Traceability and Record Management (GPSR) Process Playbook

This detailed playbook provides compliance officers, quality assurance teams, production managers, and logistics personnel with a structured framework for managing traceability and record management under the EU General Product Safety Regulation (GPSR).
It includes:
– Step-by-Step Process Flow: Outlines essential subprocesses such as Record Creation and Maintenance, Batch Tracking, Compliance and Auditing, and Continuous Improvement. Each step provides clear actions, decision points, and mechanisms for ensuring accurate records, effective batch tracking, and compliance with regulatory standards.
– RACI Framework: Clearly defines roles and responsibilities for each task in the traceability and record management process. It ensures that Data Managers, Compliance Officers, IT Specialists, and Quality Analysts are accountable and engaged at every stage, promoting transparency, collaboration, and efficiency in managing records and traceability.