Why is Electronic CDS Data a Major Data Integrity Concern for Regulators?

C10G-E071 WHITE PAPER What you should know to assure laboratory data integrity with LabSolutions In order to assure data integrity in life sciences industry laboratories it is necessary to address procedural, behavioural and technical controls. While it is regulated companies…

[ 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 ] Data Integrity for Your Laboratory Computerized Systems Lynn Archambault, Informatics and Regulatory Compliance Product Marketing Manager, Waters Corporation INTRODUCTION Electronic data and computerized systems introduce new challenges to maintaining data integrity. With increased scrutiny from regulatory…

[ 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…