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Sample PTC Integrity Reporting

Written by SPK Blog Post
Published on January 22, 2018

Download the Requirements Traceability Report 
This report starts with a Market Requirements document, and traces down to the Tests and Test Results.
Sheet 1 covers compact categorization, where the artifacts are basically defined by the Document types.
Sheet 2 includes data categorized by both Document type (Item type) and Category value.
Sheet 3 categorizes data by Document type, Category value for the content, and containing Document instance (Document ID).
Download the Requirements Traceability Report here.

Download the Medical Device Design Input Output Verification Validation Report
Sheet 1 traces from Market Requirements through System Requirements to Validation Tests (and associated results).
Sheet 2 traces from System Requirements through System Architecture design specifications, to Verification Tests (and associated results).
Download the Medical Device Design Input Output Verification Validation Report here.

Download the Validation Test Summary Report
This report starts with a Validation Test Protocol document, and traces to the System Requirements that the tests validate as well as the test results for those tests.
The summary data is obtained from the Test Objective that is related to the Validation Test Protocol document, demonstrating the flexibility that version 2.7 of the SPK Trace Report Engine has around sourcing the summary page data for the report.
Download the Validation Test Summary Report here.

 

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