Verification, Validation & Statistical Sampling
Verification, Validation & Statistical Sampling
Generating Reliable Evidence Through Risk-Based Testing and Validation Strategies
Verification and validation activities must provide traceable evidence that defined requirements have been met and that products or processes are suitable for their intended purpose.
Appropriate statistical planning can help justify testing effort, evaluate uncertainty, and support reliable conclusions from test results.
Avary Consulting supports companies in developing and evaluating verification and validation strategies, statistical testing concepts, and risk-based sampling plans.
We consider applicable requirements under ISO 13485, ISO 14971, the MDR, IVDR, FDA regulations, and, where relevant, pharmaceutical process validation requirements.
Our services include:
- Development of risk-based verification and validation strategies
- Statistical planning of product and process testing
- Selection of appropriate sampling methods
- Justification of sample sizes based on defined statistical assumptions
- Application of suitable confidence and reliability concepts
- Evaluation of measurement systems and process capability
- Statistical analysis of validation data
- Support for documentation and interpretation of results
Depending on the testing objective, recognized statistical principles such as those described in the ISO 2859 series for acceptance sampling by attributes may be considered. The selection of a sampling methodology always takes into account product risk, testing objectives, and the applicable regulatory context.
Your Business Value: Scientifically justified testing strategies, efficient resource utilization, and transparent, defensible quality evidence.