Title 21 CFR Part 11 of The Code of Federal Regulations
The Food and Drug Administration (FDA) guidelines regarding electronic records and electronic signatures in the United States are regulated under Title 21 CFR Part 11 of the Code of Federal Regulations. Commonly referred to as CFR Part 11, it defines the criteria under which electronic records and electronic signatures are considered to be reliable, trustworthy and equivalent to paper records.
CFR Part 11 requires drug makers, biotech companies, medical device manufacturers and most other FDA-regulated industries to implement audit controls and trails, system validations, electronic signatures and documentation for software and systems involved in the processing of electronic data that are required to be maintained by the Food and Drug Administration predicate rules, or used to demonstrate compliance to a predicate rule.
This rule also applies to submissions made to the Food and Drug Administration in electronic format but not to paper submissions by electronic methods. Specifically, it does not require the 21CFR1 requirement for record retention for tracebacks by food manufacturers. Most food industries are not explicitly required to keep such detailed records, however, electronic documentation kept for HACCP and similar requirements must meet these requirements.
In practice, the requirements on access controls are the only part that is routinely enforced. The "predicate rules" which required the records to be kept in the first place are still in effect. If electronic records are illegible, inaccessible, or corrupted the manufacturers are still subject to those requirements.
If a regulated organization keeps hard copies of all required records, the paper documents can be considered to be the authoritative document for regulatory purposes and the computer system need not meet these requirements.
Companies should be careful to make a claim that hard copies of required records are authoritative document. In order for the hard copy produced from its electronic source be considered as the authoritative document, the hard copy must be a complete and accurate copy of its electronic source and be used exclusively for regulated activities. The current technical architecture of computer systems increasingly makes the burden of proof for the complete and accurate copy requirement extremely high.
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