How to determine the extent of Computer validation to be compliant with 21 CFR part 11

by admin on June 22, 2011

The Section “11.10 Controls for closed systems” of 21 CFR part 11states that,
(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

The question is How to to determine the extent of validation required to be compliant with 21 CFR part 11. Is it the full validation required or only the validation of features which are required for intended use.

I like to put my query with a basic example of simple Computer system validation. Is it necessary to validate all the hardware and software in the Computer to be compliant with the 21 CFR part 11 or only the intended hardware and software validation will serve the purpose of achieving the compliance of 21 CFR part 11.

#SQASolutionShare on FacebookShare on Google+Share on LinkedInTweet about this on TwitterEmail this to someone

Previous post:

Next post: