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Computer Software Assurance (CSA) : Critical Thinking and Risk Based Approach

Computer Software Assurance (CSA) : Critical Thinking and Risk Based Approach

The Purpose of this Blog is to Provide guidance for the industry on the key concepts of Computer Software Assurance and provide direction to apply rational and critical thinking and commensurate it with risk associated with product quality and patient safety. This document takes into consideration challenges with the current computerized system validation approach and …

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Pharmacovigilance

Pharmacovigilance

Knowing What Pharmacovigilance is? According to WHO Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. But to make it simple, etymologically Pharmacovigilance is to keep a watch on drugs (Pharmakon= Drug, Vigilare= to keep a watch).         …

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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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Herbal Drug Regulatory Affairs

Herbal Drug Regulatory Affairs

Herbal medicines, known as phytomedicines or botanical medicines (Phyto- Plant) contains plant parts like, leaves, roots, stem, flowers, and seeds for therapeutic purpose. It is the oldest and still most generally used system of medicine in the world at present. 80% of the world population relies on herbal medicines as their primary healthcare system. Get …

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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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