Are CTMS, CDMS, or EMR/EHR systems subject to 21 CFR Part 11?

Is 21 CFR Part 11 applicable to Clinical Trial Management Systems (CTMS), Clinical Data Management Systems (CDMS), Electronic Medical Records (EMR), or Electronic Health Record (EHR) systems?

In determining if 21 CFR 11 applies to a system, regardless of its type, two factors need to be considered: the intended use of the system and whether electronic records/signatures will serve as the official records in lieu of paper records. If the generated electronic records within the system will be considered the official records for regulated activities, then compliance with 21 CFR Part 11 is necessary.

A GxP assessment of the system should be performed to determine its GxP compliance, and if applicable, assess whether compliance with 21 CFR Part 11 is necessary. Given the nature of a CDMS, it is likely both GxP compliant and required to comply with Part 11.