+---+-------+-------+----------------+---------------------------------+
| * | *     | **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 | A     | CA    | [www.assurx.   | Are you concerned about Title   |
| . | 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.     |
+---+-------+-------+----------------+---------------------------------+
| 4 | Auto  | Ra    | [www           | Automsoft\'s RAPID-Pharma is    |
| . | 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.                  |
+---+-------+-------+----------------+---------------------------------+
| 5 | A     | LAB   | [w             | LABTrack incorporates a         |
| . | 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.                  |
+---+-------+-------+----------------+---------------------------------+
| 6 | Be    | Pin   | [              | Pinnacle is the first CDS to be |
| . | 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.           |
+---+-------+-------+----------------+---------------------------------+
| 7 | Blue  | C     | [w             | Our flagship product,           |
| . | 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.                |
+---+-------+-------+----------------+---------------------------------+
| 8 | Br    | St    | <http://www    | Brendan develops laboratory     |
| . | 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.                   |
+---+-------+-------+----------------+---------------------------------+
| 9 | Chem  | eGMP  | [www.egm       | eGMP is compliant with FDA      |
| . | Scope |       | p.com](http:// | regulations, including 21 CFR   |
|   |       |       | www.egmp.com/) | Part 11. And all through a      |
|   |       |       |                | single web browser!             |
+---+-------+-------+----------------+---------------------------------+
| 1 | Cli   | Clin  | [w             | Clinsoft Corporation is the     |
| 0 | 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 |                |                                 |
|   |       | ™     |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 1 | Com   | Sign  | [ht            | Provide electronic signature    |
| 1 | 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.       |
+---+-------+-------+----------------+---------------------------------+
| 1 | Com   | EFL   | [http://www    | A revolutionary, powerful       |
| 2 | 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.  |
+---+-------+-------+----------------+---------------------------------+
| 1 | Creon | Q-    | [www.creon     | The extended use of computer    |
| 3 |       | 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          |
+---+-------+-------+----------------+---------------------------------+
| 1 | Cyber | Cyber | [www           | Cyber-SIGN and Biometric        |
| 4 | -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.        |
+---+-------+-------+----------------+---------------------------------+
| 1 | D     | Chrom | [www.dionex.   | New Electronic Signature and    |
| 5 | 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.     |
+---+-------+-------+----------------+---------------------------------+
| 1 | Doc   | MAS   | <ht            | MASTERControl regulates secure  |
| 6 | 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.             |
+---+-------+-------+----------------+---------------------------------+
| 1 | Doxis | SCCM  | [www.doxis     | Doxis and 21 CFR Part 11        |
| 7 |       |       | .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               |
+---+-------+-------+----------------+---------------------------------+
| 1 | Enmed | Accel | <http://w      | Enmed\'s Acceliant™ Clinical    |
| 8 |       | 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.                        |
+---+-------+-------+----------------+---------------------------------+
| 1 | En    | En    | [http:/        | Digital Certificate technology  |
| 9 | 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.          |
+---+-------+-------+----------------+---------------------------------+
| 2 | eOri  | *     | [www           | The ***e***Original™ system     |
| 0 | ginal | **e** | .eoriginal.com | meets or exceeds all of the FDA |
| . | Inc.  | *Orig | ](http://www.e | requirements for electronic     |
|   |       | inal™ | original.com/) | filings                         |
+---+-------+-------+----------------+---------------------------------+
| 2 | Fishe | D     | <http://       | Significant batch enhancements  |
| 1 | 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.                             |
+---+-------+-------+----------------+---------------------------------+
| 2 | Foss  | V     | [w             | Foss NIRSystems, Inc., a unit   |
| 2 | 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.       |
+---+-------+-------+----------------+---------------------------------+
| 2 | He    | C     | [www.agilent.c | Agilent Cerity Networked Data   |
| 3 | 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.)                   |
+---+-------+-------+----------------+---------------------------------+
| 2 | Hone  | POMS  | <http://       | Honeywell-POMS Corporation is   |
