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Validation Modernization: Adopting the CSA model using Agile

For, instance the validation engineer who currently writes most of the documentation will be tasked primarily with writing automated test scripts. The supplier auditor, along with the end-user, will be responsible for assessing what is useable from the supplier to reduce verification and validation testing.

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For, instance the validation engineer who currently writes most of the documentation will be tasked primarily with writing automated test scripts. The supplier auditor, along with the end-user, will be responsible for assessing what is useable from the supplier to reduce verification and validation testing.
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À propos de l'auteur

Kevin Bogert
Kevin Bogert is currently Managing Member of Azimuth Compliance Consulting, LLC and Managing Partner of Fortekna, LLC. He has more than 35 years of business experience, 29 of them in the life science industry, where he has been involved in global implementations of quality and regulatory systems. His background includes statistics, quality and regulatory systems, computer and process validation, and automation of manufacturing processes.

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