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.