FREQUENTLY Asked Questions
What does verification and validation of software devices consist of?
View All FAQs
About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Verification means "confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” In a software development environment, software verification is confirmation that the output of a particular phase of development meets all of the input requirements for that phase. Software testing is one of several verification activities intended to confirm that the software development output meets its input requirements. Other verification activities include:

  • walk-throughs
  • various static and dynamic analyses
  • code and document inspections module level testing
  • integration testing

Design validation means "establishing by objective evidence that device specifications conform with user needs and intended use(s).” One component of design validation is software validation. Software validation refers to establishing, by objective evidence, that the software conforms with the user needs and intended uses of the device. Software validation is a part of design validation of the finished device. It involves checking for proper operation of the software in its actual or simulated use environment, including integration into the final device where appropriate. Software validation is highly dependent upon comprehensive software testing and other verification tasks previously completed at each stage of the software development life cycle.

Planning, verification, traceability, configuration management, and many other aspects of good software engineering are important activities that together help to support a conclusion that software is validated.

Related Terms:
No items found.
Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST