DECODING 21 CFR PART 11

The 21 CFR Part 11 was effected in 1997 by the US Food & Drug Administration (FDA) to encourage wider use of electronic data technology. With predicate regulations such as GMP, GLP and GCP as its base, Part 11 delineates a set of criteria to implement control, validation and audit trail on electronic data that are meant to replace written documents as equivalents. Although necessary to preserve data integrity, Part 11 remains one of the most challenging regulations imposed by the FDA on the biotechnological and pharmaceutical industries, directly affecting all systems that generate, store and use electronic data which fall under the predicate regulations. In August 2003, after gathering significant industry feedback, FDA released the guidance draft ?Industry Guide, Part 11, Electronic Records; Electronic Signatures ? Scope and Application?. Through this scope and Application Guide, the agency announced a narrowed scope of Part 11 with enforcement discretion exercised on items such as computerised systems validation, time-stamped audit trails, and methods used to reproduce and retain electronic records. This guide remains relevant today, pending a revised version of the Part 11 regulation to be released by FDA.