Are You Ready for the Latest Data Integrity Guidance? Part 1: Scope, Data Governance, and Paper Records.

The article reports that the gestation period for the Pharmaceutical Inspection Co-operation Scheme (PIC/S) PI-041 data integrity guidance, and a draft 3 was issued for public comment in November 2018, with the final version issued in July 2021. It mentions that Good Practices for Data Management and Integrity in Regulated od distribution practice (GDP) or good manufacturing practice (GMP) environment with a document number PI-041.