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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
- 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 [...]
- Subjects :
- Good manufacturing practice -- Methods
Data security -- Management
Risk assessment -- Methods
Pharmaceutical industry -- Quality management -- Accounting and auditing -- Information management
Company business management
Company systems management
Data security issue
Business
Pharmaceuticals and cosmetics industries
Subjects
Details
- Language :
- English
- ISSN :
- 15432521
- Volume :
- 46
- Issue :
- 9
- Database :
- Gale General OneFile
- Journal :
- Pharmaceutical Technology
- Publication Type :
- Periodical
- Accession number :
- edsgcl.719993190