Standards validation is the process of confirming that a development product satisfies its intended use and stakeholder requirements—distinct from verification, which checks only internal specification conformance. It employs testing, formal review, and compliance checks against published standards such as IEEE 1012 and FDA Computer Software Assurance to ensure the correct artefact was built.
Semantic Classification
Content
Overview
- Standards validation confirms that products fulfill their intended use and goals, distinct from verification which confirms products meet developer plans. The process ensures models accurately represent real-world applications and quantifies how parameter variations affect outcomes.
Technical Details
Key Standards
- IEEE 1012-2024: Covers Verification and Validation (V&V) processes for systems, software, and hardware including interfaces
- ASME VVUQ Standards (2024): Including multivariate metrics, scaling methodologies for nuclear systems, and computational physics simulation software selection
- FDA Computer Software Assurance: Risk-based approach for medical device software validation
Validation vs Verification
- Verification: Confirms “you built it right” - product meets developer plans
- Validation: Confirms “you built the right thing” - product meets stakeholder goals
Applications
- Medical device software development and FDA compliance
- Computational modeling in engineering and science
- Clinical database and data capture system testing
- Cloud-based validation platforms for distributed teams
- Automated validation using digital technologies (66% of organizations expect increased adoption)