ARTICLES BY ALLAN MARINELLI
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Agile Software Development In Bio/Pharma & Medical Devices, Part 37/25/2023
Computer software/systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared Agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration and change management, CAPA, and more.
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Best Practices In Environmental Monitoring Sampling — Transportation & Analysis5/23/2018
The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases. This article discusses the final two phases.
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