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Computer Validation

Even though FDA has relaxed some of its expectations regarding 21 CFR Part 11 compliance (see the new guideline), the rules still apply for all critical computer systems.  We can help you determine how to use a risk based approach to prioritize your computer validation projects.  We can also write the Master Plans, protocols, and final reports required.

Step 1 of any Part 11 compliance program is to perform an assessment of your current systems to determine what is needed to bring them into compliance with FDA expectations.  Our experts are current on all the latest trends.  Our assessment reports are thorough and detailed with specific per system recommendations.  We do not take a simple check list approach, but instead determine the aspects of the system that pose regulatory or product quality risk and how to solve those issues.


FDA on Computer Validation

Even if there is no predicate rule requirement to validate a system in a particular instance, it may nonetheless be important to validate the system to ensure the accuracy and reliability of the Part 11 records contained in the system. We suggest that your decision to validate such systems, and the extent of validation, be based on predicate rule requirements to ensure the accuracy and reliability of the records contained in the system. We recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety and record integrity.

Draft Guidance for Industry
Part 11, Electronic Records; Electronic Signatures
Scope and Application February 2003


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