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What is computerized System Validation 

Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 CFR 11.10(a) and EMA Annex 11, Section 4.

Why Validation is Required 

Following is the reason to have Validation in Pharma Industries

- To Prevent Software/Process problem to reach to the production.

- To Avoid serious consequences.

- It is regulatory Requirement.

- It gives us assurance that developed product will function accurately and will produce results as intended.


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