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 […]


Supplier Assessment Questionnaire

January 19, 2021

Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment questionnaire. Suppliers routinely exhaust valuable resources continuously completing […]

Guide: Best Practices for Quality Agreements Version 2.0

April 17, 2018

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. […]

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 […]

Templates & Tools

Upstream Supply Chain Security Risk Assessment Tool

June 14, 2014

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 […]

Supply Chain Mapping Spreadsheet

April 14, 2014

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, […]