |       |       |                | all raw, computed and           |
|   |       |       |                | statistically analyzed data are |
|   |       |       |                | organized, secured, and easily  |
|   |       |       |                | accessible. We believe that the |
|   |       |       |                | less time spent processing,     |
|   |       |       |                | computing, validating,          |
|   |       |       |                | organizing, and troubleshooting |
|   |       |       |                | data, the more time             |
|   |       |       |                | laboratories can spend using    |
|   |       |       |                | the data generated. 21 CFR Part |
|   |       |       |                | 11 Compliant.                   |
+---+-------+-------+----------------+---------------------------------+
| 2 | Ca    | Main  | [http://www.ca | Cayenta\'s state-of-the-art,    |
| 3 | yenta | saver | yenta.com/manu | award-winning, Computerized     |
| . |       | EAM   | facturing/desc | Maintenance Management Software |
|   |       |       | ription.html - | is used by companies both small |
|   |       |       | fda            | and large to minimize operation |
|   |       |       | ](../www.cayen | costs and maximize              |
|   |       |       | ta.com/manufac | productivity. Mainsaver is a    |
|   |       |       | turing/descrip | total solution for Enterprise   |
|   |       |       | tion.html#fda) | Asset Management (EAM).         |
|   |       |       |                | Mainsaver offers a robust       |
|   |       |       |                | Enterprise Asset Management     |
|   |       |       |                | (EAM) solution, professional    |
|   |       |       |                | consulting services,            |
|   |       |       |                | implementation and training     |
|   |       |       |                | services and now compliance to  |
|   |       |       |                | FDA's 21 CFR. 11 so you can     |
|   |       |       |                | maintain your competitive edge. |
+---+-------+-------+----------------+---------------------------------+
| 2 | Ch    | EndoS | [h             | Our EndoScan-V version 1.0.13   |
| 4 | arles | can-V | ttp://www.criv | is the first endotoxin-specific |
| . | River | ve    | er.com/faq/end | software that addresses the 21  |
|   | La    | rsion | otoxin/](../ww | CFR Part 11 requirement for     |
|   | borat | 1     | w.criver.com/f | validation.                     |
|   | ories | .0.13 | aq/endotoxin/) |                                 |
+---+-------+-------+----------------+---------------------------------+
| 2 | Ch    |       | [http:         | **Chemera, inc.** has developed |
| 5 | emera |       | //www.chemera. | proprietary software utilizing  |
| . | Inc.  |       | com/chemera/en | 128-bit encryption technology   |
|   |       |       | cryption.asp]( | that fully complies with 21 CFR |
|   |       |       | ../www.chemera | part 11 (FDA regulation).       |
|   |       |       | .com/chemera/e |                                 |
|   |       |       | ncryption.asp) |                                 |
+---+-------+-------+----------------+---------------------------------+
| 2 | Chem  | eGMP  | [www.egm       | eGMP is compliant with FDA      |
| 6 | Scope |       | p.com](http:// | regulations, including 21 CFR   |
| . |       |       | www.egmp.com/) | Part 11. And all through a      |
|   |       |       |                | single web browser!             |
+---+-------+-------+----------------+---------------------------------+
| 2 | C     | CIS   | [www           | ChemSW announced a new option   |
| 7 | hemSW | Che   | .chemsw.com]() | for its CIS Chemical Inventory  |
| . |       | mical |                | System^®^ that provides audit   |
|   |       | Inve  |                | trail and electronic signature, |
|   |       | ntory |                | for 21 CFR Part 11 compliance.  |
|   |       | Syst  |                | The system incorporates         |
|   |       | em^®^ |                | multiple levels of security,    |
|   |       |       |                | transaction logging and         |
|   |       |       |                | signature verification. Ideal   |
|   |       |       |                | for use in pharmaceutical       |
|   |       |       |                | laboratory applications, the    |
|   |       |       |                | new security and audit trail    |
|   |       |       |                | option allows the system        |
|   |       |       |                | administrator to determine      |
|   |       |       |                | which users are authorized to   |
|   |       |       |                | make various kinds of changes,  |
|   |       |       |                | and enables accurate tracking   |
|   |       |       |                | of all change sources.          |
+---+-------+-------+----------------+---------------------------------+
| 2 | C     | No    | [http://ww     | Cimage NovaSoft, a global       |
| 8 | image | vaGMP | w.cimagenovaso | provider of eBusiness           |
| . | Nov   |       | ft.com/news/ne | application solutions to        |
|   | asoft |       | wsreleases/prg | industry, today announced the   |
|   |       |       | mp0601.htm](.. | release of NovaGMP. This        |
|   |       |       | /www.cimagenov | product helps FDA regulated     |
|   |       |       | asoft.com/news | companies, such as              |
|   |       |       | /newsreleases/ | pharmaceutical and medical      |
|   |       |       | prgmp0601.htm) | device manufacturers, to comply |
|   |       |       |                | with the FDA regulation 21 CFR  |
|   |       |       |                | Part 11 for electronic records  |
|   |       |       |                | and signatures. NovaGMP is part |
|   |       |       |                | of the Cimage NovaSoft GMP      |
|   |       |       |                | suite, which is based upon      |
|   |       |       |                | Cimage NovaSoft\'s extensive    |
|   |       |       |                | pharmaceutical manufacturing    |
|   |       |       |                | and medical device industry     |
|   |       |       |                | experience. It enables FDA      |
|   |       |       |                | regulated companies to manage   |
|   |       |       |                | laboratory and processing       |
|   |       |       |                | information throughout its      |
|   |       |       |                | lifecycle, helping them to      |
|   |       |       |                | achieve the documentation,      |
|   |       |       |                | safety and quality standards    |
|   |       |       |                | required to comply with Current |
|   |       |       |                | Good Manufacturing Practices    |
|   |       |       |                | (cGMP).                         |
+---+-------+-------+----------------+---------------------------------+
| 2 | C     | eInf  | [www.part11    | Designed specifically to meet   |
| 9 | imcon | oTree | solutions.com] | the regulatory requirements of  |
| . | Soft  | ™     | (../www.part11 | the life science industries,    |
|   | ware, |       | solutions.com) | the eInfotreeTM Digital         |
|   | Inc.  |       |                | Compliance solution replaces    |
|   |       |       |                | traditional paper-based         |
|   |       |       |                | regulatory data and processes   |
|   |       |       |                | and is fully compliant with 21  |
|   |       |       |                | CFR Part 11 requirements for    |
|   |       |       |                | Electronic Records and          |
|   |       |       |                | Electronic Signatures.          |
|   |       |       |                | eInfotree's patent-pending      |
|   |       |       |                | Digital ComplianceTM            |
|   |       |       |                | Architecture seamlessly         |
|   |       |       |                | integrates disparate \"islands  |
|   |       |       |                | of information\" without        |
|   |       |       |                | affecting existing business     |
|   |       |       |                | processes into a regulated,     |
|   |       |       |                | controlled and compliant        |
|   |       |       |                | digital nervous system with     |
|   |       |       |                | single point access throughout  |
|   |       |       |                | the workgroup, department or    |
|   |       |       |                | enterprise.                     |
+---+-------+-------+----------------+---------------------------------+
| 3 | CIMT  | CIM   | <ht            | The FDA has now started         |
| 0 | echni | Scan | tp://www.cimte | aggressive enforcement of 21    |
| . | ques, |       | chniques.com/> | CFR Part 11, which is the       |
|   | Inc.  |       |                | regulation regarding electronic |
|   |       |       |                | records and electronic          |
|   |       |       |                | signatures. CIMScan now         |
|   |       |       |                | contains all the necessary      |
|   |       |       |                | functions and capabilities to   |
|   |       |       |                | insure compliance.              |
+---+-------+-------+----------------+---------------------------------+
| 3 | C     | Si    | [http://ww     | Conclusion:                     |
| 1 | lient | lvers | w.clients.ie/c |                                 |
| . | Solu  | tream | asestudies/jan | The system was implemented      |
|   | tions | V2.5  | ssen.shtml](.. | within spec, within budget and  |
|   |       |       | /www.clients.i | on-time.                        |
|   |       |       | e/casestudies/ |                                 |
|   |       |       | janssen.shtml) | Change requests are now being   |
|   |       |       |                | processed more efficiently and  |
|   |       |       |                | with greater speed.             |
|   |       |       |                |                                 |
|   |       |       |                | Users know where their request  |
|   |       |       |                | is, what is its status and who  |
|   |       |       |                | is holding it                   |
|   |       |       |                |                                 |
|   |       |       |                | Janssen have successfully       |
|   |       |       |                | removed the paperwork from the  |
|   |       |       |                | change control process          |
|   |       |       |                |                                 |
|   |       |       |                | The system is compliant with    |
|   |       |       |                | FDA regulation 21 part 11       |
|   |       |       |                |                                 |
|   |       |       |                | The system is currently being   |
|   |       |       |                | used by fifty staff members and |
|   |       |       |                | can be deployed further at zero |
|   |       |       |                | cost                            |
|   |       |       |                |                                 |
|   |       |       |                | Because the system is intranet  |
|   |       |       |                | based, changes or ammendments   |
|   |       |       |                | can be made at server level and |
|   |       |       |                | deployed immediately            |
+---+-------+-------+----------------+---------------------------------+
| 3 | Cli   | Clin  | [w             | Clinsoft Corporation is the     |
| 2 | nsoft | trial | ww.clinsoft.co | world\'s largest provider of    |
| . |       | Co    | m](http://www. | clinical research systems.      |
|   |       | nnect | clinsoft.com/) | Market leadership and           |
|   |       | ™     |                | innovative technology position  |
|   |       |       |                | Clintrial™ as the               |
|   |       | Clin  |                | industry-standard information   |
|   |       | trial |                | platform for biopharmaceutical  |
|   |       | ™     |                | and related industries.         |
|   |       |       |                | Clinsoft\'s information         |
|   |       | Clin  |                | platform enables companies to   |
|   |       | trace |                | focus development resources on  |
|   |       | ™     |                | product \"winners\" sooner and  |
|   |       |       |                | has brought more pharmaceutical |
|   |       | Integ |                | products to market than any     |
|   |       | rated |                | other software platform.        |
|   |       | R     |                |                                 |
|   |       | eview |                |                                 |
|   |       | ™     |                |                                 |
|   |       |       |                |                                 |
|   |       | Jr    |                |                                 |
|   |       | eview |                |                                 |
|   |       | ™     |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 3 | ClinS | Tr    | [http://ww     | TrialXS / EDC complies with FDA |
| 3 | ource | ialXS | w.clinsource.c | 21 CFR Part 11 regulation and   |
| . |       | / EDC | om/](../www.cl | conforms to GCP guidelines.     |
|   |       |       | insource.com/) |                                 |
+---+-------+-------+----------------+---------------------------------+
| 3 | C     | In-   | [http://       | Cognex Corporation (NASDAQ -    |
| 4 | ognex | Sight | www.cognex.com | CGNX), the world\'s leading     |
| . |       | ™     | /corporate/n_n | supplier of machine vision      |
|   |       |       | ews-compliance | systems, announced that its     |
|   |       |       | .asp](../www.c | In-Sight ™ family of            |
|   |       |       | ognex.com/corp | networkable vision sensors are  |
|   |       |       | orate/n_news-c | compliant with the U.S. Food    |
|   |       |       | ompliance.asp) | and Drug Administration\'s 21   |
|   |       |       |                | CFR Part 11 regulations. Cognex |
|   |       |       |                | Corporation designs, develops,  |
|   |       |       |                | manufactures, and markets       |
|   |       |       |                | machine vision systems, or      |
|   |       |       |                | computers that can \"see.\" As  |
|   |       |       |                | part of its compliance          |
|   |       |       |                | initiative, the company has     |
|   |       |       |                | authored and published detailed |
|   |       |       |                | Application Guidelines that     |
|   |       |       |                | provide recommendations for     |
|   |       |       |                | developing 21 CFR Part          |
|   |       |       |                | 11-compliant automation         |
|   |       |       |                | projects, which incorporate     |
|   |       |       |                | machine vision technology.      |
+---+-------+-------+----------------+---------------------------------+
| 3 | Com   | Sign  | [ht            | Provide electronic signature    |
| 5 | munic | IT    | tp://www.penop | software. Communication         |
| . | ation |       | .com](http://w | Intelligence Corporation (CIC), |
|   | In    |       | ww.penop.com/) | provides input, security and    |
|   | telli |       |                | electronic signature offerings  |
|   | gence |       |                | to Enterprises, OEMs,           |
|   | C     |       |                | integrators, Asps, Strategic    |
|   | orpor |       |                | Partners and End Users.         |
|   | ation |       |                |                                 |
|   | (CIC) |       |                | And by making possible the      |
|   |       |       |                | legally secure electronic       |
|   |       |       |                | signing of documents anywhere   |
|   |       |       |                | at any time, CIC leadership is  |
|   |       |       |                | a prime mover of businesses     |
|   |       |       |                | toward a paperless world.       |
+---+-------+-------+----------------+---------------------------------+
| 3 | Compl | EM    | [www.c         | Compliance Software Solutions   |
| 6 | iance | SS^©^ | softsol.com]() | Corporation (CSSC) has          |
| . | Sof   |       |                | developed the Environmental     |
|   | tware |       |                | Monitoring Software System      |
|   | Solu  |       |                | (EMSS^©^) to comply with the    |
|   | tions |       |                | requirements defined in the     |
|   | Corp. |       |                | FDA's 21 CFR Part 11 for        |
|   |       |       |                | Electronic Documents            |
+---+-------+-------+----------------+---------------------------------+
| 3 | Com   | EFL   | [http://www    | A revolutionary, powerful       |
| 7 | puter | EXION | .e-flexion.com | monitoring tool, EFLEXION fully |
| . | C     |       | ](http://www.e | automates the tasks of process  |
|   | ompli |       | -flexion.com/) | data management. E-Flexion      |
|   | ance, |       |                | automates every step, every     |
|   | Inc.  |       |                | task, in quality information    |
|   |       |       |                | management. Manual data         |
|   |       |       |                | handling is eliminated, saving  |
|   |       |       |                | considerable time and freeing   |
|   |       |       |                | people for higher level,        |
|   |       |       |                | strategic use. Human time can   |
|   |       |       |                | be spent interpreting results   |
|   |       |       |                | and taking action.              |
|   |       |       |                | Comprehensive in operation,     |
|   |       |       |                | analytical abilities, and       |
|   |       |       |                | features, E-Flexion gathers,    |
|   |       |       |                | analyzes, and delivers all the  |
|   |       |       |                | information you need. Data is   |
|   |       |       |                | collected and analyzed around   |
|   |       |       |                | the clock from any piece of     |
|   |       |       |                | equipment, for any desired      |
|   |       |       |                | analysis. Everything from       |
|   |       |       |                | production data to run comments |
|   |       |       |                | is stored in a complete record. |
|   |       |       |                |                                 |
|   |       |       |                | Built for compliance from the   |
|   |       |       |                | ground up, E-Flexion meets      |
|   |       |       |                | strict federal regulations for  |
|   |       |       |                | electronic record keeping,      |
|   |       |       |                | including requirements of FDA   |
|   |       |       |                | 21CFR Part 11. An internal      |
|   |       |       |                | audit log \-- with assigned     |
|   |       |       |                | access privileges \-- tracks    |
|   |       |       |                | any changes made to any records |
|   |       |       |                | in the database repository.     |
|   |       |       |                | Repository data cannot be       |
|   |       |       |                | deleted. Data transfer from     |
|   |       |       |                | collection to repository is     |
|   |       |       |                | error-free and fault-tolerant.  |
+---+-------+-------+----------------+---------------------------------+
| 3 | Cons  | Cons  | [http:         | ConsenSys MedDev has been       |
| 8 | enSys | enSys | //www.415.com/ | specifically designed to meet   |
| . | Sof   | M     | demos/consensy | the requirements of the Part 11 |
|   | tware | edDev | s/02ourprod/02 | rule, which dictates the        |
|   | C     |       | c.cmdds.html]( | accepted use of electronic      |
|   | orpor |       | ../www.415.com | signatures and electronic       |
|   | ation |       | /demos/consens | records. ConsenSys MedDev       |
|   |       |       | ys/02ourprod/0 | ensures that every release or   |
|   |       |       | 2c.cmdds.html) | revision of a part or document  |
|   |       |       |                | has associated with it one or   |
|   |       |       |                | more reviews or change orders.  |
|   |       |       |                | These work records in turn      |
|   |       |       |                | contain the signatures,         |
|   |       |       |                | comments, and justification     |
|   |       |       |                | records for the release or      |
|   |       |       |                | revision. This web of related   |
|   |       |       |                | records forms a cohesive audit  |
|   |       |       |                | trail that completely addresses |
|   |       |       |                | FDA/ISO requirements.           |
+---+-------+-------+----------------+---------------------------------+
| 3 | Creon | Q-    | [www.creon     | The extended use of computer    |
| 9 |       | DIS/R | .com](http://w | technology and the increasing   |
| . |       |       | ww.creon.com/) | automation in the field of      |
|   |       |       |                | modern chemical analytic,       |
|   |       |       |                | produces large quantities of    |
|   |       |       |                | analytical data.                |
|   |       |       |                |                                 |
|   |       |       |                | In consideration of:            |
|   |       |       |                |                                 |
|   |       |       |                | > • the diversity of data       |
|   |       |       |                | > sources                       |
|   |       |       |                | >                               |
|   |       |       |                | > • GLP and GMP guidelines      |
|   |       |       |                | >                               |
|   |       |       |                | > • governmental requirements   |
|   |       |       |                | > (FDA 21, CFR Part 11)         |
|   |       |       |                | >                               |
|   |       |       |                | > • company objectives          |
+---+-------+-------+----------------+---------------------------------+
| 4 | CRF   | CRF   | [http://www.cr | THE KEY FEATURES OF CRF BOX     |
| 0 | Box   | Box   | fbox.com/3.htm | WIRELESS™ INCLUDE:              |
| . |       | Wire  | l](../www.crfb |                                 |
|   |       | less™ | ox.com/3.html) | Patient-generated data entry    |
