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The acronym CSV stands for Computer System Validation. In the context of the pharmaceutical industry, CSV in Pharma refers to the process of ensuring that computerized systems used in the development, manufacturing, and quality control of pharmaceutical products are properly validated. This process ensures that these systems operate as intended, maintaining the accuracy, reliability, and security of the data they manage, which is crucial for product quality and patient safety.

For companies like Knors Pharma, CSV in Pharma is essential for regulatory compliance, particularly with guidelines such as FDA 21 CFR Part 11 and EU GMP Annex 11, which mandate the validation of computerized systems used in pharmaceutical processes. By adhering to these standards, Knors Pharma ensures that its systems are secure, that data integrity is maintained, and that the company complies with global regulatory requirements, ultimately guaranteeing the safety and quality of its pharmaceutical products.

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Knors Phrma

Lvl 3
2mo ago

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