By 2026, the updates to Chapter 4 and Annex 11, along with the introduction of Annex 22, will bring about a significant ...

One approach that a pharmaceutical company can follow to maintain sound data integrity and overall GMP program is to embrace best practices for data acquisition, data storage, and access controls ...

Twenty years ago, the fraud at Able Laboratories was uncovered. A chromatography data system (CDS) was at the center of the ...

This article provides detailed analyses of Annex 11 revision and the applicable clauses of Chapter 4 that impact computerized ...

In this article, Sartorius demonstrates its solutions to ensure data integrity when optimizing lab digitalization. It touches upon common data integrity violations, avoiding them and how to ...