|   |       |       |                | via a wireless or handheld      |
|   |       |       |                | device                          |
|   |       |       |                |                                 |
|   |       |       |                | Edit checks to diary data       |
|   |       |       |                | before entry into trial         |
|   |       |       |                | database                        |
|   |       |       |                |                                 |
|   |       |       |                | 2-way communication between     |
|   |       |       |                | clinical R&D stakeholders       |
|   |       |       |                |                                 |
|   |       |       |                | Diary page amendments during    |
|   |       |       |                | the trial conduct               |
|   |       |       |                |                                 |
|   |       |       |                | Multiple languages and          |
|   |       |       |                | technology platforms in the     |
|   |       |       |                | same trial                      |
|   |       |       |                |                                 |
|   |       |       |                | Flexible generation of          |
|   |       |       |                | reminders and alerts to         |
|   |       |       |                | patients, based on the          |
|   |       |       |                | cumulative history in the trial |
|   |       |       |                |                                 |
|   |       |       |                | Interface to the major clinical |
|   |       |       |                | data management systems with    |
|   |       |       |                | industry-standard XML           |
|   |       |       |                |                                 |
|   |       |       |                | High level of security based on |
|   |       |       |                | PKI (Public Key Infrastructure) |
|   |       |       |                | digital signature technology    |
|   |       |       |                |                                 |
|   |       |       |                | 21 CFR Part 11 compliance       |
+---+-------+-------+----------------+---------------------------------+
| 4 | CSE   | CIWOS | [http://www.ci | CSEngineering AG has software   |
| 1 | ngine |       | wos.com/](../w | called CIWOS that is 21 CFR     |
| . | ering |       | ww.ciwos.com/) | Part 11 compliant.              |
|   | AG    |       |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 4 | Cyber | Cyber | [www           | Cyber-SIGN and Biometric        |
| 2 | -SIGN | -SIGN | .cybersign.com | Dynamic Signature Verification  |
| . | Inc.  |       | ](http://www.c |                                 |
|   |       |       | ybersign.com/) | Cyber-SIGN®, we are a leader in |
|   |       |       |                | the area of on-line enterprise  |
|   |       |       |                | user authentication utilizing   |
|   |       |       |                | biometric dynamic signature     |
|   |       |       |                | verification technology. With   |
|   |       |       |                | Cyber-SIGN, using handwritten   |
|   |       |       |                | signatures, on-line identity is |
|   |       |       |                | securely authenticated and a    |
|   |       |       |                | trusted electronic signature is |
|   |       |       |                | created. Our technology is a    |
|   |       |       |                | simple and natural biometric    |
|   |       |       |                | system that increases data      |
|   |       |       |                | security and enables trusted    |
|   |       |       |                | document authorization. We      |
|   |       |       |                | analyze the shape, speed,       |
|   |       |       |                | stroke order, off-tablet        |
|   |       |       |                | motion, pen pressure and timing |
|   |       |       |                | information captured during the |
|   |       |       |                | act of signing. The captured    |
|   |       |       |                | values are unique to an         |
|   |       |       |                | individual and virtually        |
|   |       |       |                | impossible to duplicate.        |
+---+-------+-------+----------------+---------------------------------+
| 4 | Daon  | Dao   | [www.dao       | Biometrically secured           |
| 3 |       | nSign | n.com](http:// | electronic signing capabilities |
| . |       |       | www.daon.com/) | for the Pharmaceutical          |
|   |       |       |                | Industry. Daon\'s e-signature   |
|   |       |       |                | solution adheres to Worldwide   |
|   |       |       |                | Regulations & Legislation       |
|   |       |       |                | around the use of electronic    |
|   |       |       |                | signatures.                     |
+---+-------+-------+----------------+---------------------------------+
| 4 | DataM | Live  | <http://www.da | DataMirror provides real-time   |
| 4 | irror | Audit | tamirror.com/r | data integration software that  |
| . |       |       | esourcecenter> | helps companies ensure          |
|   |       |       |                | cost-effective compliance with  |
|   |       |       |                | FDA Regulation 21-CFR Part 11.  |
|   |       |       |                | LiveAudit™ for DataMirror       |
|   |       |       |                | Transformation Server enables   |
|   |       |       |                | FDA-regulated companies to      |
|   |       |       |                | create real-time audit trails   |
|   |       |       |                | that preserve historical        |
|   |       |       |                | information                     |
+---+-------+-------+----------------+---------------------------------+
| 4 | Data  | Data  | http://www.    | Datasweep, Inc. provides        |
| 5 | Sweep | Sweep | datasweep.com/ | collaborative solutions for the |
| . |       |       |                | medical industry to establish a |
|   |       |       |                | paperless GMP environment that  |
|   |       |       |                | is compliant with 21 CFR Part   |
|   |       |       |                | 11. Datasweep\'s solutions      |
|   |       |       |                | leverage the Internet to give   |
|   |       |       |                | medical OEMs and their partners |
|   |       |       |                | the Web visibility into and     |
|   |       |       |                | control of real-time            |
|   |       |       |                | manufacturing and quality       |
|   |       |       |                | information to drive            |
|   |       |       |                | improvements in planning,       |
|   |       |       |                | manufacturing, record archiving |
|   |       |       |                | and product lifecycle           |
|   |       |       |                | management, while driving down  |
|   |       |       |                | the total cost of compliancy.   |
+---+-------+-------+----------------+---------------------------------+
| 4 | Dat   | Dat   | [              | **CFR21;Part 11 Compliant -**   |
| 6 | aTrak | atrak | http://www.dat | Contact us for a document with  |
| . | Int   | EDC   | atraknet.com]( | details. **Audit Trail:** When  |
|   | ernat |       | http://www.dat | you compare EDC product you\'ll |
|   | ional |       | atraknet.com/) | find DATATRAK\'s Audit Trail to |
|   |       |       |                | be the best of breed. DATATRAK  |
|   |       |       |                | EDC gives you an audit trail    |
|   |       |       |                | down to the data field unlike   |
|   |       |       |                | many systems that give you a    |
|   |       |       |                | snapshot at each page turn      |
|   |       |       |                | (roughly equivalent to filling  |
|   |       |       |                | out a CRF with a pencil). This  |
|   |       |       |                | also means that if the          |
|   |       |       |                | Investigator loses a            |
|   |       |       |                | communications connection, they |
|   |       |       |                | do not lose data.               |
+---+-------+-------+----------------+---------------------------------+
| 4 | Datas | Datas | <htt           | Datastream delivers security    |
| 7 | tream | tream | p://www.datast | for electronic records and      |
| . |       | 7i    | ream.net/commo | signatures and is able to meet  |
|   |       |       | n/21cfr11.asp> | the individual needs of various |
|   |       |       |                | companies who have to deal with |
|   |       |       |                | *21 CFR 11* concerns.           |
+---+-------+-------+----------------+---------------------------------+
| 4 | Datu  | T     | <http://www    | Trusted Time is a solution for  |
| 8 | mEBus | ruste | .datum.com/tt> | providing the necessary         |
| . | iness | dTime |                | components to meet the          |
|   | Solu  |       |                | e-business need for secure and  |
|   | tions |       |                | non-repudiatable time stamps.   |
|   |       |       |                | It is comprised of two main     |
|   |       |       |                | concepts: the security of the   |
|   |       |       |                | time stamp and the auditability |
|   |       |       |                | of the time stamp. The security |
|   |       |       |                | aspect addresses both the       |
|   |       |       |                | transmission of the time from a |
|   |       |       |                | National Measurement Institute  |
|   |       |       |                | to the local time stamp system  |
|   |       |       |                | and the protection of time and  |
|   |       |       |                | audit information within any of |
|   |       |       |                | the systems that the time stamp |
|   |       |       |                | may reside in along the way.    |
|   |       |       |                | The audit nature of Trusted     |
|   |       |       |                | Time is the storing of time     |
|   |       |       |                | source and cryptographic        |
|   |       |       |                | information within each time    |
|   |       |       |                | component and the               |
|   |       |       |                | PKIX-compliant time stamp       |
|   |       |       |                | itself.                         |
+---+-------+-------+----------------+---------------------------------+
| 4 | Dea   | EDS   | [h             | In 1999, DSI envisioned a       |
| 9 | dline | (     | ttp://www.dead | system that would allow         |
| . | Solu  | Elect | linesolutions. | companies to easily define a    |
|   | tions | ronic | com/dsiEDS.htm | "process" with a tool that was  |
|   | Inc.  | Doc   | ](../www.deadl | easy and quick to use. By using |
|   | (DSI) | ument | inesolutions.c | this tool, an entire process    |
|   |       | ation | om/dsiEDS.htm) | could be defined and then an    |
|   |       | Sy    |                | "electronic batch record" could |
|   |       | stem) |                | then be readily extracted. All  |
|   |       |       |                | of this was done with the goal  |
|   |       |       |                | of helping companies who are    |
|   |       |       |                | committed to meeting the 21 CFR |
|   |       |       |                | Part 11 Specification do        |
|   |       |       |                | exactly that.                   |
+---+-------+-------+----------------+---------------------------------+
| 5 | Dec   | Proce | <ht            | Decision Management             |
| 0 | ision | ssPro | tp://www.proce | International, Inc. develops    |
| . | Manag |       | sspromfg.com/> | leading-edge software for FDA   |
|   | ement |       |                | regulated industries. The       |
|   | Int   |       |                | integrated solution set         |
|   | ernat |       |                | includes a robust               |
|   | ional |       |                | document-authoring and control  |
|   |       |       |                | suite, resource-tracking suite, |
|   |       |       |                | and an RF-enabled Weigh         |
|   |       |       |                | Dispense application. Products  |
|   |       |       |                | are engineered specifically for |
|   |       |       |                | 21 CFR Part 11 compliant        |
|   |       |       |                | environments, and support       |
|   |       |       |                | electronic signatures,          |
|   |       |       |                | real-time data exchange with    |
|   |       |       |                | legacy systems, and handheld    |
|   |       |       |                | barcode scanning technology     |
+---+-------+-------+----------------+---------------------------------+
| 5 | D     | Chrom | [www.dionex.   | New Electronic Signature and    |
| 1 | ionex | eleon | com](http://ww | Signoff feature provides        |
| . | C     |       | w.dionex.com/) | electronic signatures in        |
|   | orpor |       |                | conformance to FDA\'s 21 CFR    |
|   | ation |       |                | Part 11 rules. Unique signoff   |
|   |       |       |                | levels allow users to submit,   |
|   |       |       |                | review, and approve electronic  |
|   |       |       |                | records from CHROMELEON         |
|   |       |       |                | efficiently and completely.     |
+---+-------+-------+----------------+---------------------------------+
| 5 | D     | D     | [http://ww     | Docent explicitly designed      |
| 2 | ocent | ocent | w.docent.com/s | Docent Enterprise to enable     |
| . |       | Enter | olutions/br_21 | pharmaceutical companies to     |
|   |       | prise | CFR11.html](.. | meet the United States Code of  |
|   |       |       | /www.docent.co | Federal Regulations, Section    |
|   |       |       | m/solutions/br | 21, Part 11 requirements of     |
|   |       |       | _21CFR11.html) | managing Electronic Records and |
|   |       |       |                | Electronic Signatures.\         |
|   |       |       |                | \                               |
|   |       |       |                | Docent\'s specific features     |
|   |       |       |                | supporting 21 CFR Part 11       |
|   |       |       |                | include:                        |
|   |       |       |                |                                 |
|   |       |       |                | -   Secure role-based system    |
|   |       |       |                |     access control              |
|   |       |       |                |                                 |
|   |       |       |                | -   Guaranteed unique           |
|   |       |       |                |     non-reusable user accounts  |
|   |       |       |                |                                 |
|   |       |       |                | -   Comprehensive data          |
|   |       |       |                |     management and retrieval    |
|   |       |       |                |     including encrypted storage |
|   |       |       |                |     and network access          |
|   |       |       |                |                                 |
|   |       |       |                | -   Electronic signatures       |
|   |       |       |                |     consist of unique user ids  |
|   |       |       |                |     and an encrypted password   |
|   |       |       |                |                                 |
|   |       |       |                | -   Biometric hardware/software |
|   |       |       |                |     authentication support      |
+---+-------+-------+----------------+---------------------------------+
| 5 | Doc   | MAS   | <ht            | MASTERControl regulates secure  |
| 3 | ument | TERCo | tp://www.maste | access to documents and other   |
| . | Co    | ntrol | rcontrol.com/> | electronic files created in any |
|   | ntrol |       |                | software application.           |
|   | Sys   |       |                | MASTERControl FDA Edition was   |
|   | tems, |       |                | written to address stringent    |
|   | Inc.  |       |                | security requirements for FDA   |
|   |       |       |                | companies. This includes both   |
|   |       |       |                | the enhanced features needed to |
|   |       |       |                | comply with these standards and |
|   |       |       |                | assistance with the on-site     |
|   |       |       |                | validation process.             |
+---+-------+-------+----------------+---------------------------------+
| 5 | Doc   | GMP   | [http://w      | GMPharma is the first           |
| 4 | ument | harma | ww.gmpharma.co | enterprise-wide solution that   |
| . | um/Pr |       | m](http://www. | offers an out-of-the box        |
|   | icewa |       | gmpharma.com/) | e-business platform for global  |
|   | terho |       |                | content management of GMP       |
|   | useCo |       |                | regulated documentation.        |
|   | opers |       |                | Conforming to 21 CFR Part 11    |
|   |       |       |                | requirements, GMPharma cuts     |
|   |       |       |                | operational costs, accelerates  |
|   |       |       |                | transfer times from development |
|   |       |       |                | to manufacturing and improves   |
|   |       |       |                | GMP compliance.                 |
|   |       |       |                |                                 |
|   |       |       |                | Standard functionality includes |
|   |       |       |                | electronic signatures, audit    |
|   |       |       |                | trails, controlled printing     |
|   |       |       |                | with overlays and watermarks,   |
|   |       |       |                | automatic version control,      |
|   |       |       |                | preconfigured life-cycles and   |
|   |       |       |                | role based viewing models.      |
|   |       |       |                | Additionally, GMPharma includes |
|   |       |       |                | deployment packages that        |
|   |       |       |                | accelerate implementation,      |
|   |       |       |                | streamline validation and       |
|   |       |       |                | manage document migration.      |
+---+-------+-------+----------------+---------------------------------+
| 5 | Do    | Qua   | w              | DocWave provides Life & Health  |
| 5 | cWave | lWave | ww.docwave.com | companies with high level       |
| . |       | ^TM^  |                | consulting services and         |
|   |       |       |                | business solutions. Compliant   |
|   |       |       |                | with pharmaceutical good        |
|   |       |       |                | practices, FDA and              |
|   |       |       |                | International regulations,      |
|   |       |       |                | QualWave^™^ is a complete       |
|   |       |       |                | solution for managing Quality   |
|   |       |       |                | Documents, (integrating 21CFR   |
|   |       |       |                | part 11 rules). QualWave^™^ is  |
|   |       |       |                | a part of our \" Wave \"        |
|   |       |       |                | business solutions suite for    |
|   |       |       |                | the R&D, QA, Manufacturing,     |
|   |       |       |                | Distribution and Marketing      |
|   |       |       |                | Departments of Pharmaceutical,  |
|   |       |       |                | Cosmetic and Food Companies     |
+---+-------+-------+----------------+---------------------------------+
| 5 | Doxis | SCCM  | [www.doxis     | Doxis and 21 CFR Part 11        |
| 6 |       |       | .com](http://w | Compliance                      |
| . |       |       | ww.doxis.com/) |                                 |
|   |       |       |                | Allows you to keep process      |
|   |       |       |                | records (required by GMPs)      |
|   |       |       |                | securely and in strict          |
|   |       |       |                | compliance with 21 CFR Part 11  |
|   |       |       |                |                                 |
|   |       |       |                | Has been designed to ensure     |
|   |       |       |                | record authenticity and         |
|   |       |       |                | integrity - features are        |
|   |       |       |                | carefully crafted to provide:   |
|   |       |       |                |                                 |
|   |       |       |                | Strict control of user access,  |
|   |       |       |                | and of permitted user actions   |
|   |       |       |                | by role                         |
|   |       |       |                |                                 |
|   |       |       |                | Accurate and easy date          |
|   |       |       |                | retrieval for authorized users  |
|   |       |       |                |                                 |
|   |       |       |                | Automatic audit trailing of     |
|   |       |       |                | data entries and user actions   |
|   |       |       |                |                                 |
|   |       |       |                | Provides options for biometric  |
|   |       |       |                | (handwritten) and non-biometric |
|   |       |       |                | electronic signatures           |
|   |       |       |                |                                 |
|   |       |       |                | Automatically stamps all data   |
|   |       |       |                | entries and signatures with     |
|   |       |       |                | date, time, and user            |
|   |       |       |                | identification                  |
|   |       |       |                |                                 |
|   |       |       |                | Binds all e-signatures to their |
|   |       |       |                | records, so they cannot be      |
|   |       |       |                | excised or copied               |
+---+-------+-------+----------------+---------------------------------+
| 5 | DSI   | d     | [              | Deadline Solutions, Inc.        |
| 7 |       | siEDS | www.deadlineso | delivers high quality           |
| . |       |       | lutions.com]() | Client/Server and Internet      |
|   |       | SCA   |                | enabled applications that will  |
