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

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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 a risk-based approach to ATR where ATR is only required for high impact GxP (good manufacturing practices [GMP] and good laboratory practices [GLP] for the purposes of this paper) analytical data and possible system security changes. This approach requires a fully documented risk assessment that encompasses the technical controls and identification of data impact. Note that while analytical data are the focus of this paper, the principles outlined may be applied to other activities.

Read this article in BioPharm International’s November Manufacturing and Facilities 2022 eBook.

About the authors

Julie Lippke* and Joseph Mongillo both work in Analytical Research and Development at Pfizer Inc. (Groton, CT); Thomas Cullen and Christian Metz both work in Analytical Research and Development at AbbVie Inc. (North Chicago, IL and Ludwigshafen, Germany, respectively); Katria Harasewych works in Computer System Validation Quality, CoE at Merck & Co., Inc., (West Point, PA); Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium. All contributors are part of the IQ Working Group.

Article details

BioPharm International
eBook: Manufacturing and Facilities
November 2022
Pages: 24–29

Citation

When referring to this article, please cite it as J. Lippke, et al., “A Harmonized Approach to Performing a Risk-Based Audit Trail Review,” BioPharm International's Manufacturing and Facilities eBook (November 2022).