Quality Assurance and Testing in an FDA Regulated Environment

Eric Toburen, Genilogix

How can we reduce costs associated with FDA imposed computer systems validation (CSV) guidelines and improve test coverage at the same time? Experienced in the use of automated testing tools in FDA regulated environments, Eric Toburen shares the challenges of complying with FDA validation guidelines. For many companies, manual CSV is a like a heavy boat anchor that slows projects and increases costs while adding no value other than the perception that the practice avoids an auditor's attention. Find out how automated testing and test management practices can be used to shorten the CSV lifecycle and improve test coverage. After deployment use the automated tests for regression testing to enable the deployment of bug fixes and upgrades minimizing the need for re-evaluation.

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