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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Katria Harasewych, quality, Merck & Co., Inc., Kenilworth, NJ
September 02, 2022
The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
August 02, 2020
A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.