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Product Life Cycle: Verification/Validation

Requirements > Design > Development > Verification/Validation > Certification > Automated Test

Verification/Validation

The process of verification and validation (V&V) is a critical part in development of safety or mission critical software, hardware or test systems. It is particularly important in regulated industries, such as medical devices, pharmaceutical, aerospace or military applications, which are subsequently certified to system requirements prior to approval by regulatory agencies and certification authorities.

In general terms, verification determines if the design output matches the inputs, usually concurrently with development. Validation ensures that user needs are met in the finished product.

RTCA DO-178B defines verification as “the evaluation of the results of a process to ensure correctness and consistency with respect to the inputs and standards provided to that process”. Validation is defined in DO-178B as “the process of determining if the requirements are the correct requirements and that they are complete”.

CertTech has a proven track record of helping customers throughout the V&V process in the military/aerospace, rail transportation and medical device industries, providing support with:

• Automated software testing
• Software tool development & qualification

Automated Software Testing

RTCA DO-178B describes two objectives of software testing:

• Demonstrate that the software satisfies its requirements
• Demonstrate that errors that could lead to unacceptable failure conditions have been removed

Two key test efforts under DO-178B are:

• Requirements based testing (RBT)
• Structural coverage analysis

CertTech provides support throughout the automated software testing process, including:

• Development of the test environment
  • On-target
  • Off-target, using simulation
• Test case development
• RBT testing process
  • System testing
  • Integration testing
  • Unit testing
• Requirements coverage analysis
• Structural coverage analysis

Software Tool Development & Qualification

Software tools are used extensively in aviation software development. Nearly every aviation software project use one or more tools, many of which require qualification. Example of tool uses include requirements-based testing or structural coverage analysis. There is also an increasing amount of tool usage in FDA regulated environments, and medical device manufacturers and FDA are using static analysis tools for medical device software.

CertTech has extensive experience in the development and utilization of software tools, primarily in the areas of:

• Testing tools: Requirements-based test execution and reporting
• Analysis tools: Structural coverage analysis, static/dynamic analysis
• Requirements analysis and management

CertTech has demonstrated the ability to develop or adapt tools, if there are no commercially available tools to meet customer needs. For example, CertTech has developed a National Instruments™ LabWindows/CVI™ -based tool that has been qualified to DO-178B on a project-specific basis.

CertTech also has experience in qualification of software tools. Under RTCA DO-178B, Section 12.2, tool qualification is a process “to ensure that the tool provides confidence at least equivalent to that of the process(es) eliminated, reduced or automated”. Similarly, the FDA Software Guidance, Section 5.2.5 specifies that “documentation demonstrating validation of these software tools for their intended use should be maintained”.

Additionally, CertTech provides a DO-178B qualification kit for BullseyeCoverage, which is a code coverage analyzer for C++ and C. This kit includes the templates listed below. Follow this link to a press release which provides additional background on the partnership with Bullseye Testing Technology; please contact us for more information, including pricing and availability.

• Generic Tool Operational Requirements (TOR) for Bullseye Coverage for ANSI-C
• Generic Tool Qualification Plan (TQP)
• Requirements-based Verification Procedures
• Generic Tool Qualification Accomplishment Summary (TQAS) document