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Quality Engineering
  • Verification Protocol generation
  • SOP generation
  • Code inspections
  • Audits
  • System Validation Protocol generation

SRI Product Development has a team of engineers with experience in verifying and performing validation for complex systems. SRI has also performed third party software verification. The SRI team has a well defined verification process that can be scaled to validate an FDA Class III Medical Device. SRI's verification and validation processes meet both J&J and Baxter standards. The verification and validation process includes:

  • Creating test objectives to define tests for every requirement.
  • Tracing of all requirements and test objectives to ensure full test coverage.
  • Creating test objectives to define tests for every risk defined in the System Risk Analysis.
  • Creating test cases with defined test steps to fully test each test objective.
  • Dry running all test cases to ensure a successful validation.

 

 

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