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This procedure covers the requirements specific to software tool validations including software used in quality management systems, production and service provision, and for the monitoring and measurement of requirements. This procedure does not apply to software used as a component, part, or accessory of a medical device or software itself that is a medical device – those software validation activities are covered in SYS-044. This procedure is not applicable to processes that do not affect the products intended for commercial distribution.

About the course

Includes: - SYS-051, Post-Market Surveillance Procedure - TMP-016, Software Tool Validation Plan Template - TMP-015, Software Tool Requirements Template - TMP-039, Software Traceability Matrix - TMP-025, Software Verification Protocol Template - TMP-026, Software Verification Report Template

Curriculum

1 Chapter · 7 Lessons

1. (Included in full purchase)
  SYS-051: Software Tool Validation Procedure
2. (Included in full purchase)
  TMP-016, Software Tool Validation Plan Template
3. (Included in full purchase)
  TMP-015, Software Tool Requirements Template
4. (Included in full purchase)
  TMP-039, Software Traceability Matrix
5. (Included in full purchase)
  TMP-025, Software Verification Protocol Template
6. (Included in full purchase)
  TMP-026, Software Verification Report Template
7. (Included in full purchase)
  LST-006: Equipment Register

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