How to Prepare a Computer System Validation Protocol?

Learn to write a computer system validation protocol

 

Learn how to write a (CSV) Computer System Validation Protocol according to the System Development Life Cycle (SDLC).

Either you create your own installation qualification or operational qualification protocol or use a template, they may include, but, is not limited to the following sections and information, (as applicable)

1.0   Approvals.

2.0   Purpose.

            2.1    Scope.

3.0   System Description.

4.0   Responsibilities.

5.0   Abbreviations and Definitions.

6.0   Documentation Requirements.

7.0   General Procedure.

             7.1           General Description (Methodology)

             7.2           System Architecture.

             7.3           General Methodology.

             7.4           Acceptance Criteria.

             7.5           Deviations.

             7.6           Training Record/Signature Log.

             7.7           Test Instruments Calibration.

             7.8           Supporting Documentation.

             7.9           Final Report.

8.0   Installation Qualification.

            8.1           IQ Test 1: Manuals and Documentation Verification.

           8.2           IQ Test 2: Software Licensing Verification.

           8.3           IQ Test 3: Equipment/System Component Verification.

           8.4           IQ Test 4: Electrical Power Supply Utilities Verification.

           8.5           IQ Test 5: Platform Software Installation Verification.

           8.6           IQ Test 6: Controlled Procedure, Work Instruction & Specifications Verification.

           8.7           IQ Test 7: System Minimum Requirements Verification.

           8.8           IQ Test 8: Environmental Conditions Verification (Server Only)

           8.9           IQ Test 9: Network and Communication Verification.

          8.10         IQ Test 10: Equipment General Condition Verification.

           8.11         IQ Test 11: IQ Completion Checklist.

9.0   Operational Qualification.

          9.1           OQ Test 12: Standard Operating Procedures Verification.

          9.2           OQ Test 13: Software and Application Version and Back-Up Verification

          9.3           OQ Test 14: Power ON/OFF Verification

          9.4           OQ Test 15: Interference Verification.

          9.5           OQ Test 16: Communication Loss Verification.

          9.6           OQ Test 17: System Response to Power Failure or Interruption.

          9.7           OQ Test 18: Application Access Verification.

          9.8           OQ Test 19: New User Creation Access Verification.

          9.9           OQ Test 20: Concurrent User Verification.

          9.10         OQ Test 21: Creating and Editing a User Account.

          9.11         OQ Test 22: Sequence of Operation, and Audit trail Verification.

          9.12         OQ Test 23: Reports Verifications.

10.0       Attachments.

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For more details on specific FDA expectations and how to perform a Computer System Validation protocol, follow us.

validation templates online

Three (3) Options to Create a Computer System Validation Protocol:

Option 1. You Can Create a CSV Protocol, using a Template.

You can download samples of the validation templates in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.

Option 2. We Can Bring You a Formal Training on How to Perform Computer System Validation Using Our Template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We Can Create a Customized Computer System Validation Protocol.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

References: Computer System Validation Protocol

https://www.fda.gov/media/73141/download

Food and Drug Administration References

  1. Glossary of Computerized System and Software Development Terminology (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, FDA 1995)
  2. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (FDA, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002)
  3. Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices (FDA, Center for Devices and Radiological Health, 1999)
  4. Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-Based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems ApproachExternal Link Disclaimer (FDA 2002)
  5. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1

Industry References

  1. The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)
  2. ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000)
  3. ISO 14971:2002 Medical Devices- Application of risk management to medical devices (ISO, 2001)
Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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