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All documents as shown here are included in the package, and many more!

A total of 22 SOPs are included in the package. 15 of them are shown here.

 

9 Forms are included in the package. They help to make computer system validation consistent and effective

Cost Effective Validation of Computer Systems

 

Computer System Validation Package

Do it right the first time

With 38 SOPs, 11 Checklists, 21 examples/templates, 15 forms, two audio seminars and free on-line updates

 Version 4.00  

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
  • 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 4.xx just released

New or updated features/documents in version 4.xx include

  • One hour audio presentation with PPT file, script and with Q&As: (NEW)
    - Cost Effective Computer System Validation: Step-by-Step  (Audio 279)
  • SOP: Recording of GCP Source Data (S-163) (NEW)
  • SOP: Responsibilities of Sponsors and Clinical Sites for Computerized Systems (S-165) (NEW)
  • SOP: Handling Deviations during Equipment and Computer System Testing (S-238) (NEW)
  • SOP: Selecting the Right Software and Equipment Supplier for Compliance (S-251-02 (NEW)
  • SOP: Periodic Evaluation and Review of Computerized Systems (S-258) (NEW)
  • SOP: Retrospective Validation of Computerized Systems (S-269)(NEW)
  • SOP: Using Cloud Computing in Regulated Environments (S-293) (NEW)
  • Checklist: Periodic Evaluation and Review of Computerized Systems (E-148-01) (NEW)
  • Checklist: Revalidation of Computer Systems (E-148) (NEW)
  • Checklist: EU GMP Annex 11: Version 2011 (E-151) (NEW)
  • Checklist: Using Computerized Systems in Clinical Trials (E-154) (NEW)
  • Checklist: Retrospective Validation of Computer Systems (E-159) (NEW)
  • Checklist: Retirement of Computer Systems (E-173) (NEW)
  • Checklist: Contingency and Disaster Recovery Planning for Computer Systems (E-195) (NEW)
  • List with Required Procedures for Computer Validation (E-310) (NEW)
  • List with Required Records for Computer Validation (E-311) (NEW)
  • Example: Installation Qualification: Chromatography Data System (E-781-07) (NEW)
  • Computer System Validation Master Plan (UPDATE)
  • Validation Plan - Chromatography Data Systems (UPDATE)
  • Step-by-Step Implementation (UPDATE)
  • Three new forms (UPDATE)

Testimonials

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.

Package Overview

  1. One hour audio presentation with PPT file, script and with Q&As: (NEW)
    - Cost Effective Computer System Validation: Step-by-Step  (Audio 279)
  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. 11 Gap Analyses/Checklists for various aspects of using and validating computer systems from purchasing to retirement
  6. 38 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 and for using cloud computing in regulated environments
  7. MD5 software to verify file transfer accuracy. This comes with validation documents.
  8. Template for computer system and network characterization (baselining)
  9. 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
  • Users of computer systems
  • Validation specialists
  • Consultants
  • Teachers

Format/Price/Ordering

  • Format and Pricing
    - 1) Binder with CD, for $6
    99.-
    - 2) Web download for $
    649.-
    Prices include shipping and two years on-line updates
    VAT will be added for EU countries.
  • Size: More than 500 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 SOPs, checklists, examples and forms related to validation and use of computer systems, if necessary
  • New FDA Warning Letters related to validation and use of computer systems
  • New questions and answers

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 FDA 21 CFR Part 11, EU Annex 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 20 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?
  • How to use cloud computing

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. Audio seminars: (NEW)

 Seminar #1: Cost Effective Computer System Validation: Step-by-Step  (Audio 279)

In this new seminar Dr. Ludwig Huber guides IT, Operational and QA managers and staff through the process of software and computer system validation from writing specifications and vendor qualification to installation, operational and performance qualification. Each step is illustrated by templates and example which makes implementation easy and cost effective.

