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.
Thomas Cullen
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Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).
Articles by Thomas Cullen
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
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingPublished: July 16th 2021 | Updated:
Assessing Data Integrity Risks in an R&D EnvironmentPublished: October 1st 2020 | Updated:
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