Network Quality Package

Increase System Uptime and Comply with Recent Regulations

With two audios seminars, 24 SOPs and free on-line updates

 

 

Version 4.00 just introduced

 

Now with two Options for Ordering

• CD/Binder
• Web Download

Intro

 

Version 4.0 released

New or updated features/documents include

• Updated Primer: Qualification of Networks and Validation of Networked Systems
• New Primer: Using Intranet and Internet in FDA Regulated Environment
• New SOP: Training for GMP Compliance (S-124)
• New SOP: Recording of GMP Raw Data (S-161)
• New SOP: Archiving of GMP Data and Other Documents (S-162)
• New SOP: Validation of Web-Based Applications (S-286)
• New SOP: Using the Internet in Regulated Environments (S-287)
• Internet Quality and Compliance - Step-by-Step Implementation
• New SOP: Qualification of Servers (S-291)
• New SOP: Responsibilities for Computer System Validation (S-277)
• New SOP: Disaster Recovery of Computer Systems (S-319)
• New Audio Seminar: Using Internet and Intranet in Regulated Environments
• New Risk Management Master Plan
• New Network Qualification Project Plan: Template and examples (E-238)
• New Gap Analysis/Checklist: Using Internet and Intranet in FDA Regulated Environments (E-162)

Package Overview

1. Complete New audio seminar: Network Infrastructure Qualification - Introduction and Strategy for Compliance and System Uptime
2. New Audio Seminar: Using the Internet and Intranet in Regulated Environmets
3. Primer: Qualification of networks and validation of networked systems (for details click here)
4. Validation master plan for equipment, computer systems and networks
5. Four Gap analysis/Checklist: Network Quality - 10 pages, Part 11, Using computers in FDA regulated environments and Internet/Intranet complaince
6. 24 SOPs for planned and unplanned changes, for risk assessment of networks, for access testing, 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
7. MD5 software to verify file transfer accuracy with validation documentation.
8. Template for network/system characterization (baselining)
9. Network qualification project plan with schedule, action items, owners and deliverable
10. User Requirement Specifications: Template and examples
11. FDA Warning letters and 483 inspection reports related to networks and/or security aspects (extracts see below)
12. FDA guide and Cyber security and electronic communication
13. Risk management master plan for equipment, computer systems and networks
14. Equipment validation master plan
15. Seven NIST guides on IT security, IT contingency planning, handling security patches and IT risk management
17. 30+ most frequently asked question and answers related to laboratory compliance
18. Two years free on-line updates

Target Audience

• IT/IS managers and personnel
• Operations managers and personnel
• Lab managers and personnel
• QA managers and personnel
• Analytical scientists
• Validation specialists
• Consultants
• Teachers

Format/Price/Ordering

• Format and Pricing
  - 1) Binder with CD, for $499.-
  - 2) Web download for $459.-
  Prices include shipping and two years on-line updates
  VAT will be added for EU countries.
• Availability: Worldwide, shipment within one working day
• Ordering: (SSL secured, recommended for payment by credit card)
  - Electronically from this this web site (SSL secured)
  - Regular mail or fax using the form in PDF or MS Word format

Free Online Update

On-line updates - keeps you on top of ever changing regulatory requirements

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.

The Internet with it's instant publication power can give this update on a much more frequent basis, but is not so popular to learn the fundamentals. The real solution is a combination of both: get the start up package for the fundamentals and the Internet for the updates. That's why the author offers two year free on-line updates with the purchase of the quality package.

Updates include:

• New regulations related to network qualification and computer validation
• New guidelines from agencies and industry task forces
• Interpretations what the new regulations/guidance mean for networks and how to respond
• New SOPs, checklists and examples, related to network qualification, if necessary

Registration is automatically with each package purchase from Labcompliance
To go to the up date page, click here

Support for Compliance

With support for new laws and regulations

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

Topics related to compliance:

• Part 11 checklist, also useful for other 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
• Software and complete validation package to verify file integrity
• Procedure to verify integrity of e-mail attachments
• Test procedure and protocol to test limited access to systems and data

All in One

All in one - makes your work efficient and keeps your budget under control

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?
• What about other legislation such as Sarbanes-Oxley and HIPAA?
• How to validate network operating systems?
• How to qualify data centers, servers and client PCs?
• We validate the application running on the network, so we know that it works, why should we qualify the infrastructure?
• How much testing is enough: should we test each network component, like switches, routers and servers?
• How to verify integrity of file transmission?
• I have multiple clients with the same configuration, should I qualify/validate all of them?
• We have an existing network, where and how should we start?
• How to deal with security patches?
• Our network changes so often, how can I keep it in a validated state?

