FDA published the Guidance for Industry Data Integrity and Compliance with cGMP

-FDA finalized the guideline of data on Data Integrity and Compliance with Drug CGMP (Questions and Answers Guidance for Industry). The guideline is effective from December 2018.

-The draft guideline for the same is published on April 2016 which is finalized and now effective.

-Data integrity is critical throughout the CGMP data life cycle, including in the -creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the data’s life cycle.

-The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212.

-Her the PDF copy of guideline available:  Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry