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21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Compliance with U.S. Food and Drug Administration (FDA) 21 CFR Part 11 is essential for regulated companies using electronic records and signatures.

If your company stores GMP data electronically then the Application or Computer system used to acquire, manipulate and store that data must be validated, and you must demonstrate that the system or application operates in compliance with the Electronic Records and Electronic Signatures requirements of the 21 CFR Part 11 Regulation.


CSV has over 15 year’s experience designing and validating computer systems to comply with this regulation in the life sciences industry.

We would be delighted to advise you on the regulation and the required validation testing necessary to comply with this regulation. Please get in contact for further details.

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