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 (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 (NEW)

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 173) 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 (NEW)

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. Validation Master Plan (M-171)

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) NEW

7. Network Qualification Project Plan: Template and examples (E-238)

Validation of computer systems requires thorough planning and execution. While the master plan provides a framework for all validation projects, a project plan is required for each individual project. This example list 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) NEW

Risk management is important for laboratories to optimize resources. Inspectors also expect validation activities to be based on 'justified and documented' risk assessment. This risk management master plan helps assess risks of laboratory systems and define validation steps for risk categories.

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

1. Training for GMP Compliance (S-124)  NEW
2. Training for GxP, 21 CFR Part 11 and Computer Validation (S-125)
3. Risk Assessment for Systems Used in GxP Environments (S-134)
4. 21 CFR Part 11 - Scope and Controls (S-137)
5. Recording of GMP Raw Data (S-161)  NEW
6. Archiving of GMP Data and Other Documents (S-162)  NEW
7. Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems (S-237)
8. Maintenance of Equipment (S-241)
9. Testing File Integrity of E-Mail Attachments (S-248)
10. Validation of Commercial Off-the-shelf (COTS) Computer Systems (s-271)
11. Auditing Computer Systems (S-272)
12. Auditing Software Suppliers: Preparation, Conduct, Follow-up (S-273)
13. Responsibilities for Computer System Validation (S-277)  NEW
14. Change Control for Networks and Systems - Planned Changes (S-283)
15. Change Control for Networks and Systems - Unplanned Changes (S-284)
16. Risk Based Qualification of Network Infrastructure (S-285)
17. Validation of Web-Based Applications (S-286)  NEW
18. Using the Internet in Regulated Environments (S-287)
19. Handling Security Patches (S-288)
20. Qualification of PC Clients (S-289)
21. Qualification of Data Centers (S-290) 
22. Qualification of Servers (S-291)  NEW
23. Disaster Recovery of Computer Systems (S-319)  NEW
24. 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

1. Gap Analysis/Checklist: User Requirement Specifications for Software and Computer Systems (E-153)
2. Gap Analysis/Checklist: Qualification of Networks and Validation of Networked Systems (E-157)
3. Gap Analysis/Checklist: Using Computers in FDA Regulated Environments (E-161)
4. Gap Analysis/Checklist: Using Internet and Intranet in FDA Regulated Environments (E-162)
5. Gap Analysis/Checklist: 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

1. Template/Examples: Project Schedule for Network Infrastructure Qualification And System Validation (E-226)
2. Network Qualification Project Plan (E-238)
3. User Requirements for (Networked) Chromatographic Data Systems (E-255)
4. MD5 Checksum File Integrity Check Software with Validation Documentation (E-306)
5. Template/Examples: Network Infrastructure and System Identification (E-326)
6. Test Protocol – Authorized System Access (E-362)
7. 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.

1. Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories. Part 2: Security aspects for systems and application (A-192)
2. Qualification of Network Components and Validation of Networked Systems (A-303)

13. Thirty Most Frequently Asked Questions and Answers

This section includes more than 30 questions and answers on Network Qualification we received during our audio seminars, conference workshops and through e-mail. This section will continually be updated through our package reference website.

14. One Year Online Updates

Package buyers get a full year online support. This will allow buyers to ask and receive all types or questions related to Network and Intranet Quality after package purchase. 

15. FDA and International Regulations and Guidelines

The package includes includes most important guidelines for using computers published by the FDA, the EU and Japan.

16. 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
Contents, Chapter by chapter

1. Introduction

2. Definitions

• Network infrastructure
• Networked systems

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
• Enterprise resource planning systems
• Electronic Document Management Systems
• Manufacturing Execution System (MES) with electronic batch record functionality

6. The Qualification/Validation Approach Using the 4Q Model

• Overview
• Individual steps

7. Validation Master Plan and Validation Team Extended to Networks

• Validation master plan
• Validation team

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

The author, Dr. Ludwig Huber, is an international expert on validation and compliance in regulated industries and laboratories. He has been responsible for the compliance program at Hewlett Packard and Agilent Technologies for more than fifteen years. He serves as a consultant for the industry and regulatory agencies on local and international compliance 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 on the advisory board for the European Compliance Academy and is a member of IVT task force on network qualification. 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, click here