Source: http://www.labcompliance.com/books/network/default.aspx
Timestamp: 2017-07-28 02:38:29
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Network Qualification for FDA Compliance and System Uptime
All documents as shown here and more are included in the package Network Quality Package
- now with audio seminar and SOP for Virtual Network Qualification - Increase System Uptime and Comply with Recent Regulations
With three audios seminars, 28 SOPs and free on-line updates
Version 5.0 With two Options for Ordering
Web Download Intro
Version 5.0 New or updated features/documents include
Updated Primer: Qualification of Networks and Validation of Networked Systems
New Audio Seminar: Qualification and Use of Virtual Networks in Regulated Environments
New SOP: Qualification of Virtual Networks
New SOP; Archiving and Retrieval of GMP Data and Other Documents New SOP: Selecting the Right Software and Equipment Supplier for Compliance
New checklist: What Regulated Users should expect from Suppliers of Equipment and Computer Systems
New Example: Supplier Quality Agreement
Updated Equipment Validation Master Plan
Updated Network Qualification Plan
Six updated SOPs
Three Audio Seminars: FDA Compliant IT Infrastructure and Network Qualification (new), Using the Internet and Intranet in Regulated Environments, Qualification and Use of Virtual Networks in Regulated Environments (new)
Primer: Qualification of networks and validation of networked systems (for details click here)
Validation master plan for equipment, computer systems and networks Six Gap analysis/Checklist: Network Quality - 10 pages, Part 11, Using computers in FDA regulated environments and Internet/Intranet compliance, what regulated users should expect from Suppliers of equipment and computer Systems
28 SOPs for planned and unplanned changes, for risk assessment of networks, for access testing, for virtual network qualification, data center qualification, PC client qualification, server qualification, using the Internet in regulated environment, handling security patched, validation of COTS computer systems, part 11 controls, for people qualification, f or auditing computer systems and for development of test scripts
MD5 software to verify file transfer accuracy with validation documentation.
Template for network/system characterization (baselining)
Network qualification project plan with schedule, action items, owners and deliverable
User Requirement Specifications: Template and examples FDA Warning letters and 483 inspection reports related to networks and/or security aspects.
FDA guide and Cyber security and electronic communication
Risk management master plan for equipment, computer systems and networks
Equipment validation master plan Seven NIST guides on IT security, IT contingency planning, handling security patches and IT risk management
30+ most frequently asked question and answers related to qualification of conventional and virtual networks
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Qualification of network infrastructure and validation of networked systems is almost as dynamic as computer technology. Regulatory agencies and industry task forces frequently release or update regulations or guidance documents. A book can give the background, the fundamentals and an overview on regulations and inspection practices at a particular point in time - but updates reflecting on-going changes are practically limited to a 3 to 5 year time frame.
Updates include: New regulations related to network qualification and computer validation
Interpretations what the new regulations/guidance mean for networks and how to respond
New SOPs, checklists and examples, related to network qualification, if necessary
To go to the up date page,
Federal laws and regulations mandate to put controls and measures on a company network to ensure security, confidentiality, integrity and long term availability of data.. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this new legislation network qualification and compliance becomes a much more recognizable issue at higher levels of management. However currently there is no official guideline and the situation is similar to what happened with computer validation in early 90's and with general part 11 issues from 2000 to 2003. Until there will be an industry wide accepted approach companies either waste valuable resources because doing too much or take a risk to fail inspections because not doing enough or doing it wrong. This Network Quality Package will help to comply with these regulations
Procedure Risk Assessment for Systems Used in GxP Environments, also useful for other regulations
Procedures: 21 CFR Part 11 - Scope and Controls, also useful for other regulations
Inspection reports and FDA warning letters,. They are useful to learn what auditors are looking at and how to avoid mistakes others made Procedures to handle security, e.g., security patches, training
Qualification of network infrastructure and validation of networked systems can be a complex task. This gets even more complex and even confusing when information is obtained from different sources. Frequently they give a high level overview talking about generic IQ/Q/PQ but none gives a full picture and details that are required for quick implementation in laboratories. This package is a single source covering all aspects. It is written by a single author who has more than 20 years practical international experience and understands qualification and validation from ground. The author has been ranked as number one presenter at various international conferences and the package answers all questions typically raised at these conferences:
What does network qualification mean?