|   |       | DAeds |                | provide 21 CFR Part 11          |
|   |       |       |                | Compliance for the Food and     |
|   |       |       |                | Drug Industries.                |
|   |       |       |                |                                 |
|   |       |       |                | DSI\'s Electronic Documentation |
|   |       |       |                | System (dsiEDS) is a Rapid      |
|   |       |       |                | Application Development tool    |
|   |       |       |                | that is used by our staff to    |
|   |       |       |                | quickly create a                |
|   |       |       |                | \'Manufacturing/Production      |
|   |       |       |                | Process\' or map functionality  |
|   |       |       |                | to a given piece of process     |
|   |       |       |                | equipment. Any given piece of   |
|   |       |       |                | data can then be selected as    |
|   |       |       |                | passive or required to have an  |
|   |       |       |                | electronic signature to ensure  |
|   |       |       |                | compliance.                     |
|   |       |       |                |                                 |
|   |       |       |                | DSI\'s SCADA Electronic         |
|   |       |       |                | Documentation System (SCADAeds) |
|   |       |       |                | takes the best features of      |
|   |       |       |                | dsiEDS and ties it to the       |
|   |       |       |                | pharmaceutical industry\'s most |
|   |       |       |                | popular packaging line          |
|   |       |       |                | hardware. SCADAeds currently    |
|   |       |       |                | works with Ramsey AC4000/AC9000 |
|   |       |       |                | checkweighers, Lakso Fillers,   |
|   |       |       |                | Omega Unscramblers, and Fowler  |
|   |       |       |                | Cappers.                        |
+---+-------+-------+----------------+---------------------------------+
| 5 | DUII  | LIMS  | [w             | DUII develops and markets its   |
| 8 |       |       | ww.duii.com]() | products and services of        |
| . |       |       |                | laboratory information          |
|   |       |       |                | management system (LIMS),       |
|   |       |       |                | 21CFR11-aware computational     |
|   |       |       |                | infrastructure, and Standard    |
|   |       |       |                | Operating Procedure             |
|   |       |       |                | (SOP)-driven networks. These    |
|   |       |       |                | satisfy the requirements of     |
|   |       |       |                | 21CRF11 by authority check,     |
|   |       |       |                | operational system check,       |
|   |       |       |                | device check, SOP, electronic   |
|   |       |       |                | signature and closed systems.   |
|   |       |       |                | DUII creates tools to enhance   |
|   |       |       |                | communication and to enforce    |
|   |       |       |                | compliance.                     |
+---+-------+-------+----------------+---------------------------------+
| 5 | EMed  | MCS   | [h             | eMedia-IT\'s web-based          |
| 9 | ia-IT | *Now* | ttp://www.emed | infrastructure allows your      |
| . |       |       | iait.com/produ | company to meeting key FDA      |
|   |       |       | cts/index.html | compliancy requirements while   |
|   |       |       | ](../www.emedi | managing the secure sharing of  |
|   |       |       | ait.com/produc | files within your organization  |
|   |       |       | ts/index.html) | as well as with other           |
|   |       |       |                | organizations, and implementing |
|   |       |       |                | features such as:               |
|   |       |       |                |                                 |
|   |       |       |                | -   User authentication upon    |
|   |       |       |                |     login                       |
|   |       |       |                |                                 |
|   |       |       |                | -   Dynamic file viewing        |
|   |       |       |                |                                 |
|   |       |       |                | -   Group and user management   |
|   |       |       |                |                                 |
|   |       |       |                | -   File and folder access      |
|   |       |       |                |     permissions                 |
|   |       |       |                |                                 |
|   |       |       |                | -   Version control and file    |
|   |       |       |                |     history                     |
|   |       |       |                |                                 |
|   |       |       |                | -   Read-only audit trail       |
+---+-------+-------+----------------+---------------------------------+
| 6 | Em    | De    | [http          | The DeltaV™ digital automation  |
| 0 | erson | ltaV™ | ://easydeltav. | system delivers integrated      |
| . | Pr    |       | com](http://ea | batch automation that's easy to |
|   | ocess |       | sydeltav.com/) | engineer, easy to use, and easy |
|   | Manag |       |                | to validate. It's built to S88  |
|   | ement |       |                | standards and fully addresses   |
|   |       |       |                | the FDA's 21 CFR Part 11        |
|   |       |       |                | requirements with integrated    |
|   |       |       |                | recipe and campaign management, |
|   |       |       |                | batch history, automatic        |
|   |       |       |                | version control, and change     |
|   |       |       |                | management.                     |
+---+-------+-------+----------------+---------------------------------+
| 6 | Enmed | Accel | <http://w      | Enmed\'s Acceliant™ Clinical    |
| 1 |       | iant™ | ww.enmed.com/> | Trial Solution is a             |
| . |       |       |                | comprehensive, flexible, and    |
|   |       |       |                | integrated solution designed to |
|   |       |       |                | improve the speed and           |
|   |       |       |                | efficiency of clinical          |
|   |       |       |                | development. The Acceliant      |
|   |       |       |                | Clinical Trial Solution has     |
|   |       |       |                | been designed to exceed current |
|   |       |       |                | industry regulations for        |
|   |       |       |                | clinical trial software,        |
|   |       |       |                | including the FDA\'s 21 CFR     |
|   |       |       |                | Part 11.                        |
+---+-------+-------+----------------+---------------------------------+
| 6 | Ensur | Docu  | [http://ww     | Biotechnology research,         |
| 2 | eLink | Store | w.ensurelink.c | discoveries and applications    |
| . |       | Repos | om/resources.h | ultimately find their way to    |
|   |       | itory | tml](../www.en | public use. Under the auspices  |
|   |       |       | surelink.com/r | of the Health Care Insurance    |
|   |       | eNow™ | esources.html) | Portability and Accountability  |
|   |       |       |                | Act (HIPAA) and FDA regulation  |
|   |       |       |                | 21CFRPART 11, any entity that   |
|   |       |       |                | accepts, maintains or transmits |
|   |       |       |                | electronic data must comply     |
|   |       |       |                | with a standardized Electronic  |
|   |       |       |                | Data Interchange (EDI) format.  |
|   |       |       |                | The FDA, in particular, has     |
|   |       |       |                | indicated it is committed to a  |
|   |       |       |                | set of regulations that apply   |
|   |       |       |                | to all areas of electronic      |
|   |       |       |                | technology that are compatible  |
|   |       |       |                | with the FDA\'s mandate to      |
|   |       |       |                | promote and protect public      |
|   |       |       |                | health. It is reasonable to     |
|   |       |       |                | expect the FDA regulations to   |
|   |       |       |                | be even more broad-based than   |
|   |       |       |                | those of other agencies, and    |
|   |       |       |                | for the other agencies to       |
|   |       |       |                | broaden their rules to meet     |
|   |       |       |                | expanded FDA requirements. Any  |
|   |       |       |                | firm that produces information  |
|   |       |       |                | or products that eventually     |
|   |       |       |                | reach the public will fall      |
|   |       |       |                | under the auspices of the new,  |
|   |       |       |                | emerging \"alphabet-soup\"      |
|   |       |       |                | regulatory environment. Those   |
|   |       |       |                | who begin with security         |
|   |       |       |                | protocol in place are laying    |
|   |       |       |                | the groundwork for successful   |
|   |       |       |                | long term industry and market   |
|   |       |       |                | leadership.                     |
+---+-------+-------+----------------+---------------------------------+
| 6 | En    | En    | [http:/        | Digital Certificate technology  |
| 3 | trust | trust | /www.entrust.c | can be used to ensure access    |
| . | Te    | /PKI™ | om](http://www | control, authentication and     |
|   | chnol |       | .entrust.com/) | non-repudiation of digital      |
|   | ogies |       |                | transmissions, providing a      |
|   |       |       |                | secure and reliable means of    |
|   |       |       |                | communicating and affecting     |
|   |       |       |                | transactions over public and    |
|   |       |       |                | private networks. The Entrust   |
|   |       |       |                | family of products offers a     |
|   |       |       |                | complete security               |
|   |       |       |                | infrastructure that is          |
|   |       |       |                | supported across multiple       |
|   |       |       |                | platforms and applications.     |
|   |       |       |                | Entrust provides a complete     |
|   |       |       |                | digital certificate-based       |
|   |       |       |                | solution for digital signature  |
|   |       |       |                | and encryption, that will meet  |
|   |       |       |                | the requirements of the FDA for |
|   |       |       |                | organizations that want to use  |
|   |       |       |                | electronic records and          |
|   |       |       |                | electronic signatures.          |
+---+-------+-------+----------------+---------------------------------+
| 6 | eOri  | *     | [www           | The ***e***Original™ system     |
| 4 | ginal | **e** | .eoriginal.com | meets or exceeds all of the FDA |
| . | Inc.  | *Orig | ](http://www.e | requirements for electronic     |
|   |       | inal™ | original.com/) | filings                         |
+---+-------+-------+----------------+---------------------------------+
| 6 | Et    | i     | [htt           | etrials offers iSuite, an       |
| 5 | rials | Suite | p://www.etrial | innovative and powerful data    |
| . |       |       | s.com/edc_depl | entry system that allows        |
|   |       |       | oy.htm](../www | investigators and site          |
|   |       |       | .etrials.com/e | administrators to make          |
|   |       |       | dc_deploy.htm) | immediate decisions based on    |
|   |       |       |                | having cleaner data \-- faster. |
|   |       |       |                |                                 |
|   |       |       |                | Our eCRF form is 21 CFR Part 11 |
|   |       |       |                | compliant.                      |
+---+-------+-------+----------------+---------------------------------+
| 6 | EtQ   | A     | [http://www.kn | EtQ Solutions® is a complete    |
| 6 | Solut | Br    | owledgearc.com | ISO/QS 9000 solution, now **21  |
| . | ions® | owser | /](../www.know | CFR Part 11** compliant. The    |
|   |       | Based | ledgearc.com/) | workflow engine under girds     |
|   |       | Suite |                | solutions for ISO 9000, QS      |
|   |       |       |                | 9000, ISO 14000, including      |
|   |       |       |                | Document Control, Corrective    |
|   |       |       |                | Action, Audits, APQP, Training, |
|   |       |       |                | etc.                            |
+---+-------+-------+----------------+---------------------------------+
| 6 | First | First | [              | First Consulting Group (FCG)    |
| 7 | Consu | Docs™ | www.fcg.com]() | has combined the industry\'s    |
| . | lting |       |                | best practices,                 |
|   | Group |       |                | state-of-the-art technology,    |
|   |       |       |                | and consulting services to      |
|   |       |       |                | produce FirstDocs™ for GMP, a   |
|   |       |       |                | comprehensive prepackaged       |
|   |       |       |                | electronic document management  |
|   |       |       |                | solution in support of          |
|   |       |       |                | pharmaceutical manufacturing    |
|   |       |       |                | and quality processes. It\'s a  |
|   |       |       |                | part of our FirstDocs™ solution |
|   |       |       |                | suite, which offers a set of    |
|   |       |       |                | services and software for       |
|   |       |       |                | research and development, case  |
|   |       |       |                | report form management, and     |
|   |       |       |                | regulatory submissions.         |
+---+-------+-------+----------------+---------------------------------+
| 6 | Fishe | D     | <http://       | Significant batch enhancements  |
| 8 | r-Ros | eltaV | www.frco.com/> | in the Version 5 release        |
| . | emont |       |                | include support for both        |
|   |       |       |                | running batches in campaigns    |
|   |       |       |                | and enhancements focused to     |
|   |       |       |                | support FDA regulations in 21   |
|   |       |       |                | CFR Part 11.                    |
|   |       |       |                |                                 |
|   |       |       |                | New patented Configuration      |
|   |       |       |                | Audit Trail software controls,  |
|   |       |       |                | manages and tracks all changes  |
|   |       |       |                | to the DeltaV configuration     |
|   |       |       |                | database saving time, effort    |
|   |       |       |                | and improving accuracy of       |
|   |       |       |                | configuration management. This  |
|   |       |       |                | software supports electronic    |
|   |       |       |                | record keeping per 21 CFR Part  |
|   |       |       |                | 11.                             |
+---+-------+-------+----------------+---------------------------------+
| 6 | Fle   | 21    | [http:         | Flexware Integration's 21 CFR   |
| 9 | xware | CFR   | //www.flexint. | Part 11 Remediation Toolkit was |
| . | I     | Part  | com/21cfrpart1 | designed to help simplify the   |
|   | ntegr | 11    | 1.asp](../www. | remediation process for         |
|   | ation | R     | flexint.com/21 | client/server systems. It can   |
|   |       | emedi | cfrpart11.asp) | drastically reduce your cost of |
|   |       | ation |                | remediation by providing        |
|   |       | To    |                | \"common solutions to common    |
|   |       | olkit |                | problems.\"                     |
+---+-------+-------+----------------+---------------------------------+
| 7 | Foss  | V     | [w             | Foss NIRSystems, Inc., a unit   |
| 0 | N     | ision | ww.foss-nirsys | of Foss A/S of Denmark, is the  |
| . | IRSys |       | tems.com](http | world\'s leading supplier of    |
|   | tems, |       | ://www.foss-ni | scanning Near Infrared products |
|   | Inc.  |       | rsystems.com/) | and services for the            |
|   |       |       |                | pharmaceutical and chemical     |
|   |       |       |                | markets. Our extensive          |
|   |       |       |                | application knowledge, global   |
|   |       |       |                | distribution, and support       |
|   |       |       |                | network ensures efficient       |
|   |       |       |                | method development and routine  |
|   |       |       |                | implementation for years to     |
|   |       |       |                | come. Our software is fully     |
|   |       |       |                | compliant to 21 CFR, Part 11    |
|   |       |       |                | for the benefit of our          |
|   |       |       |                | pharmaceutical customers.       |
+---+-------+-------+----------------+---------------------------------+
| 7 | Gould | Gould | [http://       | Data Security -An optional Data |
| 1 | Instr | Life  | www.gouldis.co | Security feature provides       |
| . | ument | Sc    | m/ponemah_Iss. | compliance to FDA 21 CFR Part   |
|   | Sy    | ience | html](../www.g | 11.                             |
|   | stems | Suite | ouldis.com/pon |                                 |
|   |       |       | emah_Iss.html) |                                 |
+---+-------+-------+----------------+---------------------------------+
| 7 | H&A   | SLIM  | <http:         | "21 CFR Part 11 Compliant";     |
| 2 | S     |       | //hascientific | "All changes are event logged.  |
| . | cient |       | .com/slim.htm> | Audit trail includes references |
|   | ific, |       |                | to the date and time of the     |
|   | Inc.  |       |                | change, the user making the     |
|   |       |       |                | change, the event type that     |
|   |       |       |                | caused the event to be logged,  |
|   |       |       |                | and description. When data      |
|   |       |       |                | results are changed a change    |
|   |       |       |                | code and comments are logged.   |
|   |       |       |                | Multiple levels of security. "  |
+---+-------+-------+----------------+---------------------------------+
| 7 | Her   | GainS | [h             | In response to the growing need |
| 3 | tzler | eeker | ttp://www.hert | to find more powerful software  |
| . | Sys   | Suite | zler.com/html/ | to help manufacturers and       |
|   | tems, |       | news_pr_v7.asp | businesses collect, manage,     |
|   | Inc.  |       | ](../www.hertz | analyze and report quality      |
|   |       |       | ler.com/html/n | information, Hertzler Systems   |
|   |       |       | ews_pr_v7.asp) | is introducing their newest     |
|   |       |       |                | product, QA/S GainSeeker® 7     |
|   |       |       |                | Suite. Among the dozens of new  |
|   |       |       |                | features in the new release,    |
|   |       |       |                | noted highlights include:       |
|   |       |       |                |                                 |
|   |       |       |                | -   Additional security         |
|   |       |       |                |     features such as enhanced   |
|   |       |       |                |     21 CFR Part 11 compliance.  |
+---+-------+-------+----------------+---------------------------------+
| 7 | He    | C     | [www.agilent.c | Agilent Cerity Networked Data   |
| 4 | wlett | erity | om](http://www | System for Pharmaceutical QA/QC |
| . | Pa    |       | .agilent.com/) | data system, based on Microsoft |
|   | ckard |       |                | Windows NT® 32-bit              |
|   |       |       |                | architecture, is part of the    |
|   |       |       |                | Agilent Cerity networked data   |
|   |       |       |                | system family of chromatography |
|   |       |       |                | software. (Formerly             |
|   |       |       |                | Chemstation.)                   |
+---+-------+-------+----------------+---------------------------------+
| 7 | Hone  | POMS  | <http://       | Honeywell-POMS Corporation is   |
| 5 | ywell |       | www.poms.com/> | the global leader in providing  |
| . | -POMS |       |                | Manufacturing Execution Systems |
|   |       |       |                | (MES) for the healthcare        |
|   |       |       |                | products and consumer packaged  |
|   |       |       |                | goods industries. The           |
|   |       |       |                | company\'s solutions are an     |
|   |       |       |                | essential component to          |
|   |       |       |                | successful E-Business supply    |
|   |       |       |                | chains, providing manufacturers |
|   |       |       |                | with agility in their product   |
|   |       |       |                | development and manufacturing   |
|   |       |       |                | operations.                     |
|   |       |       |                |                                 |
|   |       |       |                | Honeywell-POMS provides         |
|   |       |       |                | integrated solutions that help  |
|   |       |       |                | you control, track, and view    |
|   |       |       |                | every aspect of your product    |
|   |       |       |                | development life cycle. Our     |
|   |       |       |                | solutions are in use within     |
|   |       |       |                | Clinical and Commercial         |
|   |       |       |                | Pharmaceuticals, Biotechnology  |
|   |       |       |                | Products, Medical Devices,      |
|   |       |       |                | Primary Pharmaceutical          |
|   |       |       |                | Chemicals, and Nutritional      |
