A Strategic SOP for Secure Batch Record Retention & Regulatory Mastery
1. Purpose To establish a robust, compliant, and audit-ready system for the retention, protection, retrieval, and archival of Batch Records (BMR/BPR, electronic and manual), ensuring full alignment with current regulatory requirements, data integrity principles (ALCOA+), and Good Manufacturing Practices (GMP). This SOP ensures that all batch documentation is: 2. Scope This SOP applies to: It […]
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