| 4 | 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:                            |
+---+-------+-------+----------------+---------------------------------+
| 2 | Inna  | Wa    | [http://www    | Watson™ uses a central Oracle™  |
| 5 | 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.                   |
+---+-------+-------+----------------+---------------------------------+
| 2 | In    | iFix  | <              | Intellution, Inc., the world\'s |
| 6 | 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.                     |
+---+-------+-------+----------------+---------------------------------+
| 2 | J.D.  | J.D.  | [www           | Designed to meet the needs of   |
| 7 | 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.                        |
+---+-------+-------+----------------+---------------------------------+
| 2 | Kaye  | Vali  | <http://www    | The **Validator 2000** meets    |
| 8 | 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                         |
+---+-------+-------+----------------+---------------------------------+
| 2 | Lab   | Debra | [http://w      | Debra, by Lablogic Systems,     |
| 9 | 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.                             |
+---+-------+-------+----------------+---------------------------------+
| 3 | L     | Lims  | [www.l         | For over 14 years Labtronics    |
| 0 | 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.                     |
+---+-------+-------+----------------+---------------------------------+
| 3 | M     | eM    | [www           | The eMatrix 9 platform combines |
| 1 | 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.                |
+---+-------+-------+----------------+---------------------------------+
| 3 | Micr  | Cybe  | [www.mic       | CyberLAB™, is carefully         |
| 2 | 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.            |
+---+-------+-------+----------------+---------------------------------+
| 3 | Ni    | RE    | <http          | RESULT™ Software Provides tools |
| 3 | colet | SULT™ | ://www.nicolet | to comply with 21 CFR Part 11   |
| . | 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.                    |
+---+-------+-------+----------------+---------------------------------+
| 3 | NuGe  | ARC   | <http://www.n  | NuGenesis can be a key part of  |
| 4 | nesis | HIVE® | ugenesis.com/> | your 21 CFR Part 11 compliance  |
| . | 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.                    |
+---+-------+-------+----------------+---------------------------------+
| 3 | P     | Co    | <http://i      | Use CONNECT to transfer data    |
| 5 | erkin | nnect | nstruments.per | between SQL\*LIMS and           |
| . | 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."                      |
+---+-------+-------+----------------+---------------------------------+
| 3 | Phar  | WinN  | [h             | Pharsight is also working with  |
| 6 | sight | onlin | ttp://www.phar | our customers to help them      |
| . |       |       | 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. |
+---+-------+-------+----------------+---------------------------------+
| 3 | Phase | I     | [www.phase     | Phase Forward\'s InForm         |
| 7 | Fo    | nForm | forward.com](h | solution is designed to allow   |
| . | 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.                      |
+---+-------+-------+----------------+---------------------------------+
| 3 | Pi    | Q     | [www.p         | The 21 CFR Part 11 Electronic   |
| 8 | lgrim | &MIS® | ilgrimusa.com] | Signature requirement defines   |
| . |       |       | (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.      |
+---+-------+-------+----------------+---------------------------------+
| 3 | Pr    | GMP   | [w             | GMPharma is the first e         |
| 9 | icewa | harma | ww.GMPharma.co | business solution jointly       |
| . | terho |       | m](http://www. | developed by                    |
|   | useCo |       | GMPharma.com/) | PricewaterhouseCoopers and      |
|   | opers |       |                | Documentum for enterprise wide  |
|   |       |       |                | management of pharmaceutical    |
|   | Docum |       |                | GMP regulated content.          |
|   | entum |       |                |                                 |
+---+-------+-------+----------------+---------------------------------+
| 4 | Pr    |       | [ht            | Process Analysis & Automation   |
| 0 | ocess |       | tp://www.paa.c | Ltd provides state-of-the-art   |
| . | 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.                   |
+---+-------+-------+----------------+---------------------------------+
| 4 | P     | PRO   | [www.proirb.   | PRO_IRB™ is a Microsoft         |
| 1 | roIRB | _IRB™ | com](http://ww | Access-based Institutional      |
| . | 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.                     |
+---+-------+-------+----------------+---------------------------------+
| 4 | Pr    | PMX   | [ht            | Propack Data was first          |
| 2 | opack |       | tp://www.propa | established as a company in     |
