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REGULATORY: Unit Tests
QUALITY_SYSTEM
STANDARDS
DESIGN_CONTROL
RISK_MANAGEMENT
SYSTEM_MODELING
REQUIREMENTS
DESIGN_DESCRIPTION
UNIT_TESTS
VERIFICATION
VALIDATION
TRACEABILITY
AUTOMATED_V&V
  • Syprosoft Engineering has helped its clients perform software unit level tests. This testing is guided by FDA requirements which state that system and integration testing is not enough … we need to do unit level testing. This involves identifying the low-level software requirements and performing comprehensive unit-level white-box testing based on these requirements.

  • Branch coverage is the minimum the FDA considers acceptable. This criterion requires sufficient test cases for each program decision or branch to be executed so that each possible outcome occurs at least once. The figure below is an example of unit testing being performed and the coverage achieved being tracked.

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Contact: Henry Bryson, VP hbryson@syprosoft.com (949) 250-1065 x121
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