FDA Guidance: Data Integrity and Compliance with Drug CGMP, 12/18

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In December, 2018, the CDER, CBER and CVM branches of the FDA published Guidance for Industry, Data Integrity and Compliance with Drug CGMP. This document was written in question and answer format to clarify the role of data integrity in current good manufacturing practice (cGMP) for drugs. This guidance is intended to provide flexible and risk-based strategies to prevent and detect data integrity issues.

This guidance contains clarifications and definitions of the following terms:

• Data Integrity
• Metadata
• Audit Trail
• Static and dynamic record formats
• Backup
• Computer systems

The guidance also provides recommendations regarding:

• Validation scope
• System access restrictions
• Unique user logins
• Audit trail reviews
• Electronic copies of paper records
• Print outs of electronic records
• Laboratory systems and electronic records
• Data falsification investigations
• Data integrity training