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Introduction Computer System Validation consists of the activity necessary to confirm that computer systems perform their intended functions reliably, accurately, and consistently in a regulated environment. The testing and documentation of software and hardware systems are included in this, ensuring they meet predefined specifications and regulatory requirements. CSV is not only meant to confirm system […]

Introduction Regulatory affairs in India are core in the pharmaceutical and healthcare industries, positioning products to meet the high standards both nationally and globally. The apex regulatory organization is the Central Drugs Standard Control Organization, which monitors the approval, quality assurance, and regulatory compliance of drugs and medical devices. Regulatory affairs have gained prominence with

Introduction Change control is one of the most important elements of CSV, which provides assurance that changes to validated systems are examined systematically, documented, and implemented without compromising the system’s integrity, compliance status, or intended function. In regulated industries like pharmaceuticals, biotechnology, and medical devices, where computerized systems manage data impacting product quality and patient

Introduction The pharmaceutical industry faces serious pressure regarding enhancing operational effectiveness while strictly observing regulatory standards in continuous development. For many organizations, balancing these imperatives within an environment that is highly competitive and driven by innovation is a challenge. Consequently, more pharmaceutical companies have begun taking advantage of advanced digital solutions to streamline operations, maintain

Data integrity is everything in today’s modern world. Whether it deals with financial reports, sales forecasts, or inventory tracking, several business outcomes are hinged on data accuracy. Excel sheets, being versatile, are used across industries to handle data. However, human error and incorrect formulas and inconsistency in data entry can jeopardize the accuracy of the