Computer System Validation Package

Do it right the first time

With 35 SOPs, 21 examples/templates/forms, two audio seminars and free on-line updates

Version 3 just introduced

 

Testimonials

So far we have received very positive feedback from users of the package. To learn how the package helped to validate software and computer systems, click here.

Now with two Options for Ordering

• CD/Binder
• Web Download

Intro

Training tools, strategies for compliance and tools for implementation

Software and computer system validation is required by regulations and it is important to ensure system uptime during ongoing use. Despite of more than 30 years experience and availability of FDA and industry guidance, computer validation still confuses people.

This package helps you to

• Get a good understanding on FDA and industry requirements
• Develop a strategy and master plans
• Implement the strategies with 50+ reference materials such as SOPs, checklists, forms, templates

Version 3.0 just released

New or updated features/documents in version 3 include

• Two new one hour audio presentations with Q&As:
  - Computer System Validation: Introduction, Requirements and Strategies for Implementation (Audio 156)
  - Cost Effective Software and Computer System Validation: Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5 (Audio 202)
• SOP: Data Back-up and Restore (S-317)
• SOP: Developing a Gap Analysis for Software and Computer System Validation (S-249)
• SOP: Access Control to Computer Systems and Data (S-320)
• SOP: Archiving and Retrieval of GMP Data and Other Documents (S-162)
• SOP: Disaster Recovery for Computer Systems (S-319)
• 9 Examples for the Validation of Electronic Document Management Systems
  (Validation plan, Requirement Specifications, Vendor assessment, IQ, OQ, PQ, Test plan, Test protocol, Validation report) (E-741)
• Updated: Computer System Validation Master Plan
• Updated: Validation Plan - Chromatography Data Systems
• Updated: Step-by-Step Implementation
• Three new forms

Testimonials, References and Sample Pages

So far we have received very positive feedback from users of the package. To learn how the package helped to validate computer systems, click here.

To see the table of contents and example pages of the Computer System Validation Master Plan, sample pages from an SOP and several pages of a checklist, download a zip file (sample pages are in PDF format, the products comes with word and/or PDF formats)

Package Overview

1. Two new one hour audio seminars with Q&As and scripts:
   - Computer System Validation: Introduction, Requirements and Strategies for Implementation (Audio 156)
   - Cost Effective Software and Computer System Validation:Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5 (Audio 202)
   (Train yourself and others on regulations and industry practices)
2. Primer: Validation of Computer Systems
3. Computer System Validation Master Plan and Project Plan
4. Software and Computer Validation: Step by Step Implementation
5. Four Gap Analyses/Checklists: Using computers in FDA regulated environments, user requirements for computer systems, assessment of software vendors, New EU annex 11 - Using Computers
6. 31 SOPs for change control, for risk assessment of computer systems, for development and maintenance of test scripts, validation of COTS computer systems, part 11 controls, for computer system training, for auditing computer systems, for data back-up and restore, for access rights for computer systems, for retention and archiving of electronic records, for validation of electronic document management systems and for disaster recovery of computer systems, for developing a gap analysis
7. MD5 software to verify file transfer accuracy. This comes with validation documents.
8. Template for computer system and network characterization (baselining)
9. 20 Practical Examples for Validating a Document Management System and Chromatographic Data System
10. Reference Paper: Risk based validation of commercial off-the-shelf computer systems.
11. 30+ most frequently asked question and answers related to computer system validation.
12. User Requirement Specifications: template and examples
13. Functional testing: template and examples
14. 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 $649.-
  - 2) Web download for $599.-
  Prices include shipping and two years on-line updates
  VAT will be added for EU countries.
• Size: More than 1000 pages, when printed
• Availability: Worldwide, shipment within one working day after order entry and payment has been received
• 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 Updates

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

Laboratory compliance is quite dynamic. What was enough yesterday is not enough any more today and what was necessary last year may not be any more next year.

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 procedures and the Internet for the updates. That's why the author offers two year free on-line updates with the purchase of the Laboratory Compliance package.

Updates include:

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

Registration is automatically with each package purchase from Labcompliance

Click here to go to the update site (requires access information)

Support for Compliance

With support for new laws and regulations

Federal laws and regulations mandate to put controls and measures on computer systems to ensure security, confidentiality, integrity and long term availability of data.. Examples are 21 CFR Part 11, Good Laboratory Practices, Good Manufacturing Practices and Good Clinical Practices regulations and Guidelines. This Computer System Validation Package will help to comply with regulations and still meet business requirements.

