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Computer System Validation (CSV) In Pharmaceutical Industry

Computer System Validation (CSV) In Pharmaceutical Industry

Computerized system validation (CSV) (usually referred to as “Computer Systems Validation”) is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. This is widely used

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Medical Writing

Medical Writing

Become a certified Medical writer from best Institute in India Changing market dynamics, expiring patents, and depleted product pipelines are all exerting pressure on pharmaceutical companies to outsource non-core activities in an effort to control costs and enhance drug-development cycle time. One of these activities is medical writing—an area that, although not at the core

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Regulatory Medical Writing

Regulatory Medical Writing

Drug development is a billion-dollar industry featuring a variety of roles necessary to pursue the goal of product approval. A crucial component within this process is well-developed, well-documented, and well-communicated study research practices. Medical writers act as key communicators for study sponsors and governmental agencies, such as the U.S. Food and Drug Administration (FDA) and

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