Summary

Data Integrity Working Group Charter

Author:

Data Integrity Working Group

The Data Integrity Working Group of Rx-360 focuses on an area that has been the subject of US FDA enforcement actions for at least the past 15 years. In the past few years, enforcement actions by other global health authorities is now publicly available.

Regulatory authorities continue to identify companies with deficiencies in this area even though global health authorities have published regulations and requirements in the field and enforcement action details are publicly available. We intend to support the stakeholders in Rx-360 in addressing these areas within their firms by maintaining a library of regulations/guidance, health authority presentations and publications, and industry trade group publications and presentations.

We will leverage our collective expertise and experience in the areas of data governance and data integrity by developing tools and educational materials for use by Rx-360 auditors and member companies in implementing these programs within their firms. These same tools will be valuable for suppliers of raw materials because they are expected to have adequate data governance programs in place.