Data Integrity for Your Laboratory Computerized Systems

[ WHITE PAPER ] A Basic Overview: Meeting the PIC/S Requirements for a Computerized System Lynn Archambault Waters Corporation, Milford, MA, USA INTRODUCTION The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) provides good manufacturing…

[ 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…

Data Integrity in Pharmaceutical Quality Control Laboratories: What You Need to Know Whitepaper Author Loren Smith, Agilent Technologies, Inc. Santa Clara, CA USA Data integrity problems in pharmaceutical quality control laboratories are driving more regulatory action than ever before. What…

[ 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…