Test Method Development and Validation

The development of test methods and their subsequent validation is an important not only for process validation activities, but for design verification testing as well.

Test method development is particularly important for unique test methods or when standard test methods require special fixturing. Documented test method development records demonstrate that the methods have a sound engineering basis and that enough experimental evaluation was performed to have confidence that the actual validation will be successful.

Validation of test methods provides the formal evidence that a test method will sufficiently and reliably produce measurements or results to a specified degree of accuracy at a particular confidence level. Even simple caliper or micrometer measurements can require validation when compressible materials are being measured, as there will be additional variability due to the compressibility.

AlvaMed experienced engineers have developed many different test methods and validated them in world class manufacturing environments. Let us assist you in meeting your test method validation needs.

We invite you to review a case study that is representative of the work done by our consultants...

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