System Security-21 CFR, Part 11

CA Recorder features a password system that is compliant with the directives of 21 CFR, Part 11. The system administrator controls system access by assigning temporary passwords with the CARADMIN security program.

Audit Trails-Electronic Signatures

The system automatically tracks all system access and every significant action that an operator takes during the set up and performance of an experiment. These actions are logged by time and date of occurrence into a secure audit file. Critical files are time stamped with the operator’s electronic signature. These files are secure, in that they are binary read-only files that cannot be altered or modified by ordinary means.