Compliance Laws – FDA 21 CFR Part 11
FDA 21 CFR Part 11 (The Food and Drug Administration )
This legislation was enacted by The Food and Drug Administration (FDA) in 1997 and enforced beginning in 2000. It governs the use of electronic signatures and electronic records by pharmaceutical manufacturing companies. It aims to insure that electronic media provide the same level of data integrity as the paper-based storage and retrieval systems they are increasingly replacing. It mandates that:
- For electronic signatures to be considered the legal equivalent of handwritten signatures, they must be secure, unique, and verifiable. Electronic signatures generally consist of a user name and password, which are tied to a specific computer.
- For electronic records to be accepted by the FDA, they must provide an inclusive audit trail that is computer-generated, operator-independent, time-stamped, and secure. The audit trail must preserve the total sequence of electronic events: record changes can not overwrite previous information. From the time a file is created, all additions, deletions, and changes must be saved in such a way that they can be retrieved and reviewed at a later time, and they must be traceable to the individuals who initiated them and who can be held responsible via their electronic signatures.
Athena Archiver assists companies in complying with FDA CFR Part 11 in the following ways:
- Provides unique electronic signatures
- Provides a secure, time stamped audit trail