21 CFR Part 11
Also: Part 11
The FDA regulation setting the conditions under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records and handwritten signatures.
Part 11 applies whenever an electronic record is used to satisfy a predicate GxP rule. It covers audit trails, electronic-signature components, record integrity, access control and the ability to produce copies for inspection.
In logistics it reaches shipment approvals, proof of delivery and excursion dispositions, not just laboratory and quality systems.
Related terms