Overview
Welcome to the Data Integrity Working Group
Failures in data governance and data integrity have plagued the industry for over 15 years. The US FDA, European inspectorate, and WHO have enforced such actions in the US and Europe including countries such as India, China, and Japan. The industry does not appear to have fully met the data integrity requirements and expectations. The Rx-360 Data Integrity Working Group will develop processes, tools, and training to incorporate data integrity best practices.
If you are interested in joining this Working Group please contact us at info@rx-360.org
Rx-360 Vendor Questionnaire Quality System
Selection and GMP Auditing of Software and Hardware Vendors
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 […]