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Harmonized Approach to Performing a Risk-Based Audit Trail Review: 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

Authors :
Lippke, Julie
Mongillo, Joseph
Cullen, Thomas
Metz, Christian
Harasewych, Katria
Benamira, Fouad
Source :
Pharmaceutical Technology. September, 2022, Vol. 46 Issue 9, p48, 5 p.
Publication Year :
2022

Abstract

Audit trail review (ATR) is a mechanism to detect potential critical changes to data/system security settings and to ensure the quality and integrity of reported data. The authors have defined [...]

Details

Language :
English
ISSN :
15432521
Volume :
46
Issue :
9
Database :
Gale General OneFile
Journal :
Pharmaceutical Technology
Publication Type :
Periodical
Accession number :
edsgcl.719993190