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© 2022 MJH Life Sciences and BioPharm International. All rights reserved.
© 2022 MJH Life Sciences™ and BioPharm International. All rights reserved.
Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).
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.
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.