Independent Validation & Verification

Realtime Systems treats Independent Verification and Validation (sometimes known as Design Assurance) as a separate project, driven by its own set of goals that are distinct from development team efforts. However, like a development activity, the V&V of a product must be planned and executed efficiently. To be most effective, the V&V team members should have intimate, unbiased participation in requirements definition, design reviews, code inspections, and configuration change board decisions.

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Verification and Validation Planning:

• V&V Plan and Effort Estimations
• Regulatory Compliance Strategies
• Development of Test Objectives
• Use of Simulation Environments
• Software Maintenance and Upgrades

Design Assurance Activities:

• Standard Operating Procedures
• Team Training
• Design Reviews
• Metrics and Static Analysis Reports

Software Quality Assurance:

• Dedicated specialists in Software Quality Assurance
• ISO 13485 Process Validation and ISO 14971 Risk Assessments
• SEI Capability Maturity Model Processes
• QSR and 21 CFR Part 11 (Electronic Records) for FDA
• DO-178B for Avionics
• Design Reviews, Code Inspections, and Internal Audits
• Metrics and Static Analysis Reports

Test Execution and Reports:

• Test Case and Protocols Development
• Test Execution and Report Generation
• Problem Tracking and Change Requests