
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 works in quality at Merck & Co., Inc. (Kenilworth, NJ).
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.
A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
Published: October 1st 2020 | Updated: