Is a web-based training system required to be Part 11 compliant?
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
The answer is basically the same for any system, regardless of whether it’s web-based or installed in-house. You need to consider these two 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. If the training system will house the official records that document the qualifications of the resources who perform GxP functions, it is most likely both GxP and required to comply with 21 CFR Part 11.