Change Control & Impact Assessment – QMS Template Pack

This template pack provides a structured framework for managing change control within a GMP‑regulated quality system, including assessment of quality, compliance, and computerized system impacts.

The pack supports controlled initiation, evaluation, approval, implementation, and closure of changes affecting processes, procedures, facilities, equipment, and computerized systems.

Templates are designed to facilitate consistent impact and risk assessment, including consideration of validation requirements, data integrity, and regulatory expectations.

Documents are intended to be used together as an integrated change management system, while remaining suitable for individual use by experienced quality, engineering, and validation personnel. All templates are generic and may be adapted to suit organisational complexity and regulatory scope.