Compliance By Analysis

compliance by analysisWe can evaluate a product and the test reports of testing conducted on it and similar products, test plans and compliance documents and use this to produce a “Compliance by Analysis” report.

Typically an compliance by analysis study will be conducted on a specific product (complete) with a review of the design verification and validation package, any current test results (in-house or external), and Life Cycle Environmental Profile.  Any test plans prepared for qualification will be reviewed, and all of this will be incorporated into a third-party compliance by analysis review and report.  If specific areas cannot be justified, corrective solutions may be proposed on a separate memo from the report.

For each item on a Product Test Plan Matrix to be reported, we typically will provide the following:

A. For each Item, short version (summary, references and conclusion) of compliance by analysis report.

 Compliance by Analysis Report

  1. Requirement
  2. References
  3. Data
  4. Analysis
  5. Conclusion
  6. Safety
  7. Recommendation

Or

B. Recommendation and guidance for testing or inspection by third party (if compliance by analysis not logical).  Post testing we will incorporate the findings into a compliance report as listed in “A” above.

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