January 26, 2016

Audit Trail

With InstantGMP™, you can see a complete audit trail anytime, from anywhere.

Audit Logs are essential for maintaining compliance with 21 CFR part 11 Electronic Documentation and Electronic Signatures.

Part 11 includes this requirement: "Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation."

The InstantGMP™ electronic batch record and electronic device history record software maintain an on-line, real-time audit log to record when every screen is accessed, when any data is entered and the name of the person making the change to the system documentation. This is part of the InstantGMP™ commitment to maintaining compliance with GMP, FDA and ISO requirements for electronic records and for software validation.