API | Data Integrity | GxP
Practical Risk-based Guide for Managing Data Integrity in APIs manufacturing
After defining which business processes are cGxP relevant the next phase is to map them in detail. The following steps are performed: A. Identify the systems (both paper and electronic) involved in the processing of cGxP data B. Define individual cGxP data elements C. Identify cGxP data elements that can be modified, deleted, or…