22-24 February 2023
In recent years, regulatory authorities have been struggling with data integrity issues. In particular the U.S. American FDA has tightened the awareness regarding the topic in many Warning Letters. In the meantime, data integrity has also become a focus of European regulatory authorities' inspections. One of the first regulatory authorities to publish a "GMP Data Integrity Definitions and Guidance for Industry" in January and March 2015 was the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). More information can be found in "MHRA revises its Guideline on Data Integrity in the short Term". The contents of this Guidance led to a number of discussions and activities within the industry. Not all the requirements were considered appropriate. Just recently, the Agency has published a new version of the document entitled "GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation July 2016".
The basic structure of the Guidance has been largely maintained both in the introduction and the definitions part. Primarily, the changes made concern new formulations and a few new term definitions. The following terms have been newly added:
7. Data transfer / migration.
8. Data processing.
9. Recording data.
10. Excluding data.
14. Electronic signatures.
20. Cloud providers and virtual service / platforms (also referred to as software as a service Saas / platform as a service (PaaS / infrastructure as a service (Iaas).
A News about the detailed content differences will be issued soon.