Computer Validation

Computer Validation to Part 11

Computer Systems Validation

Achieving and maintaining compliance with applicable GxP regulations such as FDA 21 CFR Part 11, GAMP5 and fitness for intended use by:

the adoption of principles, approaches and life cycle activities within the framework of validation plans and reports
The application of appropriate operational controls throughout the life of the system

Our 21 CFR Part 11 Approach

We propose a 2 phase approach with our customers.

In phase 1, we audit the computer system or software to determine if validation is necessary. We complete a gap analysis against the reference documentation:

  1. US FDA: Code of Federal Regulation 21 CFR Part 820 Medical Devices Quality Systems Requirements
  2. US FDA: General Principles of Software Validation; Final Guidance for Industry and FDA Staff
  3. US FDA: Code of Federal Regulation 21 CFR Part 11 Electronic Records; Electronic Signatures
  4. US FDA: Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application
  5. ISPE: GAMP 5 A Risk Based Approach to GxP Compliant Computerized Systems.

(GAMP: Good Automated Manufacturing Practice)

Our 21 CFR Part 11 Computer Validation Deliverables

We will produce a report and present our findings back to you. The next step is your decision. You may be able to justify the decision not to validate. The report will clearly outline what aspects of the system need computer systems validation or if a procedure would suffice. If may not need to be validated at all. If so, the decisions are justified and documented.

If validation of the computer systems is necessary, a phase 2 is executed. We can do computer system validation for you or direct your software validation engineers as to what needs to be done. We can supply you with the templates you need.

Contact us for further information on what we can do for your organisation.


Phone: +353 (0)21 240 6250

© 2020 Velopi : PMBOK, PMI and the R.E.P. logo, PMP, PgMP, CAPM, PMI-SP and PMI-RMP are registered marks of the Project Management Institute, Inc.

Web Development by Granite Digital