Validation vs. Testing in a Regulated Environment

Andrew Oliver, Dendrite International, Inc.

When the FDA approved the use of electronic signatures for drug acceptance by medical professionals, the software systems that captured those signatures fell under FDA audit scrutiny. Validation testing (required by the FDA) and system testing are different, so how can you effectively use the results of one to support the other? Learn about the three phases of validation testing and how to create test scripts that will delight your customers and the auditors. Find out how Dendrite employs traceability matrices that reduce testing costs and helps you meet FDA requirements. If you're looking for new ways to improve testing, you can pick up some valuable test process tips by attending this advanced session.

  • Make your system test results meet the three phases of validations testing-IQ, OQ, and PQ
  • Write system test scripts that can be used as protocols by clients

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