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Pharmaceutical Calibration: Meeting FDA 21 CFR Part 11 Requirements
Source: | Author:Olivia | Published time: 2025-03-14 | 15 Views | Share:

Keywords: FDA compliance, audit trails, GMP calibration

In pharma, calibration isn’t just about accuracy—it’s about data integrity. Critical FDA-aligned strategies include:

  • Electronic Signatures: Secure user authentication for every calibration adjustment.

  • Immutable Audit Trails: Blockchain-based logs to prevent tampering during audits.

  • Case Study: A vaccine producer passed FDA inspections with zero deviations using Part 11-compliant calibration software.