Definition
FDA 21 CFR Part 11 is a United States regulation setting criteria under which electronic records and electronic signatures are treated as trustworthy, reliable and generally equivalent to paper records and handwritten signatures.
Human Explanation
It establishes expectations for regulated systems that create, modify, maintain, archive, retrieve or transmit electronic records.
Why it Matters
It supports confidence that regulated electronic records are reliable, complete and appropriately protected.
Conceptual Boundary
Part 11 does not prescribe one technology or replace the underlying FDA requirements that make a record subject to regulation.
Practical Perspective
Applicability and current obligations should be verified against the official regulation and relevant FDA guidance before defining controls or Validation scope.