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.
Joseph Mongillo
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Joseph Mongillo works in analytical research and development at Pfizer
Inc. (Groton, CT).
Articles by Joseph Mongillo
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
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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