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 […]

Quality Agreements (QAs) have become an essential tool to define quality and regulatory responsibilities between participants of the pharmaceutical supply chain. Especially in regulated environments, QAs form a crucial part of the supplier qualification process. […]

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 […]

About: This tool has been developed in excel document: Tab 1: Cause and Effect Matrix Tab 2: Failure Mode and Effects Analysis. Background of Template: The template was designed to compliment the Upstream Supply Chain […]

About: This tool allows you to map your supply chain. The template has been developed in word document so that you can summarize the material handling steps from manufacture to owner: List each party involved, […]