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ASSESS
System Assessment
Four questions to shape the assessment. Unknowns stay open for review.
1
Assess
2
Plan
3
Review
1. System use
2. GxP relevance
3. Failure impact
4. Existing evidence
What does the system do?
System name
What does the system do, and who uses it?
Include the process, important functions and decisions or records that depend on it.
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Save working file
Open working file