Seminar #2: Periodic Review and Evaluation of Computer Systems  (Audio 271)

Periodic Review and Evaluation is a new requirement for computer systems. Attendees learn everything about the new requirements and get strategies and tools for easy implementation

 

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 38 example SOPs

  1. Writing and Distribution of Electronic SOPs (S-107)  
  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)
  5. Archiving and Retrieval of GMP Data and other documents (S-162)
  6. SOP: Recording of GCP Source Data (S-163) NEW
  7. Archiving and Retrieval of GCP Source Data (S-164)
  8. Responsibilities of Sponsors and Clinical Sites for Computerized Systems (S-165) NEW
  9. Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems (S-237)
  10. Handling Deviations during Equipment and Computer System Testing (S-238) NEW
  11. Developing a Gap Analysis for Software and Computer System Validation (S-249)
  12. Selecting the Right Software and Equipment Supplier for Compliance (S-251-02 NEW
  13. Risk Based Validation of Computer Systems (S-252)
  14. Development of User Requirement Specifications for Computers (S-253)
  15. Periodic Evaluation and Review of Computerized Systems (S-258) NEW
  16. Configuration Management and Version Control of Software (S-259)
  17. Revalidation of Software and Computer Systems (S-260)
  18. Retirement of Computer Systems (S-261)
  19. Change Control of Software and Computer Systems (S-262)
  20. Validation of Macro Programs and Other Application Software (S-263)
  21. Using Macros and Spreadsheets in a Regulated Environment (S-265)
  22. Validation of Electronic Laboratory Notebooks (S-267)
  23. Retrospective Validation of Computerized Systems (S-269) NEW
  24. Validation of Document Management Systems (S-270)
  25. Validation of Commercial Off-the-shelf (COTS) Computer Systems (S-271)
  26. Auditing Computer Systems (S-272)
  27. Auditing Software Suppliers: Preparation, Conduct, Follow-up (S-273)
  28. Quality Assessment of Software and Computer System Suppliers (S-274)
  29. Responsibilities for Computer System Validation (S-277)
  30. Qualification of PC Clients (S-289)
  31. Using Cloud Computing in Regulated Environments (S-293) NEW
  32. Retention and Archiving of Electronic Records (S-315)
  33. Scanning of Paper Records for GxP Compliant Archiving (S-316)
  34. Data Back-up and Restore (S-317)
  35. Handling Contingency Situations for Computer Systems (S-318)  
  36. Disaster Recovery for Computer Systems (S-319)
  37. Access Control to Computer Systems and Data (S-320)
  38. 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 10 checklists

  1. Revalidation of Computer Systems (E-148) NEW
  2. Periodic Evaluation and Review of Computerized Systems (E-148-01) NEW
  3. Cost Effective Computer System Validation (E-150)
  4. EU GMP Annex 11 Version 2011 - Using Computers  (E-151) NEW
  5. User Requirement Specifications for Software and Computer Systems (E-153)
  6. Using Computerized Systems in Clinical Trials (E-154) NEW
  7. Retrospective Validation of Computer Systems (E-159) NEW
  8. Validation of Commercial Off-the-Shelf Computer Systems (E-160)
  9. Retirement of Computer Systems (E-173) NEW
  10. Contingency and Disaster Recovery Planning for Computer Systems (E-195) NEW
  11. Assessment of Software Vendors (E-321)

8. Templates, Examples and Study Cases

Templates, examples and case studies 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. List with Required Procedures for Computer Validation (E-310) NEW
  5. List with Required Records for Computer Validation (E-311) NEW
  6. Computer System and Network Identification (E-326)
  7. Template/Examples: Test Protocol For Excelâ„¢ 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
  8. Testing of Authorized System Access (E-362)
  9. Case Studies: Configuration Management and Change Control for Software and Computer Systems. (E-413)
  10. Validation Plan -  Electronic Document Management System (E-741-01)
  11. Requirement Specifications -  Electronic Document Management System (E-741-02)
  12. Vendor assessment -  Electronic Document Management System (E-741-04)
  13. DQ -  Electronic Document Management System (E-741-05)
  14. Test plan -  Electronic Document Management System (E-741-06)
  15. IQ -  Electronic Document Management System (E-741-07)
  16. OQ -  Electronic Document Management System (E-741-08)
  17. PQ - Electronic Document Management System (E-741-09)
  18. Validation Report - Electronic Document Management System (E-741-11)
  19. Validation Plan for Chromatographic Data Systems (E-781-01)
  20. Requirement Specifications For Chromatographic Data Systems (E-781-02)
  21. Supplier Assessment - Chromatography Data System (E-781-04)
  22. Test plan - Chromatography Data System (E-781-06)
  23. IQ: Chromatography Data System (E-781-07) 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)
  10. Documenting Corrective Actions of Computer System Reviews(K-1360) NEW
  11. Computer Incident Report (K-1361)
  12. Documenting Computer System Validation Audits (K-1366) NEW
  13. Cost Control for Computer Systems (K-1371)
  14. Identification of Projects with Highest Potential for Cost Savings (K-1372) NEW
  15. Traceability Matrix Excel Specifications-Test Cases (K-3142)

