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REGULATORY: Validation
QUALITY_SYSTEM
STANDARDS
DESIGN_CONTROL
RISK_MANAGEMENT
SYSTEM_MODELING
REQUIREMENTS
DESIGN_DESCRIPTION
UNIT_TESTS
VERIFICATION
VALIDATION
TRACEABILITY
AUTOMATED_V&V
  • 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.
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Contact: Henry Bryson, VP hbryson@syprosoft.com (949) 250-1065 x121
Syprosoft Inc. 9 Corporate Park, Suite 130 Irvine, CA 92606, USA (949) 250-1065 www.syprosoft.com
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