What software features are necessary to be 21 CFR Part 11 compliant?
An audit trail shall be implemented that allows a means to reconstruct data modification.
The audit trail shall include: the name of the user that made the entry, what was changed (not obscuring the original value), the date and time of change and the reason for change.
Electronic Signatures/Digital Signatures
If electronic signatures will be used, they must include the following:
Note: An electronic signature consists of two components: id code (username) and password. This is different than the initial login to the software.
Users must have the ability to obtain meaningful data from the software.
The software shall be designed in such a way that a logical process workflow is incorporated (i.e. you are unable to approve until all required pieces are completed).
Data must be backed up on a regular basis
Standard Operating Procedures
Training should be documented to verify that only trained individuals are using the software.
A quality validation methodology shall be used to ensure the system (software, people, etc) is performing as intended. It is important to understand that you are validating a SYSTEM and not just the software.
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last modified October, 2013
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