GxP Data Integrity Assessment – Alarm Acknowledgement User Details Missing from Audit Trail.
1. Executive Summary During review of the computerized system audit trail, it was observed that the Alarm Acknowledgement event does
Data Integrity
Requalification, Change Control, and Lifecycle Management
Managing Equipment Changes While Maintaining GMP Compliance and the Validated State Series: Part 12 of 20 Introduction Equipment qualification is
Data Integrity in the Pharmaceutical Industry
Introduction In the highly regulated pharmaceutical industry, data is one of the most valuable assets. Every manufacturing activity, laboratory analysis,