Is a web-based quality management system that includes document control and CAPA modules required to be 21 CFR Part 11 compliant?
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The answer depends on a couple of factors:
- How you intend to use the system
- Whether paper or electronic records/signatures will be considered the official records
If the electronic records that are generated, contained, and/or approved in the system pertain to regulated activities and are going to be considered the official records (i.e., used instead of paper records), then we would say the answer is “yes.”
We suggest that you perform a GxP assessment on the system and then, if it is indeed GxP, evaluate whether it is also subject to 21 CFR Part 11. Due to the nature of a QMS, our hunch is that it is most likely both GxP and required to comply with 21 CFR Part 11.