Testing product verification phase

Each requirement for a medical device has to be written in such a way that it is testable. At the end of the development cycle, verification and validation of the product has to be performed. This is meant to guarantee that the product developed is the product desired by the user. The verification step is simplified if the requirement specification is written in a form that every requirement is testable. Therefore, the test department is included in the process of writing the requirements. In generating a model and in writing the requirements in a testable way, the test department can plan and develop tests for the system verification phase. Having the tests be developed in parallel to the system itself saves valuable time and leads to shorter time to market. The verification phase is usually followed by a validation phase. This validation phase is somewhat comparable to a beta test phase common with software products. The devices are given to a defined number of users for validation. Of course, this phase should not lead to requirement changes. 

Design Qualification (DQ) is the first validation element of a new facility system or equipment, where adherence to the user s specifications and to GMP rules is demonstrated. Installation Qualification (IQ) follows with the verification of adequacy of the area, installation of equipment pipelines, utilities, instrumentation, and conformity of the material used to the project specifications. At the Operational Qualification (OQ) phase, carried out after installation of all equipment, it is verified whether the system, when in operation, complies with the acceptance criteria defined in the validation plan. Once the OQ phase is successfully finalized it is possible to proceed with the calibration procedures, operation and cleaning, operator training, and preventive maintenance program. After IQ and OQ are concluded, it is time for the Performance Qualification (PQ), with the aim of verifying that what was designed, built, and operated results in a product that meets the expected specifications. Production and QC personnel are specially trained for these assessments. The tests can be done with the product of interest or a placebo, and are related to all operations, from raw material reception to product release (EC, 2001). 

Special verification, by appropriate tests, of the critical operations phases likely to have repercussions, even distant, on the quality of the finished product. 

During design verification, the detailed design is verified, tested, and refined (if necessary). This phase starts after the detailed design is completed and the complete documentation, including technical drawing, machine control files, and productimi plans, for the product is finished (Pahl and Beitz 1996). 

SIS verification Testing and evaluation of output at a given phase with respect to products and standards for the given input. 7,12.7... 

The third phase focuses on the development of the first prototypes, the verification (often prototype tests) and the product and production process validation. At this point, the product design should be almost finalized. 

Verification is an activity of confirmation by objective analysis and test that the output of each phase of the life cycle fulfils the requirements of the previous phase (are we building the product right ). This entails for each development phase assessing conqrliance of a (sub-)system with its requirements by test, analysis or in-spectioa... 

The final phase of the creative process may involve experimentation to test promising solutions. It involves the evaluation and verification of the creative idea or product. 

SIS verification To test and evaluate the outputs of a given phase to ensure oorrectness and consistency with respect to the products and standards provided as input to that phase 7, 12.7 Plan for the verification of the SIS for each phase Results of the verification of the SIS for each phase Operations... 

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