|   |       |       |                | Products organizations. POMS    |
|   |       |       |                | products deliver value and help |
|   |       |       |                | you:                            |
+---+-------+-------+----------------+---------------------------------+
| 7 | I     | 2.0   | [www.laboc     | The new Version 2.0 Dissolution |
| 6 | calis | D     | at.nl/Icalis/L | Data Management software from   |
| . | Data  | issol | aboCAT_Icalis_ | Icalis Data Systems employ an   |
|   | Sy    | ution | Page_2a.htm]() | extensive range of restrictive  |
|   | stems | Data  |                | access rights to aid compliance |
|   |       | Manag |                | to 21 CFR Part 11 and Online    |
|   |       | ement |                | Sample processing with          |
|   |       | Sof   |                | Autosamplers including sample   |
|   |       | tware |                | dilution.                       |
|   |       |       |                |                                 |
|   |       |       |                | Icalis FDA 21 CFR part 11       |
|   |       |       |                | allows the company to comply    |
|   |       |       |                | with this requirement of record |
|   |       |       |                | keeping and authentication, by  |
|   |       |       |                | having the possibility to       |
|   |       |       |                | specify records or Groups of    |
|   |       |       |                | records that must be signed.    |
|   |       |       |                | The company can also specify    |
|   |       |       |                | which Users can sign records,   |
|   |       |       |                | which records and how many      |
|   |       |       |                | users are required for          |
|   |       |       |                | signature. Records specified    |
|   |       |       |                | for signing clearly show this   |
|   |       |       |                | requirement if printed and the  |
|   |       |       |                | status of the singing. An audit |
|   |       |       |                | trail is kept of all activity   |
|   |       |       |                | in the system which is also     |
|   |       |       |                | user queryable to help keep     |
|   |       |       |                | information in an orderly       |
|   |       |       |                | manner.                         |
+---+-------+-------+----------------+---------------------------------+
| 7 | Ic    | Gene  | [www.icon      | ICONICS, a leader in the        |
| 7 | onics | sis32 | ics.com](../ww | development of Web-enabled      |
| . |       |       | w.iconics.com) | OPC-based industrial automation |
|   |       |       |                | software for Microsoft^®^       |
|   |       |       |                | Windows^®^ operating systems,   |
|   |       |       |                | announced that Version 6.1 of   |
|   |       |       |                | GENESIS32™ offers a wide        |
|   |       |       |                | variety of tools for complying  |
|   |       |       |                | with the FDA 21 CFR 11          |
|   |       |       |                | regulations. It enables proper  |
|   |       |       |                | handling and recording of       |
|   |       |       |                | FDA-regulated electronic        |
|   |       |       |                | information, and applies        |
|   |       |       |                | \"electronic signatures\" such  |
|   |       |       |                | that the FDA considers them to  |
|   |       |       |                | be \"equivalent\" to that of    |
|   |       |       |                | handwritten signatures and      |
|   |       |       |                | documents.                      |
+---+-------+-------+----------------+---------------------------------+
| 7 | Ind   | Xt    | [www.m         | We offer a breakthrough,        |
| 8 | ustry | rials | ymatrixml.com/ | workgroup management technology |
| . | Dyn   |       | xTrials.pdf]() | that is native XML-based, fully |
|   | amics |       |                | 21 CFR Part 11 compliant, and   |
|   | A     |       |                | able to be customized for       |
|   | ssoci |       |                | individual company              |
|   | ates, |       |                | implementations in a fraction   |
|   | Inc.  |       |                | of the time of competitive      |
|   |       |       |                | offerings. The XTrials ^TM^     |
|   |       |       |                | Application Architecture is a   |
|   |       |       |                | fully-scalable clinical data    |
|   |       |       |                | management environment that     |
|   |       |       |                | harnesses the power XML for     |
|   |       |       |                | EDC, Clinical Data Review, CSR  |
|   |       |       |                | Analysis/Verification/Peer      |
|   |       |       |                | review, and electronic          |
|   |       |       |                | Regulatory Submissions          |
|   |       |       |                | production.                     |
+---+-------+-------+----------------+---------------------------------+
| 7 | Info  | eP    | <http://www.i  | Infotehna is committed to       |
| 9 | tehna | harma | nfotehna.com/> | providing integrated solutions  |
| . |       |       |                | for pharmaceutical industries,  |
|   |       |       |                | covering regulatory affairs,    |
|   |       |       |                | QA/QC are a procedures          |
|   |       |       |                | management, and change control. |
|   |       |       |                | It combines experience and      |
|   |       |       |                | technology to produce ePharma,  |
|   |       |       |                | a comprehensive suite of        |
|   |       |       |                | applications, designed          |
|   |       |       |                | specifically for pharmaceutical |
|   |       |       |                | and process industries. ePharma |
|   |       |       |                | is ready for the efficient and  |
|   |       |       |                | effective implementations       |
|   |       |       |                | featuring two major components, |
|   |       |       |                | GLORYA and eProcess Manager.    |
|   |       |       |                | Both applications are           |
|   |       |       |                | completely internet/intranet    |
|   |       |       |                | based, utilize full life cycle  |
|   |       |       |                | support of Documentum D4i, and  |
|   |       |       |                | XML                             |
+---+-------+-------+----------------+---------------------------------+
| 8 | Inna  | Wa    | [http://www    | Watson™ uses a central Oracle™  |
| 0 | Phase | tson™ | .innaphase.com | database and offers a simple,   |
| . |       | LIMS  | ](http://www.i | point-and-click graphical       |
|   |       |       | nnaphase.com/) | interface that is quick to      |
|   |       |       |                | learn and easy to use. Watson ™ |
|   |       |       |                | has been expressly built to     |
|   |       |       |                | promote compliance with GLP     |
|   |       |       |                | regulations and the 21 CFR Part |
|   |       |       |                | 11 guidance. The system         |
|   |       |       |                | security and audit trail are    |
|   |       |       |                | designed to provide maximum     |
|   |       |       |                | flexibility and configurability |
|   |       |       |                | to our clients while preserving |
|   |       |       |                | data integrity. Watson™ is      |
|   |       |       |                | capable of handling standard    |
|   |       |       |                | and complex study protocols,    |
|   |       |       |                | providing audit trails to track |
|   |       |       |                | deviations and amendments to    |
|   |       |       |                | each study. Watson™ has full    |
|   |       |       |                | bi-directional interface        |
|   |       |       |                | capability to analytical        |
|   |       |       |                | instruments, tracks shipments   |
|   |       |       |                | and samples through             |
|   |       |       |                | user-designed barcode labels,   |
|   |       |       |                | supports a wide range of PK/TK  |
|   |       |       |                | analyses, and organizes study   |
|   |       |       |                | results in a unique document    |
|   |       |       |                | management system. Watson™ also |
|   |       |       |                | fully supports unit management, |
|   |       |       |                | allowing true data              |
|   |       |       |                | consolidation across studies    |
|   |       |       |                | and projects.                   |
+---+-------+-------+----------------+---------------------------------+
| 8 | In    | iFix  | <              | Intellution, Inc., the world\'s |
| 1 | tellu |       | http://www.int | leading developer of industrial |
| . | tion, | i     | ellution.com/> | automation software, has been   |
|   | Inc.  | Batch |                | developing and delivering the   |
|   |       |       |                | industry\'s most advanced       |
|   |       |       |                | HMI/SCADA, batch, softlogic,    |
|   |       |       |                | and internet solutions to top   |
|   |       |       |                | manufacturers for more than 20  |
|   |       |       |                | years.                          |
|   |       |       |                |                                 |
|   |       |       |                | In an effort to help businesses |
|   |       |       |                | from across the FDA-regulated   |
|   |       |       |                | spectrum comply with 21 CFR     |
|   |       |       |                | Part 11, Intellution has taken  |
|   |       |       |                | a leadership role in developing |
|   |       |       |                | software-level solutions to     |
|   |       |       |                | meet the demands of this        |
|   |       |       |                | critical regulation. Working in |
|   |       |       |                | unison with key biotech and     |
|   |       |       |                | pharmaceutical representatives, |
|   |       |       |                | FDA regulatory personnel,       |
|   |       |       |                | original equipment              |
|   |       |       |                | manufacturers and systems       |
|   |       |       |                | integrators, Intellution is     |
|   |       |       |                | developing the tools that will  |
|   |       |       |                | empower all FDA-regulated       |
|   |       |       |                | companies to come into          |
|   |       |       |                | compliance.                     |
+---+-------+-------+----------------+---------------------------------+
| 8 | Inter | Tra   | <http://www.ih | The Food and Drug               |
| 2 | pharm | ining | shealthgroup.c | Administration (FDA) mandates   |
| . | Press | Tr    | om/pressreleas | strict regulations regarding    |
|   |       | acker | es/press9.htm> | electronic signatures and audit |
|   |       | III   |                | trailing on electronic data     |
|   |       |       |                | collection methods under 21 CFR |
|   |       |       |                | Part 11. Healthcare             |
|   |       |       |                | manufacturers using electronic  |
|   |       |       |                | record-keeping systems must     |
|   |       |       |                | comply with stringent           |
|   |       |       |                | regulations regarding the       |
|   |       |       |                | training of their employees,    |
|   |       |       |                | including the methods of        |
|   |       |       |                | recording and reporting such    |
|   |       |       |                | training for audits.            |
|   |       |       |                |                                 |
|   |       |       |                | Training Tracker III helps      |
|   |       |       |                | companies stay in compliance    |
|   |       |       |                | with these regulations by       |
|   |       |       |                | tracking employee training      |
|   |       |       |                | records and cross-referencing   |
|   |       |       |                | employees with their job titles |
|   |       |       |                | / grades, courses required for  |
|   |       |       |                | those jobs, instructors and     |
|   |       |       |                | course scheduling. Once an      |
|   |       |       |                | employee\'s training has been   |
|   |       |       |                | completed, the information is   |
|   |       |       |                | recorded with the electronic    |
|   |       |       |                | signature, and all changes to   |
|   |       |       |                | that record are also date- and  |
|   |       |       |                | time-stamped for auditing       |
|   |       |       |                | purposes.                       |
+---+-------+-------+----------------+---------------------------------+
| 8 | Inv   | Fo    | <ht            | Invensys Pharmaceutical         |
| 3 | ensys | xboro | tp://www.foxbo | Solutions, a division of        |
| . |       | I/A   | ro.com/iaserie | Invensys Production Management  |
|   |       | Sys   | s/automation_s | is a leading supplier of        |
|   |       | tems; | ystems/hottopi | manufacturing control (Foxboro  |
|   |       | W     | cs/21_cfr.htm> | I/A Series System, Wonderware), |
|   |       | onder |                | manufacturing execution         |
|   |       | ware; |                | (Avantis) and environmental     |
|   |       | Ava   |                | systems (Eurotherm) that meet   |
|   |       | ntis; |                | and exceed the guidelines of 21 |
|   |       | Euro  |                | CFR part 11. Invensys           |
|   |       | therm |                | Pharmaceutical Solutions has a  |
|   |       |       |                | dedicated group of              |
|   |       |       |                | pharmaceutical engineers and    |
|   |       |       |                | specialists focused on this     |
|   |       |       |                | industry, regulations, and new  |
|   |       |       |                | technology tools. Our unique    |
|   |       |       |                | solution includes a full range  |
|   |       |       |                | of products, automated tools,   |
|   |       |       |                | validation services (VTI), and  |
|   |       |       |                | procedures to help comply to 21 |
|   |       |       |                | CFR part 11. We leverage our    |
|   |       |       |                | expertise to provide systems,   |
|   |       |       |                | tools, policies, and procedures |
|   |       |       |                | for compliance.                 |
+---+-------+-------+----------------+---------------------------------+
| 8 | I     | Da    | <http:/        | Ionics Instrument Business      |
| 4 | onics | taPro | /www.ionicsins | Group (formerly Sievers         |
| . | Instr | /Data | truments.com/> | Instruments) makes the world\'s |
|   | ument | Guard |                | most sensitive and selective    |
|   | Bus   |       |                | scientific instruments to       |
|   | iness |       |                | measure total organic carbon    |
|   | Group |       |                | (TOC) for the pharmaceutical,   |
|   |       |       |                | semiconductor and power         |
|   |       |       |                | industries. A 21 CFR 11         |
|   |       |       |                | compliant Sievers brand TOC     |
|   |       |       |                | system is available with a new  |
|   |       |       |                | DataPro/DataGuard software      |
|   |       |       |                | package that includes audit     |
|   |       |       |                | trails, electronic signatures   |
|   |       |       |                | and user-level security.        |
+---+-------+-------+----------------+---------------------------------+
| 8 | Iso   | Iso   | <http://www.   | ISOtrain Training Management    |
| 5 | train | train | isotrain.com/> | Solution is a powerful          |
| . |       | Tra   |                | compliance driven, quality      |
|   |       | ining |                | based training tracking system. |
|   |       | Manag |                | ISOtrain allows you to manage   |
|   |       | ement |                | employee training records on    |
|   |       | Sol   |                | your global network. With a     |
|   |       | ution |                | click of a button, you can      |
|   |       |       |                | notify employees of scheduled   |
|   |       |       |                | training, e-mail a report to    |
|   |       |       |                | management, review employee     |
|   |       |       |                | qualifications, or retrieve a   |
|   |       |       |                | course outline. ISOtrain runs   |
|   |       |       |                | on multiple desktop platforms,  |
|   |       |       |                | network operating systems and   |
|   |       |       |                | databases. Validation is made   |
|   |       |       |                | easy with a comprehensive       |
|   |       |       |                | validation package.             |
+---+-------+-------+----------------+---------------------------------+
| 8 | J.D.  | J.D.  | [www           | Designed to meet the needs of   |
| 6 | Ed    | Ed    | .jdedwards.com | regulated companies, J.D.       |
| . | wards | wards | ](http://www.j | Edwards OneWorld solutions not  |
|   |       | One   | dedwards.com/) | only ensure the integrity of    |
| J |       | World |                | authorized signatures executed  |
|   |       |       |                | within the OneWorld             |
|   |       |       |                | environment, they also enable   |
|   |       |       |                | companies to feel secure that   |
|   |       |       |                | the transactions being executed |
|   |       |       |                | are meeting the approval, audit |
|   |       |       |                | trail, and time stamping        |
|   |       |       |                | functions required in 21 CFR    |
|   |       |       |                | Part 11.                        |
+---+-------+-------+----------------+---------------------------------+
| 8 | Kaye  | Vali  | <http://www    | The **Validator 2000** meets    |
| 7 | I     | dator | .kayeinc.com/> | all the new FDA regulations for |
| . | nstru | 2000  |                | thermal validation, including   |
|   | ments |       |                | 21 CFR Part 11 on electronic    |
|   |       | Lab   |                | signatures and records. It      |
|   |       | Watch |                | provides many time-saving       |
|   |       |       |                | benefits such as automating     |
|   |       |       |                | sensor calibration and report   |
|   |       |       |                | generation.                     |
|   |       |       |                |                                 |
|   |       |       |                | The **LabWatch** System         |
|   |       |       |                | operates in compliance with the |
|   |       |       |                | FDA regulation on 21 CFR Part   |
|   |       |       |                | 11 Electronic Signatures and    |
|   |       |       |                | Records                         |
+---+-------+-------+----------------+---------------------------------+
| 8 | Lab   | Debra | [http://w      | Debra, by Lablogic Systems,     |
| 8 | Logic |       | ww.lablogic.co | Ltd., is a Protocol-Driven      |
| . | Sy    | Laura | m](http://www. | GLP-Compliant Laboratory        |
|   | stems |       | lablogic.com/) | Information System (LIMS)       |
|   | Ltd.  |       |                | designed to meet the unique     |
|   |       |       |                | needs of an ADME Laboratory     |
|   |       |       |                | environment                     |
|   |       |       |                |                                 |
|   |       |       |                | Laura 3 is the latest evolution |
|   |       |       |                | of the widely used Laura        |
|   |       |       |                | chromatography acquisition and  |
|   |       |       |                | analysis system from LabLogic.  |
|   |       |       |                | Produced to accommodate the     |
|   |       |       |                | latest networks platforms Laura |
|   |       |       |                | 3 offers the researcher the     |
|   |       |       |                | facility to create and edit     |
|   |       |       |                | methods, set up sample runs and |
|   |       |       |                | view data collection in real    |
|   |       |       |                | time across the network without |
|   |       |       |                | being confined to the bench-top |
|   |       |       |                | PC.                             |
+---+-------+-------+----------------+---------------------------------+
| 8 | L     | Lims  | [www.l         | For over 14 years Labtronics    |
| 9 | abtro | Link™ | abtronics.com] | has been recognized as a world  |
| . | nics, |       | (http://www.la | leader in innovative instrument |
|   | Inc.  | LimsL | btronics.com/) | interfacing technology.         |
|   |       | ink*^ |                | LimsLink is the complete        |
|   |       | CDS^* |                | instrument to LIMS interfacing  |
|   |       |       |                | solution, designed to collect   |
|   |       |       |                | data from a broad range of      |
|   |       |       |                | instruments, reformat that data |
|   |       |       |                | and report it to any LIMS or    |
|   |       |       |                | database application.           |
|   |       |       |                |                                 |
|   |       |       |                | With 100 levels of password     |
|   |       |       |                | protection and a full audit     |
|   |       |       |                | trail implementation,           |
|   |       |       |                | LimsLink*^CDS^* provides the    |
|   |       |       |                | level of security and           |
|   |       |       |                | accountability required to make |
