Quality & Compliance
Annex 11 2011 Version vs. Annex 11 2025 Draft Version: What are the Differences and Enhancements?
The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended that the current version of Annex 11 on Computerised Systems be revised to reflect changes in regulatory and...
Quality & Compliance
How Mature Are Your Data Integrity Practices? New FDA and EU Regulatory Focus Areas
Data integrity has been in regulators' spotlight for decades, and the expectations for ensuring data integrity are evolving and increasing. This is partly because of the various Data Integrity...