Скачать или смотреть Going Beyond CSV to Self Validating Software

Computer software validation (CSV) is a common challenge in life sciences companies. That’s primarily because these organizations err on the side of caution and do more work than is required by the regulations. A risk-based approach cuts days out of the validation process. The future of validation is even faster, with most of the work being done by the software provider.

In this presentation, Director, Product Management Erin Wright explains the changes coming to validation, including the anticipated computer software assurance (CSA) guidance from the U.S. Food and Drug Administration (FDA). She then explains how self-validating software is possible when software companies are willing to put in the work and build validation into their products.

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MasterControl Inc. is a leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. Over 1,000 companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. For more information, visit https://www.mastercontrol.com/
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