Topics related to compliance:

• Checklist: using computer systems in FDA regulated environments
• Part 11 checklist, also useful for other regulations
• Checklist: New EU Annex 11 - Using Computers
• Procedure: Risk Assessment for Systems Used in GxP Environments, also useful for other regulations
• Procedure: Risk Based Validation
• Software and complete validation package to verify file integrity
• Test procedure and protocol to test limited access to systems and data
• More than 50 regulations and guidelines related to computer validation

All in One

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

Computer Validation 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 compliance but none gives a full picture and details that are required for quick implementation.

This package is a single source covering all aspects. It is written by a single author who has more than 10 years practical international experience and understands FDA compliance 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

• How to develop a computer validation master plan?
• What is the level of detail of user requirement and functional specifications?
• How to qualify the supplier: when is a vendor audit a must?
• What and how much to test at installation?
• I have multiple installations with the same configurations, should I test all of them or is one enough?
• How to document functional testing - when do I need to make screen captures?
• How to initiate and document changes to my computer system?
• How to validate spreadsheets such as Excel?
• How to qualify PC clients?
• What should we do when we retire a computer system?
• How to validate existing (legacy) systems?
• How to validate our document management system?
• How to validate our laboratory computer system?

Why to go through the hassle and read several books with lots of redundant information. With this validation package, 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: Validation of Software and Computer Systems

This gives an overview on regulatory requirements and validation principles. It discusses and gives recommendations for developing a validation plan, setting specifications, vendor qualification, 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. Two Audio seminars: (NEW)

 - Computer System Validation: Introduction, Requirements and Strategies for Implementation (Audio 156)
- Cost Effective Software and Computer System Validation: Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5 (Audio 202)

In the first seminar Dr. Ludwig Huber gives an introduction on regulatory requirements  and strategies for software and computer validation

The second seminars helps IT and validation processionals to make validation most cost and time effective.

3. Step-by-Step Implementation (UPDATE)

This documents guides owners of validation projects through the complete process from planning to implementation and on-going validation.

4. Computer System Validation Master Plan (UPDATE)

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. A validation master plan is also officially required for EU GMPs through Annex 15.

5. Computer System Validation Project Plan: Template and examples (UPDATE)

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.

6. Standard Operating Procedures (SOPs)

In FDA regulated environments routine operations should follow written procedures. They help to implement processes and and technical controls in a consistent manner. The Computer System Package includes several example SOPs

1. Writing and Distribution of Electronic SOPs (S-107) (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. Recording of GMP Raw Data (S-161) (NEW)
5. Archiving and Retrieval of GMP Data and other documents (S-162)
6. Archiving and Retrieval of GCP Source Data (S-164) (NEW)  
7. Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems (S-237)
8. Developing a Gap Analysis for Software and Computer System Validation (S-249)
9. Risk Based Validation of Computer Systems (S-252)
10. Development of User Requirement Specifications for Computers (S-253)
11. Configuration Management and Version Control of Software (S-259)
12. Revalidation of Software and Computer Systems (S-260) (NEW)
13. Retirement of Computer Systems (S-261)
14. Change Control of Software and Computer Systems (S-262)
15. Validation of Macro Programs and Other Application Software (S-263)
16. Using Macros and Spreadsheets in a Regulated Environment (S-265)
17. Validation of Electronic Laboratory Notebooks (S-267)
18. Validation of Document Management Systems (S-270)
19. Validation of Commercial Off-the-shelf (COTS) Computer Systems (S-271)
20. Auditing Computer Systems (S-272)
21. Auditing Software Suppliers: Preparation, Conduct, Follow-up (S-273)
22. Quality Assessment of Software and Computer System Suppliers (S-274)
23. Responsibilities for Computer System Validation (S-277) (NEW)
24. Qualification of PC Clients (S-289)
25. Retention and Archiving of Electronic Records (S-315)
26. Scanning of Paper Records for GxP Compliant Archiving (S-316)
27. Data Back-up and Restore (S-317)
28. Handling Contingency Situations for Computer Systems (S-318) NEW
29. Disaster Recovery for Computer Systems (S-319)
30. Access Control to Computer Systems and Data (S-320)
31. Validation of Laboratory Computer Systems (S-656)

