FileHold DMS 21 CFR Part 11 Compliance

Monday, November 5, 2012

Recently we've had some customers ask us how FileHold document management software is compliant with the US Food and Drug Administration 21 CFR Part 11. Due to this interest, FileHold produced a 21 CFR Part 11 white paper that you can read or download the PDF version.

The Food and Drug Administration (FDA) 21 CFR Part 11 regulation defines the criteria under which electronic records and electronic signatures are considered to be a trustworthy equivalent to paper records. 21 CFR Part 11 provides guidelines and regulations related to copying, permissions, audit logs and tracking, version control, and the application of electronic signatures to electronic documents in the United States.

There are advantages to using electronic records both for the industry and the FDA. In addition to being more cost effective, the approval process should be shorter and access to documentation is faster. Electronic records have significant advantages over paper records such as lower space requirements and easier retrieval of information. The reality of today's computer driven world, the use of electronic records as cannot be avoided, for example in analytical laboratories for automated data acquisition and evaluation. In this case the laboratories “must” comply with Part 11.

If you're looking for document management software, see what FileHold has to offer to help you comply with 21 CFR Part 11.