- According to the FDA, FDA Part 11 pertains to the legality of all records existing in electronic or digital form and used in place of records kept on paper (hard copy). FDA Part 11 covers the creation, ongoing maintenance, modification, storage, retrieval from storage and/or transmission of these electronic records. It also oversees the legality of electronic and digital signatures which are used in place of handwritten signatures on paper.
- Businesses which must comply with FDA Part 11 are all FDA-regulated industries. They include pharmaceutical manufacturers, biological and gene research and manufacturing, bio-technology companies and manufacturers of medical devices.
- Compliance, and enforcement of compliance involves the FDA overseeing the proper validation of all electronic records, maintaining a clear history of all audits, known as an "audit trail," and the retention and copying of electronic records as required, according to the FDA.
- Other compliance issues required by FDA Part 11 include access to electronic records by authorized personnel only and a system of checks and controls on the use of electronic and/or digital signatures.
- FDA Part 11 was revised by the FDA as of April 1, 2010, after industry-wide concerns were raised that compliance with some aspects of FDA Part 11 created problems in innovation and slowed technical advances in electronic record-keeping. A period of inspection and study of FDA Part 11 and related industries by the FDA resulted in revised FDA Part 11 compliance procedures, according to the FDA.
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