Test method validation engineers assist medical device, biotech, and pharmaceutical companies with risk mitigation by assessing the suitability of methods used to accept or reject products. Test methods fall into attribute (visual) and variable (dimensional) categories.

Test method validation is a pre-requisite to process validation and serves as objective evidence that a measurement/inspection system is capable of producing repeatable and reproducible results. Typically, the industry standard for acceptance of a method is less than 30 percent Tolerance for variable and a zero misclassification rate for beta error (non-conforming samples identified as conforming) in attribute inspections.  

Situations often arise that require investigations to determine the root causes of failures and subsequent improvements to equipment and instructions to reduce or eliminate sources of measurement variation. This requires test method validation engineers to be very methodical in their approach, which is why it is a discipline that is best learned through experience. 

Hiring the right Test method validation engineers can significantly increase quality, reduce risk, and offset the costs of purchasing expensive test equipment.

Companies often hire test method validation engineers to alleviate the demand that validation activities create on their full time engineering staff. This allows company resources to focus on research and development as well as day-to-day manufacturing operations needed to remain competitive in today’s healthcare marketplace.

Validation Consulting Inc. offers turnkey validation consulting services as well as engineering staffing solutions for domestic and international projects.

Validation Consulting Inc. assists clients with   Test Method Validations, Destructive Testing, Non-Destructive Testing, Attribute Inspections, Test Method Development and Operator Certifications.

Our consultants specialize in the following core competencies of test method validation;

Validation is our niche. Our solutions are comprehensive and encompass the full spectrum of quality, compliance, and validation services. Unlike any other service provider, our core team consists of engineers who work in industry and specialize in identifying and placing the right people for your project.

Our test method validation engineers and subject matter experts support short and long-term project assignments. We have a proven track record of providing validation services and measure our success through complete customer satisfaction. Contact us and see what makes us different!