Strengthen Spreadsheet Controls. Reduce Compliance Risk. Spreadsheets remain one of the most widely used tools across pharmaceutical operations, supporting everything from laboratory calculations and stability programs to equipment maintenance, quality systems, and product release decisions. […]

The Data Integrity Working Group of Rx-360 members has generated an addendum to the previously issued GMP Audit Manual, Data Governance and Data Integrity which provided an approach for GMP auditing and self-assessment of pharmaceutical […]

This data integrity audit manual provides an approach for GMP auditing and self-assessment of pharmaceutical manufacturers, contract manufacturers and laboratories for data integrity and data governance elements. The scope includes the manufacture and testing of […]