21 CFR Part 11, March 1997

21 CFR Part 11 Electronic Records; Electronic Signatures Issued in March 1997 and effective in August of 1997 this regulation applies across all divisions of the U.S. FDA. It applies to all computer systems and software used for electronic record keeping and electronic signatures for records required by the FDA regulations. Some of the key issues associated with this regulation that each company must carefully consider are the lack of grandfathering of old systems, the exact scope of what is considered to be an electronic record, and provisions for electronic audit trails. While some assume that if hard-copy is printed from a computer system then the system is not within the scope of this regulation — this is not, however, consistent with FDA’s position. As of late 1999 FDA has given several indications that will be in ramping up enforcement of this regulation shortly.

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