Manufacturing Software Validation – Requirements Traceability Matrix

The Traceability Matrix defines the relationship between the Requirements / Specification Documents, Design Documentation and Test Scripts as defined in the Testing Protocols for the InstantGMP™ MD medical device manufacturing software.

The Traceability Matrix provides a method to trace and ensure that system validation addresses all requirements, specifications and functions addressed during the test phase of the validation effort. This document provides the evidence that all requirements and specifications have been satisfied through technical and procedural controls.

 

 

 

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