21 CFR Part 11 is an FDA guideline that discusses
the use of electronic systems for record keeping. With paper systems,
sheets of paper were literally signed by the author or person modifying
or submitting information. With an electronic system, obviously
signing the information can't be done in the same way. 21 CFR Part
11 discusses how an electronic system needs to be used in order
to ensure the data within the system has integrity.
21 CFR Part 11 details out some specific required features of electronic
systems. Some examples are unique user IDs and passwords, audit
trails, process documentation, and of course, validation. IRMS has been built to enable 21 CFR Part 11 compliancy, meaning that our software has all of the specific requirements the FDA identified This also
means IRMS can be validated. |
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IRMS
21 CFR Part 11 Compliance:
- The system shall require password changes
on a periodic basis, configurable by the client.
- The system shall display the identity of
the user currently logged into the system on the screen at all
times.
- The system will provide a complete audit
trail of all modifications made to IRMS Cases including: original
field value, changed value, time and date of change, identity
of user who made the change, and optionally, a reason for each
change.
- The system can prevent modifications to
cases once cases have been completed.
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