White Paper: Application Of Electronic Records & Signatures In Calibration Management Software

Effective August 20, 1997, the Food and Drug Administration (FDA) issued 21 CFR Part 11, setting forth criteria under which the agency will accept, under certain circumstances, electronic records and electronic signatures as equivalent to paper records and handwritten signatures. Part 11 allows firms to take advantage of electronic technology, and to have electronic records considered equivalent to traditional paper records.