Is there an official standard from an agency or industry?
What do inspectors ask and what do they want to see? Should networks comply with 21 CFR Part 11?
Can we use Virtual Networks in regulated environments, and if so, how to qualify them?
How to validate network operating systems?
How to qualify data centers, servers and client PCs?
Why to go through the hassle and read several books with lots of redundant information. With this validation book, targeted to laboratories, you get all answers in one. This not only saves time, it's also cost effective. And as requirements change, you get the answers through the on-line update service. Detailed Contents 1. Primer: Qualification of Networks and Validation of Networked Systems (M-212) (UPDATE)
This gives an overview on regulatory requirements and approaches and principles for network infrastructure qualification and system validation. It discusses and gives recommendations for developing a qualification pla n plan, setting specifications, installation, testing for initial and on-going operation of the system. All from business AND regulatory perspective. Updates will be available through the on-line update service.
2. Primer: Using Intranet and Internet in FDA Regulated Environment (M-211)
This gives an overview on regulatory requirements and Internet technology. It discusses and gives recommendations for digital signatures, validation of internet transactions and internet security. All from business AND regulatory perspective. Updates will be available through the on-line update service.
3. Audio Seminar: IT Infrastructure and Network Qualification (Audio 305) NEW
Introduction and Strategies for Compliance and System Uptime. In a one our seminar Dr. Ludwig Huber gives an overview on the regulation and he guides the audience through a logical step-by-step process on how to qualify IT Infrastructure in the most cost-effective way.
4. Audio Seminar: Using Internet and Intranet in Regulated Environments (Audio 180)
Requirements and Tools for E-Mails, Web-Applications and Corporate Networks. In a one our seminar Dr. Ludwig Huber gives an overview on the regulation and he guides the audience through a logical step-by-step process on how to make intranet and internet applications compliant in a most cost-effective way.
5. Audio Seminar: Qualification and Use of Virtual Networks in Regulated Environments (Audio 294) NEW
Virtual networks can significantly reduce investment and operating costs for IT operations. However when used in FDA and other regulated environments they need to be qualified to ensure consistent on-going performance and security and integrity of stored and managed data. Dr. Ludwig Huber will present an overview for qualification of virtual networks and give detailed recommendations for implementation. strategy and 5. Validation Master Plan (M-171) (UPDATE) Validation is the key requirement for . A validation master plan is the first and most important validation document. It improves validation efficiency and ensures consistent implementation within a company. It is also an ideal document to document and demonstrate a company's approach for validation. 6. Internet Quality and Compliance - Master Plan (M-172)
7. Network Qualification Project Plan: Template and examples (E-238) UPDATE
Qualification of networks systems requires thorough planning and execution. While the master plan provides a framework for all qalification steps, a project plan is required for each individual project. This example lists project steps and also has an appendix with a project schedule with columns for project items, deliverables, owners and timing.
