Start 21cfr part 11 is used for validating records

21cfr part 11 is used for validating records

ICH also issues industry best practices for validation. Ofni Systems is an industry-recognized leader in computer validation.

In practice, the requirements on access controls are the only part routinely enforced.

If a regulated firm keeps "hard copies" of all required records, those paper documents can be considered the authoritative document for regulatory purposes, and the computer system is not in scope for electronic records requirements—though systems that control processes subject to predicate rules still require validation.

Firms should be careful to make a claim that the "hard copy" of required records is the authoritative document.

The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application) but not to paper submissions by electronic methods (i.e., faxes).