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EU Annex 11 Exit Strategy: Ensuring Business Continuity in Regulated Systems thumbnail
Regulatory Compliance

EU Annex 11 Exit Strategy: Ensuring Business Continuity in Regulated Systems

The revised EU Annex 11 introduces enhanced requirements for exit strategies, ensuring pharmaceutical companies maintain control over their critical GMP data throughout the entire system lifecycle.

September 7, 2025
True Copy Verification: ISPE Best Practices for Paperless Validation thumbnail
Digital Validation

True Copy Verification: ISPE Best Practices for Paperless Validation

ISPE's best practices for true copy verification provide a framework for organizations to confidently move away from paper-based systems while maintaining regulatory compliance.

September 7, 2025
ALCOA++ Principles: Building Data Integrity into Digital Systems thumbnail
Data Integrity

ALCOA++ Principles: Building Data Integrity into Digital Systems

The revised EU Chapter 4 explicitly incorporates ALCOA++ principles as the foundation for data integrity in pharmaceutical manufacturing.

September 7, 2025