News|Articles|September 25, 2026

Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 2: Practical Considerations for CGMP Documentation Systems

This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.

In Part 1 of this article, the regulatory framework, inspectional findings, and governance considerations for master production and control records (MPCRs) and batch production and control records (BPCRs) were evaluated, including the role of standardized templates and spreadsheet-based systems in supporting data integrity and compliance. Part 2 focuses on risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.

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