Traceability and Record Management (GPSR) SOP

This detailed SOP provides compliance officers, quality assurance professionals, and production managers with a structured framework for managing Traceability and Record Management (GPSR).
Key features include:
– Subprocesses and Process Flow: Outlines four critical subprocesses—Record Creation and Maintenance, Batch Tracking, Compliance and Auditing, and Continuous Improvement. Each subprocess includes detailed actions, decision points, and templates to ensure operational efficiency and regulatory compliance.
– Risk Management: Identifies potential risks, such as data inaccuracies, traceability chain breaks, and data breaches, with mitigation strategies that include automated verification tools, immediate investigations, and secure encryption with daily backups to ensure data integrity.
– Compliance and Regulatory Requirements: Ensures adherence to GPSR and data retention standards, including secure data storage for at least 10 years and rapid corrective actions within 24 hours for non-compliance or traceability disruptions.
– Key Performance Indicators (KPIs) and Controls: Defines essential KPIs, such as data accuracy rate, traceability restoration time, and compliance audit scores, supported by controls like regular compliance reviews, automated notifications, and secure data management systems.
– RACI Framework: Clearly delineates responsibilities for roles such as Data Managers, Compliance Officers, IT Specialists, and Quality Analysts, ensuring transparency and collaboration throughout the record management process.
– Systems Requirements: Specifies necessary tools, including Record Management Systems, Batch Tracking Systems, and Compliance Management Platforms, to facilitate seamless record creation, traceability, and compliance monitoring.
– Appendices: Provides practical resources such as checklists, email templates, and real-life scenarios to guide users in implementing best practices for traceability and record management effectively.