|   |       |       |                | it a necessary and valuable     |
|   |       |       |                | component for 21 CFR Part 11    |
|   |       |       |                | compliance.                     |
+---+-------+-------+----------------+---------------------------------+
| 9 | La    | La    | [www.          | LabWare Inc. has been an        |
| 0 | bware | bWare | labware.com]() | established leader in supplying |
| . | Inc.  | LIMS  |                | Laboratory Information          |
|   |       |       |                | Management Systems and          |
|   |       |       |                | instrument integration software |
|   |       |       |                | to companies in diverse         |
|   |       |       |                | industries worldwide since      |
|   |       |       |                | 1988. LabWare\'s successful     |
|   |       |       |                | validation record and           |
|   |       |       |                | compliance to 21 CRF Part 11    |
|   |       |       |                | guidelines are some of the      |
|   |       |       |                | reasons why many of the         |
|   |       |       |                | world\'s pharmaceutical         |
|   |       |       |                | companies have standardized on  |
|   |       |       |                | LabWare LIMS.                   |
+---+-------+-------+----------------+---------------------------------+
| 9 | L     | Gou   | [www.li        | The P3-Plus Data Security       |
| 1 | inton | ld-Po | ntoninst.co.uk | Option utilizes a 'Smart Card'  |
| . | Instr | NeMah | /P3PDSO.htm]() | for each user. These smart      |
|   | ument | P3    |                | cards are initialized with      |
|   | ation | -Plus |                | unique encryption               |
|   |       |       |                | Public/Private Key set for      |
|   |       |       |                | digital signatures. P3-Plus     |
|   |       |       |                | Data Security Option uses PKI   |
|   |       |       |                | (Public Key Infrastructure), a  |
|   |       |       |                | legally binding equivalent to a |
|   |       |       |                | handwritten signature -- PKI is |
|   |       |       |                | the standard adopted by         |
|   |       |       |                | Verisign and other leading      |
|   |       |       |                | security/verification           |
|   |       |       |                | organizations. Files can be     |
|   |       |       |                | electronically signed using the |
|   |       |       |                | operator's electronic           |
|   |       |       |                | signature.                      |
+---+-------+-------+----------------+---------------------------------+
| 9 | Li    | Co    | [www.          | CoreDossierX Features           |
| 2 | quent | reDos | liquent.com]() |                                 |
| . |       | sierX |                | -   Can be used alone or in     |
|   |       |       |                |     conjunction with your       |
|   |       |       |                |     document management system  |
|   |       |       |                |                                 |
|   |       |       |                | -   Supports over 135 native    |
|   |       |       |                |     file formats                |
|   |       |       |                |                                 |
|   |       |       |                | -   Select from a wide range of |
|   |       |       |                |     output channels: HTML, PDF, |
|   |       |       |                |     TIFF, CD-ROM, kPortal,      |
|   |       |       |                |     paper, standard PostScript, |
|   |       |       |                |     Docutech PostScript, CDER   |
|   |       |       |                |     and CBER                    |
|   |       |       |                |                                 |
|   |       |       |                | -   Audit trail capabilities    |
|   |       |       |                |     support 21 CFR Part II      |
|   |       |       |                |     compliance on a per         |
|   |       |       |                |     publication basis           |
|   |       |       |                |                                 |
|   |       |       |                | -   Enables the assembly of     |
|   |       |       |                |     smaller publications that   |
|   |       |       |                |     feed into larger            |
|   |       |       |                |     submissions                 |
|   |       |       |                |                                 |
|   |       |       |                | -   Automatic finishing         |
|   |       |       |                |     options: table of contents  |
|   |       |       |                |     generation,                 |
|   |       |       |                |     cross-references, headers,  |
|   |       |       |                |     footers, watermarks and     |
|   |       |       |                |     pagination schemes          |
+---+-------+-------+----------------+---------------------------------+
| 9 | Ma    | Self  | [www.malver    | The digital signature solution  |
| 3 | lvern | -sign | n.co.uk/images | that is provided with the full  |
| . | I     |       | /tb1155%20-%20 | acrobat package is called       |
|   | nstru |       | Electronic%20s | "self-sign". This solution is   |
|   | ments |       | ignatures%20us | 21 CFR Part 11 compliant and    |
|   |       |       | ing%20adobe%20 | will provide an immediate       |
|   |       |       | acrobat.pdf]() | solution to using electronic    |
|   |       |       |                | signatures with minimum         |
|   |       |       |                | investment and minimal impact   |
|   |       |       |                | on legacy systems. Simply       |
|   |       |       |                | install the adobe acrobat       |
|   |       |       |                | package and use the "PDF        |
|   |       |       |                | Writer" device as your default  |
|   |       |       |                | printer. Whenever a report is   |
|   |       |       |                | printed a file is created       |
|   |       |       |                | containing the report in PDF    |
|   |       |       |                | format. This file can then be   |
|   |       |       |                | viewed and signed using the     |
|   |       |       |                | Acrobat package.                |
+---+-------+-------+----------------+---------------------------------+
| 9 | M     | MAS   | [htt           | The MASTERControl FDA Edition   |
| 4 | aster | TERCo | p://www.master | was developed in 1998 to        |
| . | Co    | ntrol | control.com/fd | address electronic signature    |
|   | ntrol | FDA   | a1.htm](../www | and document security           |
|   | Sys   | Ed    | .mastercontrol | requirements for 21 CFR part 11 |
|   | tems | ition | .com/fda1.htm) | of the FDA GMP. This includes   |
|   |       |       |                | both the enhanced features      |
|   |       |       |                | needed to comply with these     |
|   |       |       |                | standards and assistance with   |
|   |       |       |                | the on-site validation process. |
+---+-------+-------+----------------+---------------------------------+
| 9 | M     | eM    | [www           | The eMatrix 9 platform combines |
| 5 | atrix | atrix | .matrixone.com | an open, flexible Internet      |
| . | One   | 9     | ](http://www.m | platform with extensive         |
|   |       |       | atrixone.com/) | collaboration services, an      |
|   |       |       |                | array of adaptable development  |
|   |       |       |                | tools. The growing collection   |
|   |       |       |                | of software offerings provides  |
|   |       |       |                | proven product lifecycle        |
|   |       |       |                | capabilities - from concept and |
|   |       |       |                | design through manufacture and  |
|   |       |       |                | ongoing service.                |
+---+-------+-------+----------------+---------------------------------+
| 9 | Micr  | Cybe  | [www.mic       | CyberLAB™, is carefully         |
| 6 | omass | rLAB™ | romass.co.uk]( | designed to help you achieve 21 |
| . |       |       | http://www.mic | CFR Part 11 compliance,         |
|   |       |       | romass.co.uk/) | protecting your critical        |
|   |       |       |                | information to the fullest      |
|   |       |       |                | extent possible with features   |
|   |       |       |                | like CyberLAB\'s Electronic     |
|   |       |       |                | Signature plug-in. Utilizing    |
|   |       |       |                | Adobe Acrobat, an               |
|   |       |       |                | industry-standard technology,   |
|   |       |       |                | CyberLAB lets you               |
|   |       |       |                | electronically sign documents,  |
|   |       |       |                | placing an encrypted signature  |
|   |       |       |                | within the document and an      |
|   |       |       |                | unalterable \"watermark\" on    |
|   |       |       |                | the page indicating the         |
|   |       |       |                | signatures validity.            |
+---+-------+-------+----------------+---------------------------------+
| 9 | MIDI  | She   | [www.mi        | The [MIDI Sherlock Microbial    |
| 7 |       | rlock | di-inc.com/pag | Identification System           |
| . |       | 4.0   | es/21cfrII.htm | (MIS)](../products.html) is 21  |
|   |       |       | l](../www.midi | CFR Part 11 compliant. This     |
|   |       |       | -inc.com/pages | software package is called      |
|   |       |       | /21cfrII.html) | Sherlock Electronic Records and |
|   |       |       |                | Signatures (ERS). To help you   |
|   |       |       |                | conform with FDA regulations,   |
|   |       |       |                | the Electronic Records and      |
|   |       |       |                | Signatures package incorporates |
|   |       |       |                | the following features:         |
|   |       |       |                | Preserves ChemStation raw data, |
|   |       |       |                | Sherlock Sequences, and         |
|   |       |       |                | Sherlock Methods associated     |
|   |       |       |                | with a set of analytical runs.  |
|   |       |       |                | Data is stored in a single,     |
|   |       |       |                | secure file that cannot be      |
|   |       |       |                | altered by ordinary means.      |
|   |       |       |                | Files are stored in a location  |
|   |       |       |                | determined by the system        |
|   |       |       |                | administrator. Maintains data   |
|   |       |       |                | integrity such that data can be |
|   |       |       |                | utilized to regenerate the      |
|   |       |       |                | original results. Electronic    |
|   |       |       |                | signature at operational points |
|   |       |       |                | by means of a logon consisting  |
|   |       |       |                | of an operator name and         |
|   |       |       |                | password. Permits review and    |
|   |       |       |                | verification of electronic      |
|   |       |       |                | records through a windows based |
|   |       |       |                | interface. Provides designated  |
|   |       |       |                | personnel with capability to    |
|   |       |       |                | review, approve and             |
|   |       |       |                | electronically sign records.    |
|   |       |       |                | Creates an audit trail of all   |
|   |       |       |                | entries and actions that        |
|   |       |       |                | create, modify or delete an     |
|   |       |       |                | electronic record.              |
+---+-------+-------+----------------+---------------------------------+
| 9 | MiGG  | Qs    | [http://www.   | Qstream iCompliance 4 is a      |
| 8 | Sy    | tream | migg.com/](../ | leading edge development        |
| . | stems | i     | www.migg.com/) | platform for the rapid assembly |
|   |       | Compl |                | of 21 CFR Part 11 compliant web |
|   |       | iance |                | enabled applications providing  |
|   |       | 4     |                | companies within regulated      |
|   |       |       |                | markets a rapid approach to     |
|   |       |       |                | application development that is |
|   |       |       |                | simple to validate.             |
+---+-------+-------+----------------+---------------------------------+
| 9 | NetRe | PQIn  | <http://www.ne | NetRegulus offers product       |
| 9 | gulus | telli | tregulus.com/> | quality intelligence software   |
| . |       | gence |                | and services for FDA regulated  |
|   |       |       |                | medical products organizations. |
|   |       |       |                | Our user-friendly, 21 CFR Part  |
|   |       |       |                | 11 compliant, PQIntelligence™   |
|   |       |       |                | Software System keeps everyone  |
|   |       |       |                | involved in a product\'s life   |
|   |       |       |                | cycle on the same page.         |
|   |       |       |                | PQIntelligence allows firms of  |
|   |       |       |                | all sizes to collect, analyze,  |
|   |       |       |                | report, share, and act on       |
|   |       |       |                | critical regulated data within  |
|   |       |       |                | one streamlined package. Use    |
|   |       |       |                | PQIntelligence for clinical     |
|   |       |       |                | studies management, complaint   |
|   |       |       |                | handling, CAPA management,      |
|   |       |       |                | audit management, and other     |
|   |       |       |                | regulatory needs.               |
+---+-------+-------+----------------+---------------------------------+
| 1 | Ni    | RE    | <http          | RESULT™ Software Provides tools |
| 0 | colet | SULT™ | ://www.nicolet | to comply with 21 CFR Part 11   |
| 0 | Indus |       | industrial.com | Regulations The operation of    |
| . | trial |       | /NISmain.html> | Nicolet Industrial Solutions'   |
|   |       |       |                | analyzers is simplified with    |
|   |       |       |                | its software. RESULT was        |
|   |       |       |                | designed for the specific       |
|   |       |       |                | requirements of process         |
|   |       |       |                | instrumentation. With digital   |
|   |       |       |                | signatures, an audit trail and  |
|   |       |       |                | Logon/Passwords, RESULT helps   |
|   |       |       |                | you meet the requirement of 21  |
|   |       |       |                | CFR Part 11.                    |
+---+-------+-------+----------------+---------------------------------+
| 1 | Not   | Note  | [www.No        | NoteBookMaker™ is a totally     |
| 0 | eBook | BookM | teBookMaker.co | secure, completely electronic   |
| 1 | Maker | aker™ | m](../www.Note | Laboratory Notebook. The first  |
| . |       |       | BookMaker.com) | electronic notebook that looks  |
|   |       |       |                | and prints like a real          |
|   |       |       |                | notebook. This system is easily |
|   |       |       |                | modified and can be custom      |
|   |       |       |                | designed to fit any             |
|   |       |       |                | organization. In fact,          |
|   |       |       |                | NotebookMakerTM meets the       |
|   |       |       |                | requirements of 21 CFR Part 11  |
+---+-------+-------+----------------+---------------------------------+
| 1 | NuGe  | ARC   | <http://www.n  | NuGenesis can be a key part of  |
| 0 | nesis | HIVE® | ugenesis.com/> | your 21 CFR Part 11 compliance  |
| 2 | Te    |       |                | strategy. FDA requirements      |
| . | chnol | U     |                | governing the archiving and     |
|   | ogies | NIFY® |                | retrieval of raw data make it   |
|   | Co    |       |                | essential that companies be     |
|   | rpora | VI    |                | able to provide the original    |
|   | tion. | SION® |                | source data for all electronic  |
|   |       |       |                | records and reports. NuGenesis  |
|   |       |       |                | provides an                     |
|   |       |       |                | application-independent method  |
|   |       |       |                | for storing and cataloging raw  |
|   |       |       |                | laboratory instrument data as   |
|   |       |       |                | well as human readable          |
|   |       |       |                | information from common         |
|   |       |       |                | business applications (such as  |
|   |       |       |                | word processing and spreadsheet |
|   |       |       |                | files). When your analytical    |
|   |       |       |                | reports are online in the       |
|   |       |       |                | NuGenesis database, you can     |
|   |       |       |                | provide auditors with           |
|   |       |       |                | documented evidence back to the |
|   |       |       |                | original source, quickly and    |
|   |       |       |                | easily.                         |
|   |       |       |                |                                 |
|   |       |       |                | NuGenesis Technologies family   |
|   |       |       |                | of products work as an          |
|   |       |       |                | application independent         |
|   |       |       |                | Scientific Data Management      |
|   |       |       |                | System (SDMS) which             |
|   |       |       |                | automatically aggregates data   |
|   |       |       |                | from disparate sources          |
|   |       |       |                | providing greater access and    |
|   |       |       |                | insight into critical knowledge |
|   |       |       |                | generated in the laboratory.    |
|   |       |       |                | These products provide          |
|   |       |       |                | scientists, from the lab to the |
|   |       |       |                | enterprise, unique capabilities |
|   |       |       |                | to enhance the value of         |
|   |       |       |                | information.                    |
+---+-------+-------+----------------+---------------------------------+
| 1 | N     | D     | [www.numoda    | Numoda DataStream wireless      |
| 0 | umoda | ataSt | .com/pages/pro | solution provides clients with  |
| 3 |       | ream™ | ductmed.htm]() | better control over market      |
| . |       |       |                | evaluations and enables the     |
|   |       |       |                | collection and redistribution   |
|   |       |       |                | of error free study data in     |
|   |       |       |                | significantly less time than    |
|   |       |       |                | existing methods. We have       |
|   |       |       |                | delivered this leading          |
|   |       |       |                | technology to some of the       |
|   |       |       |                | world's largest medical device  |
|   |       |       |                | companies. They realize the     |
|   |       |       |                | power, efficiency and           |
|   |       |       |                | simplicity of Numoda DataStrea. |
|   |       |       |                |                                 |
|   |       |       |                | Eliminates time of testing and  |
|   |       |       |                | data entry                      |
|   |       |       |                |                                 |
|   |       |       |                | Greatly reduces paperwork and   |
|   |       |       |                | overall costs                   |
|   |       |       |                |                                 |
|   |       |       |                | Creates a virtually Error-Free  |
|   |       |       |                | Study environment, With point   |
|   |       |       |                | of service data collection and  |
|   |       |       |                | instant distribution            |
|   |       |       |                |                                 |
|   |       |       |                | Provides tailored access to     |
|   |       |       |                | custom reports and workflow     |
|   |       |       |                | logistics                       |
|   |       |       |                |                                 |
|   |       |       |                | Instant, remote updates         |
|   |       |       |                |                                 |
|   |       |       |                | Works with any handheld device  |
|   |       |       |                |                                 |
|   |       |       |                | Secure and validated 21 CFR     |
|   |       |       |                | Part 11 compliant               |
+---+-------+-------+----------------+---------------------------------+
| 1 | OnGA  |       | h              | O.N.G. Automation are the       |
| 0 | utoma |       | ttp://www.onga | official Rockwell Automation    |
| 4 | tion, |       | utomation.com/ | (Allen Bradley) and Foxboro I/A |
| . | Ltd   |       |                | DCS Authorised integrator in    |
|   |       |       |                | Ireland, providing us direct    |
|   |       |       |                | access to the vast range of     |
|   |       |       |                | services and support which is   |
|   |       |       |                | available from both Companies.  |
|   |       |       |                | O.N.G. Automation has proven    |
|   |       |       |                | experience in the               |
|   |       |       |                | implementation of Control       |
|   |       |       |                | Systems from design stage       |
|   |       |       |                | through to final commissioning, |
|   |       |       |                | In the Pharmaceutical,          |
|   |       |       |                | Biochemical, Food, Water and    |
