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From Computer System Validation (CSV) to Computer System Assurance (CSA) : How the Approach Is Changing and What QA Auditors Must Look For During Software Validation Audits

Moving from Computer System Validation (CSV) to Computer Software Assurance (CSA) is more than a terminology shift it’s a major change in approach, especially for QA auditors assessing software validation The focus is moving from protocol execution to providing substantial evidence that the system functions as intended, shifting the question from “Did we follow the […]

From Computer System Validation (CSV) to Computer System Assurance (CSA) : How the Approach Is Changing and What QA Auditors Must Look For During Software Validation Audits Read More »

Beyond Algorithms: Preserving ethical and human centric decision making in AI-Driven Drug Development

CDER and CBER have partnered with the European Medicines Agency (EMA) to establish 10 guiding principles aimed at assisting industry and product developers in utilizing artificial intelligence (AI) to enhance drug and biological product development. Most of the other nine principles formalize practices that pharmaceuticals and Biologics industry already understands well such as validation, traceability,

Beyond Algorithms: Preserving ethical and human centric decision making in AI-Driven Drug Development Read More »

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