Software Improves Compliance with Part 11
To provide the FDA with documented evidence that your system is Part 11-compliant, there are a set of system-specific standard operating procedures (SOPs) you can take to support your validation documents in case of an audit.
21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable and authentic. Implementing software for audit management maintains a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record, when the action occurred, and the changes made to the record.
Audit management software tracks all changes made to every document. Every time a change is made to any field, a user must enter a reason for the change. This information is available on the field level audit report. This field level tracking capability includes the following: remembering old field values, date the change was made, time the change was made, person making the change, and reason for change. This way, in case of an audit, an electronic trail is there to explain every step.
