
What is FDA 21 CFR Part 11 Compliance?
The United States Food and Drug Administration (FDA) issued regulations Title 21 Code of Federal Regulations Part 11 in 1997 and enacted relevant industry guidelines in 2003 to refine the rules. It provides criteria for acceptance of electronic records, signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. Part 11 applies to any record governed by an existing FDA predicate rule that is created, modified, maintained, archived, retrieved, or transmitted using computers and /or saved on durable storage media.
21 CFR Part 11 is widely accepted and implemented by biomedical companies, hospitals, research institutes and laboratories in the United States. Since issued, it has spread around the world. Although not mandatory, it is generally accepted and used in Europe and Asia. Any pharmaceuticals, biomedical related equipment, or information systems exported to the United States should comply with 21 CFR Part 11 regulations, which if violated, can deprive the exporter by the FDA of its right to sell goods to the United States.
