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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
June 01, 2003
This article examines the application of 21 CFR Part 11 to those areas of research and development (R&D) where compliance is not strictly required and the response of R&D equipment vendors to the rule's requirements and customer needs. The case is presented that vendors must accept that understanding and meeting Part 11 requirements is now part of their business environment.