Templates & Tools

Selection and GMP Auditing of Software and Hardware Vendors

December 7, 2022

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 […]

Interactive Resources
Templates & Tools

GMP Audit Manual – Data Governance and Data Integrity

March 27, 2018

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 […]