FREQUENTLY ASKED QUESTIONS

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.

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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.