|   |       |       |                | Electricity generation          |
|   |       |       |                | industries. We specialise in    |
|   |       |       |                | GAMP3 and 21 CFR part 11        |
|   |       |       |                | compliant systems.              |
+---+-------+-------+----------------+---------------------------------+
| 1 | Ope   | Liv   | [www.opente    | Open Text's mandate is to       |
| 0 | nText | eLink | xt.com](../www | deploy high-value specific      |
| 5 | Corp. |       | .opentext.com) | implementations of Livelink for |
| . |       |       |                | all areas across the enterprise |
|   |       |       |                | of pharmaceutical companies.    |
|   |       |       |                | Livelink is a collaborative     |
|   |       |       |                | commerce application used for   |
|   |       |       |                | document management, project    |
|   |       |       |                | management and workflow.        |
|   |       |       |                | Livelink is 21-CFR Part 11      |
|   |       |       |                | compliant and integrates with   |
|   |       |       |                | scientific applications and     |
|   |       |       |                | databases.                      |
+---+-------+-------+----------------+---------------------------------+
| 1 | OSI   | PI    | <ht            | OSI Software, Inc. announced    |
| 0 | Soft  | Sy    | tp://www.osiso | new features for its PI System™ |
| 6 | ware, | stem™ | ft.com/osinews | software that allow             |
| . | Inc.  |       | /pressreleases | pharmaceutical customers to     |
|   |       |       | /cfr-pt11.htm> | meet FDA 21 CFR Part 11         |
|   |       |       |                | compliance requirements for     |
|   |       |       |                | storing electronic records. OSI |
|   |       |       |                | Software is the leading         |
|   |       |       |                | provider of real-time           |
|   |       |       |                | information systems for the     |
|   |       |       |                | process industries. Nine of the |
|   |       |       |                | top 10 global pharmaceutical    |
|   |       |       |                | companies currently use the PI  |
|   |       |       |                | System to record and monitor    |
|   |       |       |                | real-time information in their  |
|   |       |       |                | manufacturing and research      |
|   |       |       |                | facilities.                     |
+---+-------+-------+----------------+---------------------------------+
| 1 | Par   | APS   | <http://www.pm | 21 CFR Part 11 Compliant;       |
| 0 | ticle | S-200 | easuring.com/h | Secure System Audit Trails;     |
| 7 | Meas  | Auto  | tml/lauto.htm> | Encrypted Data; Ease of         |
| . | uring | mated |                | Validation; Unique User Names   |
|   | Sys   | Paren |                | And Passwords; Software         |
|   | tems, | teral |                | Validation Notebook             |
|   | Inc.  | Sam   |                |                                 |
|   |       | pling |                |                                 |
|   |       | S     |                |                                 |
|   |       | ystem |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | PENSA | TVM   | [              | We are on the verge of          |
| 0 | Techn | (The  | www.gmps.com/e | launching version 2.0 of TVM    |
| 8 | ology | Valid | xtnews.html]() | that is our own Windows-based   |
| . | Sol   | ation |                | software package offering an    |
|   | ution | Man   |                | expert knowledgebase of         |
|   | Inc.  | ager) |                | compliance and regulatory       |
|   |       |       |                | information to assist with      |
|   |       |       |                | every kind of validation        |
|   |       |       |                | project. Using The Validation   |
|   |       |       |                | Manager can greatly reduce the  |
|   |       |       |                | cost and complexity of managing |
|   |       |       |                | validation projects thanks to   |
|   |       |       |                | the unique use of a             |
|   |       |       |                | Tractability Matrix and         |
|   |       |       |                | OneClick preparation of         |
|   |       |       |                | validation documents. TVM is    |
|   |       |       |                | also designed to be fully       |
|   |       |       |                | compliant with 21 CFR Part 11.  |
+---+-------+-------+----------------+---------------------------------+
| 1 | Perce |       | [www.percepti  | In addition to the standard     |
| 0 | ptive |       | ve.co.uk/Sorce | Sorcerer system, we supply a    |
| 9 | I     |       | rer_UDS.HTM]() | fully validated suite of        |
| . | nstru |       |                | software for UDS which is also  |
|   | ments |       |                | compliant with international    |
|   |       |       |                | GLP's and FDA 21 Part 11.       |
+---+-------+-------+----------------+---------------------------------+
| 1 | P     | Co    | <http://i      | Use CONNECT to transfer data    |
| 1 | erkin | nnect | nstruments.per | between SQL\*LIMS and           |
| 0 | Elmer |       | kinelmer.com/> | Turbochrom. "Unsurpassed        |
| . |       | Turbo |                | GLP/GMP Features Perkin         |
|   |       | chrom |                | Elmer\'s broad range of         |
|   |       |       |                | experience includes providing   |
|   |       |       |                | GLP/GMP data systems since      |
|   |       |       |                | 1980. With Turbochrom           |
|   |       |       |                | Client/Server, the embedded     |
|   |       |       |                | GLP/GMP features provide the    |
|   |       |       |                | most secure and documented data |
|   |       |       |                | handling system ever.           |
|   |       |       |                | Turbochrom Client/Server        |
|   |       |       |                | provides controls for user and  |
|   |       |       |                | instrument access, user         |
|   |       |       |                | configuration of software menus |
|   |       |       |                | and screens, file access,       |
|   |       |       |                | controlled modification of      |
|   |       |       |                | active methods and sequences    |
|   |       |       |                | and more."                      |
+---+-------+-------+----------------+---------------------------------+
| 1 | Phar  | WinN  | [h             | Pharsight is also working with  |
| 1 | sight | onlin | ttp://www.phar | our customers to help them      |
| 1 |       |       | sight.com/](ht | achieve compliance with 21 CFR  |
| . |       | WinN  | tp://www.phars | Part 11 (Electronic Records;    |
|   |       | onMix | ight.com/about | Electronic Signatures; Final    |
|   |       |       | _us/index.htm) | Rule) regulations. The          |
|   |       |       |                | Enterprise Editions of          |
|   |       |       |                | WinNonlin and WinNonMix are     |
|   |       |       |                | initial steps toward achieving  |
|   |       |       |                | this compliance which can be    |
|   |       |       |                | implemented today, allowing     |
|   |       |       |                | users to read PK/PD data and    |
|   |       |       |                | save analysis results directly  |
|   |       |       |                | to/from a secure centralized    |
|   |       |       |                | database protected by user      |
|   |       |       |                | login procedures. Pharsight is  |
|   |       |       |                | also developing a secure        |
|   |       |       |                | repository for PK/PD data and   |
|   |       |       |                | analysis results from           |
|   |       |       |                | WinNonlin, WinNonMix, and other |
|   |       |       |                | analysis tools called the       |
|   |       |       |                | Pharsight Workbench Repository. |
+---+-------+-------+----------------+---------------------------------+
| 1 | Phase | I     | [www.phase     | Phase Forward\'s InForm         |
| 1 | Fo    | nForm | forward.com](h | solution is designed to allow   |
| 2 | rward |       | ttp://www.phas | sponsors to meet with FDA\'s 21 |
| . | In    | InF   | eforward.com/) | CFR Part 11 and can be used in  |
|   | corpo | usion |                | accordance with the FDA\'s      |
|   | rated |       |                | \"Guidance: Computerized        |
|   |       |       |                | Systems Used in Clinical        |
|   |       |       |                | Trials.\" Phase Forward\'s      |
|   |       |       |                | product development team works  |
|   |       |       |                | to meet rigorous GCP quality    |
|   |       |       |                | control standards and conducts  |
|   |       |       |                | regular independent audits      |
|   |       |       |                | using an industry leader in     |
|   |       |       |                | external regulatory quality     |
|   |       |       |                | assurance.                      |
+---+-------+-------+----------------+---------------------------------+
| 1 | PHT   | Ese   | <http:/        | PHT\'s Esendant Clinical        |
| 1 | Corp  | ndant | /www.phtcorp.c | Network fully conforms to CDISC |
| 3 |       | Cli   | om/company/cor | standards                       |
| . |       | nical | psummary.html> | ([www.cdi                       |
|   |       | Ne    |                | sc.org](http://www.cdisc.org/)) |
|   |       | twork |                | and is compliant with FDA 21    |
|   |       |       |                | CFR Part 11.                    |
+---+-------+-------+----------------+---------------------------------+
| 1 | Pi    | Q     | [www.p         | The 21 CFR Part 11 Electronic   |
| 1 | lgrim | &MIS® | ilgrimusa.com] | Signature requirement defines   |
| 4 |       |       | (http://www.pi | the electronic signature as the |
| . |       |       | lgrimusa.com/) | binding signature and is        |
|   |       |       |                | equivalent to that of           |
|   |       |       |                | handwritten signatures, and     |
|   |       |       |                | Pilgrim\'s Electronic Signature |
|   |       |       |                | component provides the          |
|   |       |       |                | necessary controls for each     |
|   |       |       |                | electronic signature to be      |
|   |       |       |                | unique to each individual.      |
+---+-------+-------+----------------+---------------------------------+
| 1 | Pr    | GMP   | [w             | GMPharma is the first e         |
| 1 | icewa | harma | ww.GMPharma.co | business solution jointly       |
| 5 | terho |       | m](http://www. | developed by                    |
| . | useCo |       | GMPharma.com/) | PricewaterhouseCoopers and      |
|   | opers |       |                | Documentum for enterprise wide  |
|   |       |       |                | management of pharmaceutical    |
|   | Docum |       |                | GMP regulated content.          |
|   | entum |       |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | Prin  | A     | [http:         | Princeton Softech's Active      |
| 1 | ceton | ctive | //www.princeto | Archive Solutions™ can assist   |
| 6 | So    | Ar    | nsoftech.com/p | with 21 CFR Part 11 compliance, |
| . | ftech | chive | roducts/21cfr1 | and go well beyond the          |
|   |       | Solut | 1.htm](../www. | traditional definition of       |
|   |       | ions | princetonsofte | archiving to provide additional |
|   |       |       | ch.com/product | benefits. "Active archiving" is |
|   |       |       | s/21cfr11.htm) | unique because it stores        |
|   |       |       |                | research data with 100%         |
|   |       |       |                | accuracy and full relational    |
|   |       |       |                | integrity. This capability      |
|   |       |       |                | makes it easy to browse or      |
|   |       |       |                | research archived data --- even |
|   |       |       |                | generate reports --- without    |
|   |       |       |                | restoring a single row. By      |
|   |       |       |                | safely removing historical      |
|   |       |       |                | research data from production   |
|   |       |       |                | databases, active archiving     |
|   |       |       |                | improves application            |
|   |       |       |                | performance and availability    |
|   |       |       |                | without expensive hardware or   |
|   |       |       |                | software upgrades.              |
+---+-------+-------+----------------+---------------------------------+
| 1 | P     | MAP   | [w             | Prisymedica is the only label   |
| 1 | risym | 80    | ww.map80.co.uk | design and production software  |
| 7 |       |       | /medica.htm]() | that exceeds FDA standars for   |
| . |       | P     |                | compliance, as demanded by the  |
|   |       | risym |                | Pharmaceutical, Clinical Trials |
|   |       | edica |                | and medical device industries.  |
|   |       |       |                |                                 |
|   |       |       |                | Prisymedica, the latest product |
|   |       |       |                | from MAP80, has been            |
|   |       |       |                | specifically introduced to meet |
|   |       |       |                | the requirements of the FDA 21  |
|   |       |       |                | CFR Part 11 rules regarding     |
|   |       |       |                | Electronic Records and          |
|   |       |       |                | Electronic Signatures.          |
+---+-------+-------+----------------+---------------------------------+
| 1 | Pr    |       | [ht            | Process Analysis & Automation   |
| 1 | ocess |       | tp://www.paa.c | Ltd provides state-of-the-art   |
| 8 | Ana   |       | o.uk](http://w | automation and measurement      |
| . | lysis |       | ww.paa.co.uk/) | technology to the               |
|   | &     |       |                | pharmaceutical and chemical     |
|   | Autom |       |                | industries. Custom software and |
|   | ation |       |                | application services. Many      |
|   |       |       |                | products listed as 21 CFR Part  |
|   |       |       |                | 11 compliant.                   |
+---+-------+-------+----------------+---------------------------------+
| 1 | P     | PRO   | [www.proirb.   | PRO_IRB™ is a Microsoft         |
| 1 | roIRB | _IRB™ | com](http://ww | Access-based Institutional      |
| 9 | Plus, |       | w.proirb.com/) | Review Board Software           |
| . | Inc.  |       |                | Application providing           |
|   |       |       |                | productivity and compliance     |
|   |       |       |                | assurance tools for managing    |
|   |       |       |                | the Institutional Review Board  |
|   |       |       |                | process. Agenda preparation,    |
|   |       |       |                | records SAE, manage continuing  |
|   |       |       |                | review. Complies and exceeds    |
|   |       |       |                | 21CFRpart11 requirements where  |
|   |       |       |                | applicable.                     |
+---+-------+-------+----------------+---------------------------------+
| 1 | Pr    | PMX   | [ht            | Propack Data was first          |
| 2 | opack |       | tp://www.propa | established as a company in     |
| 0 | Data  | MES   | ck-data.com](h | 1984. As a pioneer and          |
| . |       |       | ttp://www.prop | visionary in the Manufacturing  |
|   |       | CTM   | ack-data.com/) | Execution System (MES) sector,  |
|   |       |       |                | Propack Data has risen to       |
|   |       | RDM   |                | become the leading supplier for |
|   |       |       |                | the pharmaceuticals industry.   |
|   |       | MQS   |                | Focusing on FDA/GxP-regulated   |
|   |       |       |                | industries such as              |
|   |       |       |                | pharmaceuticals, food-stuffs    |
|   |       |       |                | and cosmetics, Propack Data     |
|   |       |       |                | provides validatable standard   |
|   |       |       |                | software for the entire         |
|   |       |       |                | manufacturing and packaging     |
|   |       |       |                | processes in the field of       |
|   |       |       |                | supply chain execution under an |
|   |       |       |                | ERP system.                     |
|   |       |       |                |                                 |
|   |       |       |                | Propack Data\'s current         |
|   |       |       |                | release, PMX 3.1, satisfies the |
|   |       |       |                | requirements of 21 CFR 11 by    |
|   |       |       |                | tracking the changes within     |
|   |       |       |                | your production documents via   |
|   |       |       |                | audit trails. Additionally,     |
|   |       |       |                | strike the right balance        |
|   |       |       |                | between the amount of data      |
|   |       |       |                | stored and the essential traces |
|   |       |       |                | by trailing only the required   |
|   |       |       |                | attributes of the records.      |
+---+-------+-------+----------------+---------------------------------+
| 1 | Pur   | E-    | [www.pureed    | We offer compliance with FDA    |
| 2 | eEdge | forms | ge.com](../www | 21-CFR-11                       |
| 1 |       |       | .pureedge.com) |                                 |
| . |       |       |                |                                 |
|   |       |       |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | QAD   | MF    | [www.q         | QAD understands patient device  |
| 2 |       | G/Pro | ad.com](http:/ | tracking (PDT), serial          |
| 2 |       |       | /www.qad.com/) | traceability, and validation,   |
| . |       |       |                | and what these conditions mean  |
|   |       |       |                | up and down the business chain, |
|   |       |       |                | from procurement to             |
|   |       |       |                | distribution and all points     |
|   |       |       |                | between.                        |
+---+-------+-------+----------------+---------------------------------+
| 1 | Q-m   | Wond  | <http://www    | Q-mation has developed a set of |
| 2 | ation | erare | .qmation.com/> | Active X controls and script    |
| 3 |       | In    |                | functions that significantly    |
| . |       | touch |                | ease the development of 21 CFR  |
|   |       | A     |                | Part 11 compliant applications  |
|   |       | ctive |                | using Wonderware\'s InTouch 7.x |
|   |       | X     |                | software. These tools help      |
|   |       | Con   |                | address the regulation\'s       |
|   |       | trols |                | requirements around security    |
|   |       |       |                | management, electronic          |
|   |       |       |                | signatures and authority checks |
|   |       |       |                | (i.e. - UserID/Password         |
|   |       |       |                | maintenance, use of Full        |
|   |       |       |                | Printed Name, \"Done by/Checked |
|   |       |       |                | by\" authority checks etc.). In |
|   |       |       |                | addition, we\'ve developed      |
|   |       |       |                | Audit Trail technology that can |
|   |       |       |                | be applied to any Microsoft SQL |
|   |       |       |                | Server database table.          |
+---+-------+-------+----------------+---------------------------------+
| 1 | Qu    | QSI   | [              | Features include multi-level    |
| 2 | ality | S     | www.qualitysys | access security, FDA compliant  |
| 4 | Sy    | ystem | .com](../www.q | electronic signatures, revision |
| . | stems | For   | ualitysys.com) | control and automated document  |
|   | Int   | Doc   |                | status updates. Activities      |
|   | ernat | ument |                | associated with every document  |
|   | ional | Co    |                | are automatically recorded in   |
|   |       | ntrol |                | the history section. Document   |
|   |       |       |                | archiving of approved documents |
|   |       |       |                | is automatic and an optional    |
|   |       |       |                | Draft Documents database        |
|   |       |       |                | automatically provides an audit |
|   |       |       |                | trail that documents            |
|   |       |       |                | time-sequenced development and  |
|   |       |       |                | modification of documents.      |
+---+-------+-------+----------------+---------------------------------+
| 1 | Qumas | DocC  | <http://w      | QUMAS DocCompliance® for        |
| 2 |       | ompli | ww.qumas.com/> | Oracle® is a complete           |
| 5 |       | ance® |                | enterprise compliance           |
| . |       |       |                | application designed            |
|   |       |       |                | exclusively to manage the full  |
|   |       |       |                | lifecycle of regulatory         |
|   |       |       |                | controlled documentation.       |
|   |       |       |                | Organizations are assured of    |
|   |       |       |                | compliance with regulatory      |
|   |       |       |                | bodies\' guidelines and         |
|   |       |       |                | directives (including the       |
|   |       |       |                | FDA\'s Final Ruling on          |
|   |       |       |                | Electronic Signature CFR 21     |
|   |       |       |                | Part 11). The risk of           |
|   |       |       |                | non-conformance is avoided      |
|   |       |       |                | through complete auditing and   |
|   |       |       |                | traceability on document        |
|   |       |       |                | history including event logs,   |
