Computer system validation (CSV) as per FDA

What is Computer system validation? Food and Drug Administration (FDA) guidelines for software validation outlines general validation principles applicable to medical device software or software used to design, develop, or …

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What is validation in pharmaceutical industry?

Validation is the most important activity in the pharmaceutical industry. There are multiple types of validation in the pharmaceutical, such as Analytical Method Validation, Process Validation, Cleaning Validation, Equipment Validation, …

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What are GAMP 5 Software Categories?

What are GAMP 5 software categories? There are 5 software categories as per the International Society for Pharmaceutical Engineering (ISPE).  In GAMP 4 there were 5 software categories but in …

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10 Method Validation Parameters in Pharma

Method Validation Parameters in Pharma Analytical Method validation is an essential step in the development of reference methods and in the assessment of a lab’s ability to produce reliable analytical …

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