8 Risk Management Master Plan (M-131) UPDATE
9. Standard Operating Procedures (SOPs)
In regulated environments routine operations should follow written procedures. They help to implement processes and and technical controls in a consistent manner. The Network Quality Package includes 24 example SOPs
Training for GMP Compliance (S-124) Training for GxP, 21 CFR Part 11 and Computer Validation (S-125)
Recording of GMP Raw Data (S-161) Archiving and Retrieval of GMP Data and Other Documents (S-162) (NEW) Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems (S-237)
Handling Deviations during Equipment and Computer System Testing (S-238)
Selecting the Right Software and Equipment Supplier for Compliance (S-251) (NEW)
Validation of Commercial Off-the-shelf (COTS) Computer Systems (s-271)
Auditing Software Suppliers: Preparation, Conduct, Follow-up (S-273)
Responsibilities for Computer System Validation (S-277) Change Control for Networks and Systems - Planned Changes (S-283) UPDATE
Change Control for Networks and Systems - Unplanned Changes (S-284) UPDATE
Risk Based Qualification of Network Infrastructure (S-285)
Validation of Web-Based Applications (S-286) Using the Internet in Regulated Environments (S-287)
Handling Security Patches (S-288) UPDATE
Qualification of PC Clients (S-289)
Qualification of Data Centers (S-290) Qualification of Servers (S-291) Qualification of Virtual Networks (S-292) NEW
Disaster Recovery of Computer Systems (S-319) Access Rights to Computer Systems and Data (S-320)
10. Check Lists Checklists are key to identify missing procedures and technical controls to for network and Internet/intranet compliance. The Package includes two gap analyses
What Regulated Users should expect from Suppliers of Equipment and Computer Systems (E-148-06) NEW
User Requirement Specifications for Software and Computer Systems (E-153)
Qualification of Networks and Validation of Networked Systems (E-157) UPDATE
Using Internet and Intranet in FDA Regulated Environments (E-162)
21 CFR Part 11 - Electronic Records & Signatures (E-168)
11 Templates and Examples
Templates and examples help implement the computer system validation processes effectively and consistently throughout your organization. The Package includes templates/examples for
Supplier Quality Agreement (149-01) NEW
Template/Examples: Project Schedule for Network Infrastructure Qualification And System Validation (E-226)
Network Qualification Project Plan (E-238)
User Requirements for (Networked) Chromatographic Data Systems (E-255)
MD5 Checksum File Integrity Check Software with Validation Documentation (E-306)
Template/Examples: Network Infrastructure and System Identification (E-326)
Test Protocol â€“ Authorized System Access (E-362)
Getting and Using Digital Signatures for E-mails (E-505)
12. Reference Papers
Reference papers are quite useful to get some more back-ground information and more details on various topics. The package includes 2 papers. Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories. Part 2: Security aspects for systems and application (A-192)
Qualification of Network Components and Validation of Networked Systems (A-303)
13. Thirty Most Frequently Asked Questions and Answers UPDATE
This section includes more than 30 questions and answers on Qualification of Conventional and Virtual Networks we received during our audio seminars, conference workshops and through e-mail. This section will continually be updated through our package reference website. 14. Full text FDA Warning Letters
FDA Warning letters and 483 inspection reports related to networks and/or security aspects. 15. On-line Update
Subscribers of the package get two years on-line updates through a password protected website. This includes quality systems and regulatory updates and other new documents such as SOPs, examples and templates.
Primer: Qualification of Networks and Validation of Networked Systems
2. Definitions Network infrastructure
3. FDA Findings and Expectations Examples from 483 Inspectional Observations
Examples from FDA Warning Letters 4. Systems and Tasks to be Validated Systems used in FDA regulated environments (GxP)
Business critical systems 5. Examples of Networked Systems Laboratory systems
Manufacturing Execution System (MES) with electronic batch record functionality
6. The Qualification/Validation Approach Using the 4Q Model Overview
7. Validation Master Plan and Validation Team Extended to Networks Validation master plan
8. Setting Specifications 9. Installation 10. Testing 11. Setting up and Maintaining Data Security 12. Data Back-up, recovery and Contingency Planning 13. Change Control 14. Documentation 15. Implementation Summary Appendix A. Glossary Appendix B. References
The author, Dr. Ludwig Huber, is an international expert on laboratory compliance and quality standards. He has been responsible for the compliance and quality standards program at Hewlett Packard and Agilent Technologies for more than 20 years. He serves as a consultant for the industry and agencies on local and international compliance and quality issues. He has been a member of the US PDA task force on 21 CFR Part11 and of the GAMP Special Interest Group for Laboratory Computer Systems. He is also was/is on the advisory board for the European Compliance Academy and IVT's GxP Journals. Several of his previous books have been bestsellers and several times he has been ranked as number one presenter at various international conferences. For publications, presentations and other achievements,