7. Checklist / Worksheets

Gap analyses and checklists are key to identify missing procedures and technical controls for computer system validation. The Package includes three gap analyses

1. Checklist: Cost Effective Computer System Validation (E-150) NEW
2. Checklist: EU GMP Annex 11 - Using Computers  (E-151) NEW
3. User Requirement Specifications for Software and Computer Systems (E-153)
4. Commercial Off-the-Shelf Computer Systems (E-160)
5. Assessment of Software Vendors (E-321)

8. 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. Requirement Specifications For Excel Applications (E-269)
2. MD5 Checksum File Integrity Check Software with Validation Documentation: DQ, IQ, OQ, PQ (E-306)
3. User Requirement Specifications - 20 Good/Bad Examples (E-308)
4. Computer System and Network Identification (E-326)
5. Template/Examples: Test Protocol For Excel™ Spreadsheet Application (E-358)
   (with traceability matrix): Includes 12 test scripts examples for functional testing, includes boundary testing, out of range testing, test traceability matrices: tests vs. specifications, specifications vs. test cases, test summary sheet
6. Testing of Authorized System Access (E-362)
7. Case Studies: Configuration Management and Change Control for Software and Computer Systems. (E-413)
8. Validation Plan -  Electronic Document Management System (E-741-01)
9. Requirement Specifications -  Electronic Document Management System (E-741-02)
10. Vendor assessment -  Electronic Document Management System (E-741-04)
11. DQ -  Electronic Document Management System (E-741-05)
12. Test plan -  Electronic Document Management System (E-741-06)
13. IQ -  Electronic Document Management System (E-741-07)
14. OQ -  Electronic Document Management System (E-741-08)
15. PQ - Electronic Document Management System (E-741-09)
16. Validation Report - Electronic Document Management System (E-741-11)
17. Validation Plan for Chromatographic Data Systems (E-781-01)
18. Requirement Specifications For Chromatographic Data Systems (E-781-02)
19. Supplier Assessment - Chromatography Data System (E-781-04) NEW
20. Test plan - Chromatography Data System (E-781-06) NEW

9. Forms

Forms help implement the computer system validation processes effectively and consistently throughout your organization. The Package includes forms for

1. Computer System Validation Project Team (K-1311)
2. Computer System Validation Steering Committee (K-1312)
3. Computer Validation Training (K-1313)
4. Requirement Specifications Table (K-1319)
5. Change Request Form (K-1320)
6. Change Release Form (K-1321)
7. Retirement Request Form (K-1322)
8. Validation Deliverables (K-1323)
9. Computer System Identification for Validation (K-1324) NEW
10. Computer Incident Report (K-1361) NEW
11. Cost Control for Computer Systems (K-1371) NEW
12. Traceability Matrix Excel Specifications-Test Cases (K-1342)

10. 30+ Most Frequently Asked Questions and Answers

This section includes more than 30 questions and answers on software and computer system validation we received during our audio seminars, conference workshops and through e-mail.

11. FDA Regulations and Guidelines

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

12. On-line Updates

Subscribers of the package get two years on-line updates through a password protected website. This includes regulatory updates and other new documents such as SOPs, examples and templates.

Testimonials/References

 

 

The Feedbacks on the Package have been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

 

• Mr. Lawrence DeHeer, President, Blaze Systems Corporation, USA (Ref 1032)
  Comprehensive coverage with examples. Well structured and broken down into manageable pieces. Aligns and supports the most rigorous examples we have encountered and also demonstrates the inadequacies of less rigorous examples we have seen, helping us to guide our customers. This package is a must have starting point for anyone tasked with insuring a credible software validation effort. Worth many times the price. The package did exceed my expectations.
  
• Michael Brooks, AIT Laboratories, Quality Assurance, USA
  The package did exceed my expectations. It has more than enough of what we need to meet regulatory regulations. Very well put together (Ref 1002)
  
• Mr. Suwardi Bambang Irawan Syah,  Idaman Pharma Mfg Sdn Bhd,, Malaysia
  Feedback: The package clearly stated how to do the CSV..
  The package did exceed my expectations. (Ref T-1027)
  
• Mr. Jim Dougherty, Sr. Mgr. Software Iron Mountain, IT Software Engineering,  Engineering, USA
  Comprehensive coverage of topics, Excellent examples. (Ref: T-1028)
  

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