10. 30+ Most Frequently Asked Questions and Answers UPDATE

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. 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

 

 

All the testimonials have been received through the feedback forms to Labcompliance seminars, Compliance packages. and SOPs The authors agreed to publish them. All information on the submitters of the testimonials can be reviewed in the Labcompliance archive.

 

  • Anthony Jonathan Luistro, Manager MIS Section, Terumo (Phils) Corp,
    Philippines

    The package did exceed my expectations. The CSV package is very comprehensive and complete. The CSV package is a must for every IT Department gearing towards FDA Aligned documents. It is simple but very effective. (Ref 1142)
    .
    Additional Feedback after the FDA Inspection:
    Hello Sir Ludwig,, We have passed the FDA Audit just concluded yesterday.
    Thanks for your SOP and Templates. It help me a lot understand and explain to the auditor our own CSV Procedures. All documents are very helpful.
    Thanks a lot!, Regards,
    ANTHONY JONATHAN LUISTRO MCT, MCITP, CCNP, Linux+ MIS Manager
    MIS Section, Administration Department, Terumo (Phils) Corporation
    (Ref 1142)
  • Ms Alecia Oswald, Manager Information Systems, LVT inc, USA
    The package did exceed my expectations
    . It package has helped me create a CSV system for a company. CSV is an overwhelming concept to begin with, so the primer with step-by-step implementation was great to help determine a starting point. Many packages offer direction without specific SOPs, this package goes above and beyond by offering example SOPs, templates, and plans and the primer to help implement the system. I would *highly* recommend this package to anyone who needs to start a CSV system or even review their current CSV system. The checklists are very valuable tools for making sure that your CSV system will hold up to any audit. (Ref 1048)
  • Mr. Lawrence DeHeer, President, Blaze Systems Corporation, USA
    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. (Ref 1032)
  • Michael Delancy, Quality Systems Engineer, Mylan Pharmaceuticals, USA
    The package did exceed my expectations. Very detailed. Good information. All gathered in one place. Examples and SOP documents very valuable. (Ref 1074)
  • 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. Steve Krueger, Owner, MAK and Associates,, USA
    Material provided was able to reinforce my knowledge of computer system validation and add practical examples. Material provided was a great introduction and hands on tool for me
    , (Ref T-1079)
  • Mr. Jim Dougherty, Sr. Mgr. Software Iron Mountain, IT Software Engineering,  Engineering, USA
    Comprehensive coverage of topics, Excellent examples. (Ref: T-1028)
  • Brian Flaherty, Spectra Laboratories, USA, IT Department
    About the audio seminar Computer System Validation: Step-by-Step:
    The seminar did exceed my expectations. We are preparing for our first FDA audit as our Clinical Research Department has just finished doing clinical trials for a customer who is now going to market with a new drug. Part of this will require an FDA audit of our LAB. About 60 persons in our lab representing all departments attended and all were impressed on the great amount of information that was conveyed in such a short period. The perfect overview of FDA requirements for our company (Ref T1052)

  • Mr. Larry Gayleard, LG Consulting Services, QA Consultant, USA
    About the audio seminar Computer System Validation: Step-by-Step:
    The seminar did exceed my expectations. The seminar provided a comprehensive discussion of Computer System Validation principles,  Thanks Ludwig..I've never been disappointed with one of your seminars
    (Ref T1051)

The author

Picture of Ludwig Huber

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, click here