The entire product result (the implemented design, manufacturing processes, packaging, labels, accessories, shipping details, environment and regulatory agency requirements and compliance certificates, Declaration Of Conformance, etc.) is validated at the highest level to all of the feature, performance and conformance claims written in the MRD. This Product Validation Test (some call Production Validation Test) Validates that the 'correct product was designed'. This is the ultimate reality check for a product's correctness. The only changes allowed are those absolutely required, approved and funded, to make the validation successful.

When the Product Master Record is officially transferred to the manufacturer the product is ready for full production ramp-up, distribution, sales and support.

• Provide technical support as required for implementation and verification of: production processes, QC tests, assembly tests, Supply Chain Management, service tests and processes
• Validate the product to the MRD
• Validate the production process, including custom and COTS production equipment (MDOC, EXR, MTR²)
• Perform clinical trials or beta tests (MDOC, MTR²)
• Perform final regulatory compliance and environmental tests - usually required on products from the 'production line': compliance certificates and inspection reports (MTR²)
• Begin pre-production support.
• Pre-transfer manufacturing and service documentation to the manufacturer.
• Finalize all user, installation, programming manuals, etc.
• OEM qualification tests - usually required on a statistical sampling of products from the 'production line'.
• Perform an objective design review and fault analysis of production processes (MDOC)
• Continue full promotion of product
• Settle on shipping and distribution methods (MDOC)
• Verify trouble-shooting procedures for service and returned goods debug and testing.
• Develop production scale-up features and processes (MDOC)
• Transfer of complete, approved PMR (but not frozen) to the manufacturer.
• Provide appropriate training for the production group (MDOC)