21 CFR Part 11
Field Level Audit Trail and Strong Password Protection
What does a security system have to do with a federal regulation like 21 CFR Part 11? Plenty.
The FDA guidelines set forth the rules for acceptability and use of electronic records and signatures in lieu of “paper” records and “handwritten” signatures. That includes all personnel records in your security system.
So, how do you ensure that all security clearance changes, expiration date modifications, and new administration privileges are tracked to the FDA standard? And, how do you ensure that only authorized personnel can make those changes in the first place?
Field-level Audit Trail in C•CURE 800/C•CURE 9000 helps to ensure the integrity of data by creating a detailed audit trail of all additions, modifications, and deletions of personnel data.