Regulatory Audits: Strategies for Avoiding Common Audit Triggers

WHITE PAPER 72664 Data integrity: audit trails with ease of review Author Summary Shaun Quinn, Marketing Manager Chromatography Software, Thermo Fisher Scientific Audit Trails are an important regulatory requirement and are a proven effective means of detecting data integrity issues.…

[ WHITE PAPER ] Empower Software Audit Trails and Logs: A guide to the different locations of audit trails in Empower and what information they provide to reviewers INTRODUCTION WHAT IS AN AUDIT TRAIL? Audit trails are considered the key…

[ WHITE PAPER ] Why is Electronic CDS Data a Major Data Integrity Concern for Regulators? Tools and advice on electronic Data Integrity and how it specifically applies to chromatography systems and the challenges they present in audit situations Heather…

[ WHITE PAPER ] The Role of Empower Chromatography Data System in Assisting with Electronic Records Regulation Compliance INTRODUCTION The objective of this white paper is to discuss the 21 CFR Part 111 and EU EudraLex Annex 112 compliance readiness…