Practical Applications of Data Integrity and Audit Trail Review
Robert Lutskus
Wednesday, December 4, 2019
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Chapters
Introduction
Practical applications of data integrity and audit trail review
ALCOA+
21 CFR Part 11 Subpart B Sec 11.10 Controls for Closed Systems
GAMP 5 Guidance
System audit trail
Data audit trail
Bad audit trail
Ugly audit trail
Good audit trail
Audit trail review
System review and remediation
Periodic review
Summary
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