21 CFR Part 11 - Steps to take if we want to validate an electronic system


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Can anyone help me determine what are my steps to take if we want to validate an electronic system we put together (for inventory, manufacturing, releases, etc) to make it compliant with 21 CFR Part 11?



Super Moderator
I'd like to add on a bit to the (excellent) response by @William55401. First, to be clear, validation won't make it compliant; validation can only demonstrate compliance. You can effectively glean the requirements from the regulation and demonstrate compliance as part of validation using the previously-indicated guidance.

It sounds like this is a home-grown system and, to be frank, if the developers didn't consider Part 11 in the design, it's pretty unlikely that you can demonstrate compliance. It's not something you can just bolt on.

Alex Kennedy

ERP systems can at times manipulate data that can control or affect the quality, efficacy, safety of drugs or the security of the associated attendant mandated manufacturing records. Where this occurs; validation becomes obligatory. The degree of validation would need to be established using a risk assessment process. If the software were to be assessed as high risk then full life cycle validation becomes mandatory. This is a very precarious and expensive path to venture along.
I would talk it through with your regulators; they are usually very helpful.
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