|   |       |       |                | audit trails and comprehensive  |
|   |       |       |                | reports.                        |
+---+-------+-------+----------------+---------------------------------+
| 1 | R     | Argus | http://www.r   | Argus Safety ™ Features:        |
| 2 | elsys | S     | elsys-inc.com/ |                                 |
| 6 |       | afety |                | 21 CFR Part 11 Compliant        |
| . |       | ™     |                |                                 |
|   |       |       |                | ICH E2B - Electronic Submission |
|   |       | Eas   |                |                                 |
|   |       | yTrak |                | ICH E2C - PSUR                  |
|   |       | ™     |                |                                 |
|   |       |       |                | Compliant with current MedDRA™  |
|   |       |       |                | versions                        |
|   |       |       |                |                                 |
|   |       |       |                | CIOMS V                         |
|   |       |       |                |                                 |
|   |       |       |                | EasyTrak ™ Features:            |
|   |       |       |                |                                 |
|   |       |       |                | 21 CFR Part 11 Compliant        |
|   |       |       |                |                                 |
|   |       |       |                | Meets FDA complaint handling    |
|   |       |       |                | requirements                    |
|   |       |       |                |                                 |
|   |       |       |                | Integrated adverse-event        |
|   |       |       |                | reporting for FDA and EU Device |
|   |       |       |                | Vigilance Reporting             |
|   |       |       |                |                                 |
|   |       |       |                | Return Goods Authorization      |
|   |       |       |                |                                 |
|   |       |       |                | Alternate Summary Report        |
+---+-------+-------+----------------+---------------------------------+
| 1 | Rev   | Revel | [http:         | Revelink has developed a        |
| 2 | elink | ink's | //www.revelink | validated enterprise            |
| 7 |       | Enter | .com/](../www. | application development         |
| . |       | prise | revelink.com/) | platform that enables           |
|   |       | Exec  |                | developers serving regulated    |
|   |       | utive |                | industries to build enterprise  |
|   |       |       |                | applications in 10% of the time |
|   |       |       |                | currently required to design    |
|   |       |       |                | and develop using typical       |
|   |       |       |                | application development         |
|   |       |       |                | methodologies. Building with    |
|   |       |       |                | Revelink's Enterprise Executive |
|   |       |       |                | results in Enterprise           |
|   |       |       |                | Applications that are robust &  |
|   |       |       |                | scalable; are based on open     |
|   |       |       |                | software standards; use common  |
|   |       |       |                | enterprise repositories; and    |
|   |       |       |                | are 21CFR11 compliant.          |
+---+-------+-------+----------------+---------------------------------+
| 1 | Roc   | RSVi  | <http:/        | Rockwell Automation has         |
| 2 | kwell | ew32™ | /support.softw | announced that its flagship HMI |
| 8 | Autom |       | are.rockwell.c | products, RSView32™ and         |
| . | ation |       | om/consulting> | RSView32 Active Display         |
|   |       |       |                | System™, fully support the      |
|   |       |       |                | development of projects and     |
|   |       |       |                | systems that comply with FDA    |
|   |       |       |                | (Food and Drug Administration)  |
|   |       |       |                | Title 21 - Code of Federal      |
|   |       |       |                | Regulations - Part 11 (21 CFR   |
|   |       |       |                | Part 11) regulations.           |
+---+-------+-------+----------------+---------------------------------+
| 1 | SAI   | S     | [              | Software Associates             |
| 2 |       | ample | www.sai.com]() | International,® LLC (SAI), is a |
| 9 |       | Gua   |                | leading provider of innovative  |
| . |       | rdian |                | and practical                   |
|   |       |       |                | information-processing          |
|   |       |       |                | solutions that meet the         |
|   |       |       |                | specific sales and marketing    |
|   |       |       |                | needs of the Life Sciences      |
|   |       |       |                | industry. SAI has demonstrated  |
|   |       |       |                | the existence of adequate       |
|   |       |       |                | procedures and controls within  |
|   |       |       |                | Sample Guardian™, which are     |
|   |       |       |                | designed to ensure the          |
|   |       |       |                | authenticity and integrity of   |
|   |       |       |                | electronic records utilized to  |
|   |       |       |                | meet requirements of the PDMA.  |
|   |       |       |                | In addition, SAI implements     |
|   |       |       |                | extensive documentation         |
|   |       |       |                | outlining their processes and   |
|   |       |       |                | procedures. It is PDMA, Inc.\'s |
|   |       |       |                | regulatory opinion that Sample  |
|   |       |       |                | Guardian complies with the      |
|   |       |       |                | requirements 21 CFR Part 11     |
|   |       |       |                | pertaining to closed systems.   |
+---+-------+-------+----------------+---------------------------------+
| 1 | SAP   | cGMP  | [www.s         | Create of EBR after final       |
| 3 |       | Regu  | ap.com](http:/ | completion of Production order, |
| 0 |       | lated | /www.sap.com/) | using documentation of process  |
| . |       | Man   |                | as well as of results of the    |
|   |       | ufact |                | process, including staged and   |
|   |       | uring |                | identified Materials and        |
|   |       | M     |                | reconciled material             |
|   |       | odule |                | consumptions, EBR approval can  |
|   |       |       |                | be made mandatory for usage     |
|   |       |       |                | decision. EBR will be saved     |
|   |       |       |                | with version number as          |
|   |       |       |                | non-editable ( PDF) file.       |
|   |       |       |                | Future updates of the EBR will  |
|   |       |       |                | require a new version number.   |
|   |       |       |                | Stored EBR can be retrieved,    |
|   |       |       |                | viewed and printed as           |
|   |       |       |                | necessary. Full support for 21  |
|   |       |       |                | CFR Part 11 signature and       |
|   |       |       |                | record requirements.            |
+---+-------+-------+----------------+---------------------------------+
| 1 | Scien | EZ    | <http://w      | Manufacturer of EZ Chrom Elite  |
| 3 | tific | Chrom | ww.scisw.com/> | v2.7 chromatography data        |
| 1 | Soft  | Elite |                | system.                         |
| . | ware, |       |                |                                 |
|   | Inc.  |       |                | EZChrom Elite fully complies    |
|   |       |       |                | with 21 CFR Part 11 Electronic  |
|   |       |       |                | Signature requirements. In      |
|   |       |       |                | addition to the display of      |
|   |       |       |                | electronic signatures on the    |
|   |       |       |                | report, the signature           |
|   |       |       |                | information (Who, When, and     |
|   |       |       |                | Why) is stored within the data  |
|   |       |       |                | file with a CRC checksum to     |
|   |       |       |                | prevent tampering with the      |
|   |       |       |                | signature record. This          |
|   |       |       |                | information is also logged in   |
|   |       |       |                | the data file audit trail.      |
+---+-------+-------+----------------+---------------------------------+
| 1 | Shi   | Class | [w             | Supplier of Chromatography and  |
| 3 | madzu | VP    | ww.shimadzu.co | analytical equipment, 21 CFR    |
| 2 |       |       | m](http://www. | Part 11 is not specifically     |
| . |       |       | shimadzu.com/) | identified, but their sales     |
|   |       |       |                | brochures make it sound like    |
|   |       |       |                | the raw data files can be       |
|   |       |       |                | archived by VP Archive software |
|   |       |       |                | if acquired on either Lab       |
|   |       |       |                | Solutions (GC) software or      |
|   |       |       |                | Class VP (HPLC) software        |
|   |       |       |                | interfaced with Shimadzu        |
|   |       |       |                | equipment                       |
+---+-------+-------+----------------+---------------------------------+
| 1 | Si    | ERB   | [www.sea.si    | Siemens began laying the        |
| 3 | emens |       | emens.com/chem | foundation for FDA 21 CFR part  |
| 3 |       |       | phar/newsprod/ | 11 compliant control systems    |
| . |       |       | cpelerec.html] | early in 1995 before the FDA    |
|   |       |       | (../www.sea.si | made its final ruling. Based on |
|   |       |       | emens.com/chem | the 1994 proposed ruling and    |
|   |       |       | phar/newsprod/ | user input from major           |
|   |       |       | cpelerec.html) | pharmaceutical customers all    |
|   |       |       |                | the major groundwork had        |
|   |       |       |                | already been completed by       |
|   |       |       |                | August of 1997 when the FDA     |
|   |       |       |                | ruled on electronic records and |
|   |       |       |                | electronic signatures with 21   |
|   |       |       |                | CFR Part 11. Only minor         |
|   |       |       |                | modifications were needed to    |
|   |       |       |                | meet the final ruling. Since    |
|   |       |       |                | that time Siemens has continued |
|   |       |       |                | to lead the competition in 21   |
|   |       |       |                | CFR Part 11 with numerous       |
|   |       |       |                | installations in the            |
|   |       |       |                | pharmaceutical industries.      |
|   |       |       |                | Those installations include the |
|   |       |       |                | creation of one of the first    |
|   |       |       |                | paperless pharmaceutical        |
|   |       |       |                | manufacturing facilities        |
|   |       |       |                | specifically designed to meet   |
|   |       |       |                | the requirements of 21 CFR Part |
|   |       |       |                | 11.                             |
+---+-------+-------+----------------+---------------------------------+
| 1 | Si    | Appr  | [http:/        | Meets FDA 21 CFR Part 11 right  |
| 3 | lanis | oveIT | /www.silanis.c | out of the box ApproveIt from   |
| 4 | Techn |       | om](http://www | Silanis moves signature         |
| . | ology |       | .silanis.com/) | approvals on-line without       |
|   |       |       |                | additional hardware, software   |
|   |       |       |                | or programming. Its native      |
|   |       |       |                | support for the most widely     |
|   |       |       |                | used document creation tools    |
|   |       |       |                | leverages your organization\'s  |
|   |       |       |                | existing communications         |
|   |       |       |                | infrastructure so you can       |
|   |       |       |                | continue doing business as      |
|   |       |       |                | usual, with little or no        |
|   |       |       |                | additional training             |
+---+-------+-------+----------------+---------------------------------+
| 1 | Sma   | Sma   | [http:         | SmarTeam Corporation's SmarTeam |
| 3 | rTeam | rTeam | //www.smarteam | for the FDA solution provides   |
| 5 |       | for   | .com/main.asp? | your company with a much-needed |
| . |       | the   | fLang=2&fLevel | competitive advantage: instant  |
|   |       | FDA   | OneIdSubject=1 | compliance with the technical   |
|   |       | kit   | 51&fLevelTwoId | requirements of FDA Regulation  |
|   |       |       | Subject=445&fL | Rule 21 CFR Part 11 and         |
|   |       |       | evelThreeIdSub | facilitating compliance with    |
|   |       |       | ject=5346&fLev | the procedural control          |
|   |       |       | elFourthIdSubj | requirments.                    |
|   |       |       | ect=&fId=5346& |                                 |
|   |       |       | fLangName=eng& |                                 |
|   |       |       | fCurrentLevel= |                                 |
|   |       |       | 3&fItemDocType |                                 |
|   |       |       | =1&fActionMain |                                 |
|   |       |       | =&fDocId=&Pare |                                 |
|   |       |       | ntId=445&fDocI |                                 |
|   |       |       | dTraining=&res |                                 |
|   |       |       | olus](../www.s |                                 |
|   |       |       | marteam.com/ma |                                 |
|   |       |       | in.asp%3FfLang |                                 |
|   |       |       | =2&fLevelOneId |                                 |
|   |       |       | Subject=151&fL |                                 |
|   |       |       | evelTwoIdSubje |                                 |
|   |       |       | ct=445&fLevelT |                                 |
|   |       |       | hreeIdSubject= |                                 |
|   |       |       | 5346&fLevelFou |                                 |
|   |       |       | rthIdSubject=& |                                 |
|   |       |       | fId=5346&fLang |                                 |
|   |       |       | Name=eng&fCurr |                                 |
|   |       |       | entLevel=3&fIt |                                 |
|   |       |       | emDocType=1&fA |                                 |
|   |       |       | ctionMain=&fDo |                                 |
|   |       |       | cId=&ParentId= |                                 |
|   |       |       | 445&fDocIdTrai |                                 |
|   |       |       | ning=&resolus) |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | Sof   | ISO   | [www.i         | ISOtrain is a compliance driven |
| 3 | teck, | Train | sotrain.com]() | training management software    |
| 6 | Inc.  |       |                | that meets government           |
| . |       |       |                | regulations, ISO 9000 standards |
|   |       |       |                | and comprehensive validation    |
|   |       |       |                | protocols for a total quality   |
|   |       |       |                | based training. It has been     |
|   |       |       |                | developed based on industry     |
|   |       |       |                | reactions to government         |
|   |       |       |                | inspection observations (FDA,   |
|   |       |       |                | OSHA, EPA, etc.), 483\'s        |
|   |       |       |                | citations, and current or       |
|   |       |       |                | future client\'s requirements.  |
|   |       |       |                |                                 |
|   |       |       |                | Yes, ISOtrain is 21 CFR Part 11 |
|   |       |       |                | compliant!                      |
+---+-------+-------+----------------+---------------------------------+
| 1 | Sof   |       | [htt           | Software House Enterprise       |
| 3 | tware |       | p://www.shes.c | Solutions has years of          |
| 7 | House |       | om/web/SHESWeb | experience building software    |
| . | Enter |       | .nsf/LUvwAllPa | solutions for the               |
|   | prise |       | ges/Software+S | pharmaceutical industry. Some   |
|   | Solu  |       | olutions?OpenD | of our systems have been        |
|   | tions |       | ocument&Topic= | validated, and all of our work  |
|   |       |       | 7&SubTopic=0]( | is done according to the high   |
|   |       |       | ../www.shes.co | standards maintained in this    |
|   |       |       | m/web/SHESWeb. | demanding, regulated            |
|   |       |       | nsf/LUvwAllPag | environment. Based on our own   |
|   |       |       | es/Software+So | internal SOP\'s, our systems    |
|   |       |       | lutions%3FOpen | are built to comply with        |
|   |       |       | Document&Topic | 21CFR11 (when required), with   |
|   |       |       | =7&SubTopic=0) | full implementation of          |
|   |       |       |                | electronic signatures.          |
+---+-------+-------+----------------+---------------------------------+
| 1 | Sotax | Win   | <http://w      | SOTAX is the technology leader  |
| 3 | AG    | SOTAX | ww.sotax.com/> | in the development and          |
| 8 |       |       |                | manufacture of Instruments for  |
| . |       |       |                | tablet Dissolution Testing for  |
|   |       |       |                | over 25 Years. WinSOTAX is a    |
|   |       |       |                | modular and configurable        |
|   |       |       |                | software package to collect     |
|   |       |       |                | data from various laboratory    |
|   |       |       |                | instruments, to store this data |
|   |       |       |                | in a database, to retrieve it   |
|   |       |       |                | for analysis, monitoring and    |
|   |       |       |                | report generation. From the     |
|   |       |       |                | beginning the package has been  |
|   |       |       |                | developed following the rules   |
|   |       |       |                | of GLP, GALP and the GAMP       |
|   |       |       |                | guidelines. It therefore        |
|   |       |       |                | matches the requirements of 21  |
|   |       |       |                | CFR Part 11 with few exceptions |
|   |       |       |                | by design. The next upgrades    |
|   |       |       |                | will address the remaining 3    |
|   |       |       |                | issues.                         |
+---+-------+-------+----------------+---------------------------------+
| 1 | S     | Trac  | [www.sparta-sy | Sparta Systems\' TrackWise is a |
| 3 | parta | kWise | stems.com](htt | powerful system for tracking    |
| 9 | Sys   |       | p://www.sparta | and managing:                   |
| . | tems, |       | -systems.com/) |                                 |
|   | Inc.  |       |                | -   Problem Reports             |
|   |       |       |                |                                 |
|   |       |       |                | -   Bugs/Defects                |
|   |       |       |                |                                 |
|   |       |       |                | -   Change Requests             |
|   |       |       |                |                                 |
|   |       |       |                | -   Customer Complaints         |
|   |       |       |                |                                 |
|   |       |       |                | -   Corrective Action Items     |
|   |       |       |                |                                 |
|   |       |       |                | -   Investigation Reports       |
|   |       |       |                |                                 |
|   |       |       |                | -   Audit Observations/Findings |
|   |       |       |                |                                 |
|   |       |       |                | TrackWise software is fully     |
|   |       |       |                | equipped with electronic        |
|   |       |       |                | signature to comply with CFR 21 |
|   |       |       |                | Part 11.                        |
+---+-------+-------+----------------+---------------------------------+
| 1 | St    | Compl | [http          | We have developed               |
| 4 | elex, | iance | ://www.stelex. | ComplianceBuilder: The          |
| 0 | Inc.  | Bu    | com](http://ww |                                 |
| . |       | ilder | w.stelex.com/) | Turnkey Part 11 Compliance      |
|   |       |       |                | Solution, which has been        |
|   |       |       |                | designed for FDA                |
|   |       |       |                |                                 |
|   |       |       |                | Regulated environments to bring |
|   |       |       |                | their existing or legacy data   |
|   |       |       |                |                                 |
|   |       |       |                | collection systems into 21 CFR  |
|   |       |       |                | § 11 compliance. This turnkey   |
|   |       |       |                | solution                        |
|   |       |       |                |                                 |
|   |       |       |                | integrates seamlessly and       |
|   |       |       |                | quickly into existing topology  |
|   |       |       |                | and is                          |
|   |       |       |                |                                 |
|   |       |       |                | delivered with all required     |
|   |       |       |                | software, validation documents  |
|   |       |       |                | and                             |
|   |       |       |                |                                 |
|   |       |       |                | services.                       |
