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.
Katria Harasewych
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Katria Harasewych works in quality at Merck & Co., Inc. (Kenilworth, NJ).
Articles by Katria Harasewych
A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
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Assessing Data Integrity Risks in an R&D EnvironmentOctober 1st 2020
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