| . | 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.      |
+---+-------+-------+----------------+---------------------------------+
| 4 | QAD   | MF    | [www.q         | QAD understands patient device  |
| 3 |       | G/Pro | ad.com](http:/ | tracking (PDT), serial          |
| . |       |       | /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.                        |
+---+-------+-------+----------------+---------------------------------+
| 4 | Qumas | DocC  | <http://w      | QUMAS DocCompliance® for        |
| 4 |       | ompli | ww.qumas.com/> | Oracle® is a complete           |
| . |       | 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.                        |
+---+-------+-------+----------------+---------------------------------+
| 4 | Roc   | RSVi  | <http:/        | Rockwell Automation has         |
| 5 | kwell | ew32™ | /support.softw | announced that its flagship HMI |
| . | 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.           |
+---+-------+-------+----------------+---------------------------------+
| 4 | SAP   | cGMP  | [www.s         | Create of EBR after final       |
| 6 |       | Regu  | ap.com](http:/ | completion of Production order, |
| . |       | 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.            |
+---+-------+-------+----------------+---------------------------------+
| 4 | Scien | EZ    | <http://w      | Manufacturer of EZ Chrom Elite  |
| 7 | tific | Chrom | ww.scisw.com/> | v2.7 chromatography data        |
| . | 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.      |
+---+-------+-------+----------------+---------------------------------+
| 4 | Shi   | Class | [w             | Supplier of Chromatography and  |
| 8 | madzu | VP    | ww.shimadzu.co | analytical equipment, 21 CFR    |
| . |       |       | 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                       |
+---+-------+-------+----------------+---------------------------------+
| 4 | Si    | Appr  | [http:/        | Meets FDA 21 CFR Part 11 right  |
| 9 | lanis | oveIT | /www.silanis.c | out of the box ApproveIt from   |
| . | 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             |
+---+-------+-------+----------------+---------------------------------+
| 5 | Sotax | Win   | <http://w      | SOTAX is the technology leader  |
| 0 | AG    | SOTAX | ww.sotax.com/> | in the development and          |
| . |       |       |                | 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.                         |
+---+-------+-------+----------------+---------------------------------+
| 5 | S     | Trac  | [www.sparta-sy | Sparta Systems\' TrackWise is a |
| 1 | parta | kWise | stems.com](htt | powerful system for tracking    |
| . | 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.                        |
+---+-------+-------+----------------+---------------------------------+
| 5 | Ta    | TeC   | [www.taratec.c | TeC, Taratec's e-Compliance     |
| 2 | ratec |       | om](http://www | Solution, will help ensure      |
| . |       |       | .taratec.com/) | compliance for computer systems |
|   |       |       |                | used in all phases of the       |
|   |       |       |                | product development cycle.      |
+---+-------+-------+----------------+---------------------------------+
| 5 | T     | Nau   | <http://www.la | Thermo LabSystems has been      |
| 3 | hermo | tilus | bsystems.com/> | successfully developing and     |
| . | 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.              |
+---+-------+-------+----------------+---------------------------------+
| 5 | W     | Mille | [www.waters.   | Millennium 32 Chromatography    |
| 4 | aters | nnium | com](http://ww | data system. The first major    |
| . | 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.     |
+---+-------+-------+----------------+---------------------------------+
| 5 | Werum | PAS-X | <http://w      | Werum supplies perfect          |
| 5 |       | MES   | ww.werum.com/> | technical MES (Manufacturing    |
| . |       |       |                | 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.                  |
+---+-------+-------+----------------+---------------------------------+
| 5 | W     | Data  | <ht            | Wimmer Systems has developed    |
| 6 | immer | Compl | tp://www.wimme | the Data Compliance System™ for |
| . | 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.   |
+---+-------+-------+----------------+---------------------------------+
| 5 | Xcert | S     | <http://w      | Sentry CA provides a            |
| 7 |       | entry | ww.xcert.com/> | certificate issuance and        |
| . |       | 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.                         |
+---+-------+-------+----------------+---------------------------------+
| 5 | Z     | TPW   | [www.zymark.   | Engineered specifically for     |
| 8 | ymark | II    | com](http://ww | time-squeezed labs in a         |
| . |       |       | 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. |
+---+-------+-------+----------------+---------------------------------+