Does 21 CFR 11 apply to a CTMS (clinical trial management system), CDMS (clinical data management system), EMR (electronic medical record), or EHR (electronic health record) system?
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 the type of system. 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. Based on the nature of a CDMS, it is most likely going to be both GxP and required to comply with Part 11.