REGULATORY SERVICES: Validation
- Verification confirms that the “product was built right”, while validation confirms that the “right product was built”. Verification activities form an important component of the validation process. Syprosoft Engineering has helped its clients develop validation protocols and validation reports for various medical devices. For products containing software, we have developed Software Validation Protocols (SVaP) and Software Validation Reports (SVaR).
- Syprosoft Engineering has helped its clients execute dry runs of test protocols. One purpose of the dry run is to “debug” and finalize the protocol. The other purpose of the dry run is to find as many issues as possible and help mature the product. The dry run may be performed with a prototype version of the product. The final run is executed on the release version of the product. Tools may be used to manage the runs. A screenshot of such a tool is shown below.