+---+-------+-------+----------------+---------------------------------+
| 1 | Syc   | Mobil | [www.thesycamo | The Sycamore Group is helping   |
| 4 | amore | Data  | regroup.com]() | companies comply with 21 CFR    |
| 1 | G     | A     |                | Part 11 through Mobil Data      |
| . | roup, | cquis |                | Acquisition. Mobile wireless    |
|   | The   | ition |                | data capture technology         |
|   |       |       |                | provides Environmental          |
|   |       |       |                | Monitoring departments the      |
|   |       |       |                | capability to improve quality   |
|   |       |       |                | and productivity issues. Mobile |
|   |       |       |                | wireless devices provide        |
|   |       |       |                | laboratory technicians          |
|   |       |       |                | immediate and real-time access  |
|   |       |       |                | to environmental data systems   |
|   |       |       |                | while meeting regulatory        |
|   |       |       |                | compliance standards. The       |
|   |       |       |                | real-time communication         |
|   |       |       |                | eliminates redundant data entry |
|   |       |       |                | time, reduces the need for      |
|   |       |       |                | redundant testing, ensures data |
|   |       |       |                | integrity and ultimately        |
|   |       |       |                | increases productivity          |
+---+-------+-------+----------------+---------------------------------+
| 1 | Symfo | S     | [www.          | The Symfo is a portable,        |
| 4 |       | ympho | symfo.com](../ | one-hand operable, electronic   |
| 2 |       | V3/V4 | www.symfo.com) | patient diary capable of        |
| . |       |       |                | recording patient data in REAL  |
|   |       |       |                | TIME. This secure data          |
|   |       |       |                | transmission will provide a     |
|   |       |       |                | better follow-up of the patient |
|   |       |       |                | without making a contact        |
|   |       |       |                | between the patient and the     |
|   |       |       |                | investigator necessary. At the  |
|   |       |       |                | end of the trial, the patient   |
|   |       |       |                | will return the Symfo to the    |
|   |       |       |                | investigator/CRO who will       |
|   |       |       |                | download the recorded           |
|   |       |       |                | parameters onto a computer      |
|   |       |       |                | (xls, sas or any other file).   |
|   |       |       |                | The system has been developed   |
|   |       |       |                | and is produced according to    |
|   |       |       |                | the strict ISO 9001 procedures. |
|   |       |       |                | The system is FDA Part 11       |
|   |       |       |                | Compliant.                      |
+---+-------+-------+----------------+---------------------------------+
| 1 | Ta    | TeC   | [www.taratec.c | TeC, Taratec's e-Compliance     |
| 4 | ratec |       | om](http://www | Solution, will help ensure      |
| 3 |       |       | .taratec.com/) | compliance for computer systems |
| . |       |       |                | used in all phases of the       |
|   |       |       |                | product development cycle.      |
+---+-------+-------+----------------+---------------------------------+
| 1 | T     | TO    | [w             | TOCTalk Version 3.5 combined    |
| 4 | ekmar | CTalk | ww.tekmar.com] | with the reliable,              |
| 4 | Doh   | Ve    | (../www.tekmar | high-throughput Phoenix 8000    |
| . | rmann | rsion | .com%20/produc | TOC Analyzer is the ideal       |
|   |       | 3.5   | ts/toc/21cfr/) | solution for today\'s           |
|   |       |       |                | Pharmaceutical water for        |
|   |       | For   |                | injection (WFI) and clean in    |
|   |       | Ph    |                | place (CIP) applications.       |
|   |       | oenix |                |                                 |
|   |       | 8000  |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | T     | Pro   | [htt           | Provides compliance with        |
| 4 | enrox | jeca™ | p://www.tenrox | government and regulatory       |
| 5 |       |       | .com/en/indust | regulations such as FDA 21 CFR  |
| . |       |       | ry_solutions/p | Part 11                         |
|   |       |       | harma_bio.htm] |                                 |
|   |       |       | (../www.tenrox |                                 |
|   |       |       | .com/en/indust |                                 |
|   |       |       | ry_solutions/p |                                 |
|   |       |       | harma_bio.htm) |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | Ther  | G     | [h             | Thermo Galactic\'s latest       |
| 4 | moGal | RAMS/ | ttp://www.gala | version of its popular          |
| 6 | actic | AI    | ctic.com/produ | spectroscopy data processing    |
| . |       | ve    | cts/pdfs/GRAMS | software, GRAMS/AI provides     |
|   |       | rsion | AI7.pdf](../ww | tools to help laboratories      |
|   |       | 7     | w.galactic.com | handle data in a way that is    |
|   |       |       | /products/pdfs | compliant with 21 CFR Part 11.  |
|   |       |       | /GRAMSAI7.pdf) |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | T     | Nau   | <http://www.la | Thermo LabSystems has been      |
| 4 | hermo | tilus | bsystems.com/> | successfully developing and     |
| 7 | LabSy |       |                | supporting Chromatography Data  |
| . | stems | Atlas |                | Systems (CDS) since the early   |
|   |       |       |                | 1980\'s.                        |
|   |       |       |                |                                 |
|   |       |       |                | Atlas™ is our latest generation |
|   |       |       |                | solution. The recent ruling by  |
|   |       |       |                | the US Food & Drug              |
|   |       |       |                | Administration on electronic    |
|   |       |       |                | records and signatures (21 CFR  |
|   |       |       |                | Part 11) has impacted upon      |
|   |       |       |                | chromatographers. **Atlas**     |
|   |       |       |                | facilitates full compliance     |
|   |       |       |                | with this ruling and is         |
|   |       |       |                | relieving much of the burden    |
|   |       |       |                | faced by our regulated          |
|   |       |       |                | customers and, therefore,       |
|   |       |       |                | assisting in achieving a        |
|   |       |       |                | validated CDS solution.         |
|   |       |       |                |                                 |
|   |       |       |                | **Nautilus** sets the standard  |
|   |       |       |                | in delivering LIMS              |
|   |       |       |                | functionality into the          |
|   |       |       |                | laboratory. Nautilus includes   |
|   |       |       |                | assisting customers in          |
|   |       |       |                | complying with the FDA ruling   |
|   |       |       |                | on electronic records and       |
|   |       |       |                | signatures (21 CFR part 11).    |
|   |       |       |                | Nautilus can also play a        |
|   |       |       |                | compliance role in              |
|   |       |       |                | organizations certified to      |
|   |       |       |                | ISO9001 standards.              |
+---+-------+-------+----------------+---------------------------------+
| 1 | T     | OMNIC | <http://ww     | Document at                     |
| 4 | hermo |       | w.thermonicole | <http://www.nic                 |
| 8 | Ni    |       | t.com/labsys/> | olet.com/labsys/pdf/21cfr1.pdf> |
| . | colet |       |                | explains how OMNIC 6.0 and      |
|   |       |       |                | higher is part 11 compliant.    |
+---+-------+-------+----------------+---------------------------------+
| 1 | T     | Inspe | [http:/www     | TISCOR designs software for     |
| 4 | iscor | ction | .TISCOR.com]() | hand-held computers for         |
| 9 |       | Ma    |                | technicians performing site and |
| . |       | nager |                | equipment inspections.          |
|   |       |       |                | Technicians use small,          |
|   |       |       |                | hand-held computers to scan     |
|   |       |       |                | barcodes placed at various      |
|   |       |       |                | checkpoints requiring           |
|   |       |       |                | inspections by regulatory       |
|   |       |       |                | agencies. TISCOR solutions      |
|   |       |       |                | prove compliance and prevent    |
|   |       |       |                | the falsifying of records.      |
|   |       |       |                | Among TISCOR\'s many products   |
|   |       |       |                | is Inspection Manager, which    |
|   |       |       |                | effectively addresses 21CFR     |
|   |       |       |                | Part 11                         |
+---+-------+-------+----------------+---------------------------------+
| 1 | V     | ICPE  | [www.va        | Varian, Inc. understands the    |
| 5 | arian | xpert | rianinc.com]() | importance of providing         |
| 0 |       |       |                | software tools for its          |
| . |       |       |                | customers that facilitate their |
|   |       |       |                | compliance with US FDA          |
|   |       |       |                | regulations. Varian's           |
|   |       |       |                | instrument control software     |
|   |       |       |                | provides its customers with a   |
|   |       |       |                | robust, reliable platform that  |
|   |       |       |                | continues to evolve to meet     |
|   |       |       |                | their changing requirements. In |
|   |       |       |                | continuing with this            |
|   |       |       |                | commitment, it is Varian's      |
|   |       |       |                | intention to provide software   |
|   |       |       |                | for selected Optical            |
|   |       |       |                | Spectroscopy Instruments to     |
|   |       |       |                | help its customers meet the     |
|   |       |       |                | requirements of the FDA         |
|   |       |       |                | Electronic Records and          |
|   |       |       |                | Electronic Signatures Rule (21  |
|   |       |       |                | CFR Part 11).                   |
+---+-------+-------+----------------+---------------------------------+
| 1 | V     | InfoW | [www.v         | Vector Corporation provides a   |
| 5 | ector | izard | ectorcorporati | full range of control systems   |
| 1 | C     |       | on.com](http:/ | for the operation of the Fluid  |
| . | orpor |       | /www.vectorcor | Bed, Hi-Coaters, Roller         |
|   | ation |       | poration.com/) | Compactors, High Shear mixer    |
|   |       |       |                | granulators, and the Rotary     |
|   |       |       |                | Presses. Vector\'s InfoWizard   |
|   |       |       |                | is now fully FDA 21 CFR Part 11 |
|   |       |       |                | Compliant! Vector InfoWizard is |
|   |       |       |                | a tool to allow the operator to |
|   |       |       |                | perform various functions       |
|   |       |       |                | pertaining to the batch         |
|   |       |       |                | information. There is no need   |
|   |       |       |                | to search all over the system   |
|   |       |       |                | to get the necessary            |
|   |       |       |                | information.                    |
+---+-------+-------+----------------+---------------------------------+
| 1 | Vel   | ePMC  | <http://www.   | VelQuest\'s ePMC solution       |
| 5 | Quest |       | velquest.com/> | acquires data electronically at |
| 2 | Corp  |       |                | its source, links the data to   |
| . |       |       |                | analytical test procedures,     |
|   |       |       |                | secures the data and provides a |
|   |       |       |                | platform for a wide range of IT |
|   |       |       |                | applications. Furthermore, the  |
|   |       |       |                | VelQuest ePMC solution provides |
|   |       |       |                | a means to meet recent FDA      |
|   |       |       |                | regulations, specifically 21    |
|   |       |       |                | CFR Part 11, governing the use  |
|   |       |       |                | of electronic records and       |
|   |       |       |                | signatures in regulated         |
|   |       |       |                | laboratories.                   |
+---+-------+-------+----------------+---------------------------------+
| 1 | Ve    | VLog  | [http://ww     | Completely tamper-proof,        |
| 5 | riteq | Sof   | w.veriteq.com/ | password-protected and secure,  |
| 3 |       | tware | html/vrtq2800. | VL-series data loggers and      |
| . |       |       | htm](../www.ve | [vLog                           |
|   |       |       | riteq.com/html | Software](../vrtq2800vlog.htm)  |
|   |       |       | /vrtq2800.htm) | produce traceable high-accuracy |
|   |       |       |                | documentation that meets the    |
|   |       |       |                | electronic record requirements  |
|   |       |       |                | of 21 CFR Part 11.              |
+---+-------+-------+----------------+---------------------------------+
| 1 | V     | S     | [http://ww     | 21 CFR Part 11 (FDA) - Secure   |
| 5 | isual | ecure | w.visualautoma | Desktop has several features to |
| 4 | Autom | De    | tion.com/compr | aid the pharmaceutical,         |
| . | ation | sktop | od/](../www.vi | biotechnology, food, and        |
|   |       | 5     | sualautomation | beverage industries. Using      |
|   |       |       | .com/comprod/) | Secure Desktop, program and     |
|   |       |       |                | data access can be controlled,  |
|   |       |       |                | user activity can be logged to  |
|   |       |       |                | disk, and users can be          |
|   |       |       |                | automatically logged off from   |
|   |       |       |                | Windows NT 4.0 or 2000 due to   |
|   |       |       |                | inactivity.                     |
+---+-------+-------+----------------+---------------------------------+
| 1 | W     | Mille | [www.waters.   | Millennium 32 Chromatography    |
| 5 | aters | nnium | com](http://ww | data system. The first major    |
| 5 | Corp. | 32    | w.waters.com/) | version of the company\'s       |
| . |       |       |                | chromatography software adds    |
|   |       |       |                | complete 21 CFR Part 11         |
|   |       |       |                | compliance, dual-tower control, |
|   |       |       |                | and data acquisition support    |
|   |       |       |                | for Agilent 5890 and 6890 gas   |
|   |       |       |                | chromatographs and the Waters   |
|   |       |       |                | Alliance dissolution system,    |
|   |       |       |                | pattern recognition algorithms  |
|   |       |       |                | for chromatogram comparisons,   |
|   |       |       |                | and full support of Microsoft   |
|   |       |       |                | Windows web standards; an Open  |
|   |       |       |                | Access option builds in routine |
|   |       |       |                | operating features for          |
|   |       |       |                | technicians who are not experts |
|   |       |       |                | in the company\'s software.     |
+---+-------+-------+----------------+---------------------------------+
| 1 | Werum | PAS-X | <http://w      | Werum supplies perfect          |
| 5 |       | MES   | ww.werum.com/> | technical MES (Manufacturing    |
| 6 |       |       |                | Execution Systems) solutions    |
| . |       |       |                | and services for the GxP/FDA    |
|   |       |       |                | related pharmaceutical industry |
|   |       |       |                | in compliance with 21 CFR 11.   |
|   |       |       |                | The standard PAS-X MES product  |
|   |       |       |                | range provides easy             |
|   |       |       |                | qualification and validation.   |
|   |       |       |                | PAS-X supports a rich set of    |
|   |       |       |                | features that help to           |
|   |       |       |                | streamline the whole            |
|   |       |       |                | pharmaceutical production       |
|   |       |       |                | process e.g. Electronic Batch   |
|   |       |       |                | Recording/EBR.                  |
+---+-------+-------+----------------+---------------------------------+
| 1 | W     | Data  | <ht            | Wimmer Systems has developed    |
| 5 | immer | Compl | tp://www.wimme | the Data Compliance System™ for |
| 7 | Sys   | iance | rsystems.com/> | Microsoft Excel®. Many          |
| . | tems, | Sy    |                | organizations working towards   |
|   | LLC   | stem™ |                | full compliance with the        |
|   |       |       |                | requirements of 21 CFR Part 11  |
|   |       |       |                | still rely on Excel for their   |
|   |       |       |                | data processing needs. DaCS     |
|   |       |       |                | provides a simple,              |
|   |       |       |                | cost-effective solution that    |
|   |       |       |                | allows for continued use of     |
|   |       |       |                | Excel in such an environment.   |
+---+-------+-------+----------------+---------------------------------+
| 1 | Wonde | In    | [www.won       | InBatch has been designed to    |
| 5 | rware | Batch | derware.com]() | meet the requirements of even   |
| 8 |       |       |                | the most regulated industries.  |
| . |       |       |                | InBatch is100% compliant with   |
|   |       |       |                | the United States Food and Drug |
|   |       |       |                | Administration (FDA) final      |
|   |       |       |                | ruling on Electronic Records    |
|   |       |       |                | and Electronic Signatures       |
|   |       |       |                | referred to as 21CFR Part 11.   |
+---+-------+-------+----------------+---------------------------------+
| 1 | Xcert | S     | <http://w      | Sentry CA provides a            |
| 5 |       | entry | ww.xcert.com/> | certificate issuance and        |
| 9 |       | CA    |                | management solution that        |
| . |       |       |                | enables global Public Key       |
|   |       | S     |                | Infrastructure (PKI).           |
|   |       | entry |                |                                 |
|   |       | RA    |                | The US Food and Drug            |
|   |       |       |                | Administration (FDA) has        |
|   |       |       |                | outlined requirements for the   |
|   |       |       |                | pharmaceutical industry         |
|   |       |       |                | regarding the use of electronic |
|   |       |       |                | records and electronic          |
|   |       |       |                | signatures through their 21 CFR |
|   |       |       |                | Part 11 regulations. Xcert      |
|   |       |       |                | Sentry allows pharmaceutical    |
|   |       |       |                | companies to meet these         |
|   |       |       |                | regulations and take advantage  |
|   |       |       |                | of the cost savings and         |
|   |       |       |                | conveniences that e-business    |
|   |       |       |                | brings.                         |
+---+-------+-------+----------------+---------------------------------+
| 1 | Z     | Ta    | [www           | The Zolera Tamarin Integrity    |
| 6 | olera | marin | .zolera.com]() | Server protects critical        |
| 0 | Sy    | Inte  |                | information assets and          |
| . | stems | grity |                | essential online business       |
|   |       | S     |                | processes with digital          |
|   |       | erver |                | signatures and encryption. This |
|   |       |       |                | product uses a unique           |
|   |       |       |                | server-based software           |
|   |       |       |                | architecture that eliminates    |
|   |       |       |                | the need for client key and     |
|   |       |       |                | configuration management and    |
|   |       |       |                | enables corporate visibility    |
|   |       |       |                | and control over critical       |
|   |       |       |                | business processes. It is       |
|   |       |       |                | designed to conform to          |
|   |       |       |                | regulations and best practices  |
|   |       |       |                | associated with information     |
|   |       |       |                | integrity, such as the 21CFR11  |
|   |       |       |                | FDA regulations                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | Z     | TPW   | [www.zymark.   | Engineered specifically for     |
| 6 | ymark | II    | com](http://ww | time-squeezed labs in a         |
| 1 |       |       | w.zymark.com/) | regulated environment, the TPW  |
| . |       |       |                | completely automates content    |
|   |       |       |                | uniformity and composite assay  |
|   |       |       |                | testing, from preparation       |
|   |       |       |                | through sample introduction and |
|   |       |       |                | provides an audit trail         |
|   |       |       |                | consistent with 21 CFR Part 11. |
+---+-------+-------+----------------+---------------------------------+