21 CFR Part 11 Compliance in MES: Electronic Signatures and Data Integrity

In pharmaceutical manufacturing, compliance with 21 CFR Part 11 is critical for ensuring the integrity of electronic records and signatures within Manufacturing Execution Systems (MES). This paper proposes a comprehensive framework for implementing electronic signatures and data integrity controls in MES, aligning with 21 CFR Parts 11, 210, 211, ICH Q7, and EudraLex Volume 4 Annex 11. The methodology includes system design, user access controls, audit trails, and data lifecycle management, validated through risk-based assessments. Key findings demonstrate that tailored electronic signature configurations (none, single, or double) based on process criticality reduce compliance risks while enhancing operational efficiency. Automated data capture and true-copy transmission further ensure data integrity. Challenges such as manual data entry and generic account usage are addressed through procedural and technical controls. This study underscores the importance of data integrity by design, offering practical guidance for pharmaceutical manufacturers to achieve regulatory compliance and safeguard patient safety.