Direct Impact System
Any equipment or system that is part of a validated manufacturing process or produce data used to make decision related to product quality will normally be a direct impact system.
or
Any equipment or system whose failure could directly affect the product quality.
Some Examples:
- Process Equipment and Systems
- Laboratory Instruments and Systems
- Utilities
- Computerized Systems
All computerized systems which influence the product quality and applications which will support analytical procedures and the batch release shall be categorized according to the GAMP 5 approaches.
For further reading please refer: ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems.