My continuing adventure with 21 CFR Part 11 - the evolution of Zymark's compliance

A renewed focus has been given to the 3-year-old regulation 21 CFR Part 11, Electronic Records and Electronic Signatures. This paper gives a chronology of the process of an equipment vendor, Zymark Corporation, validating laboratory automation equipment for compliance to the regulation 21 CFR Part 11. Zymark's Tablet Processing Workstation II™ (TPW™) and Prelude™ are the instruments chronicled. The first instrument, the TPW™, was developed before Zymark defined its strategy on how to meet its customer's need for 21 CFR Part 11 compliant equipment. The TPW™ has been available for several years, and in the summer of 1999 it received a major software upgrade to improve its security. The second instrument, the Prelude™, is a new product. It had a design requirement to meet the regulation. Zymark's Part 11 strategy was already in place and used for this development project. This chronology will include all aspects of the exercise, including familiarization with the standard, development of the protocols, review of the protocols by industry experts, review of the protocols by pharmaceutical users, execution of the tests, preparation of the exception reports, and the release of any necessary product revisions.