- 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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