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.
Julie Lippke
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Julie Lippke, analytical research and development at Pfizer Inc., Groton, CT
Articles by Julie Lippke
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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Latest Updated Articles
A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewPublished: September 2nd 2022 | Updated:
Assessing Data Integrity Risks in an R&D EnvironmentPublished: August 2nd 2020 | Updated:
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingPublished: August 2nd 2021 | Updated:
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