What is Computer System Validation?

Computer system validation (CSV) is the documented process of verifying that a system meets its design requirements and adheres to predefined specifications. It aims to ensure that the output of a system consistently conforms to its intended uses throughout its lifecycle.

Importance of CSV

As more critical processes in industries like healthcare, manufacturing and financial services become dependent on computer systems, validation assumes greater importance. Any failure or error in a system used for product quality checks, medical devices or banking transactions could have far-reaching consequences. Computer System Validation establishes quality checks at each stage - from design and development to implementation and use - to minimize risks.

Regulatory Requirements

Most regulated industries have explicit validation requirements. The FDA's 21 CFR Part 11 mandates validation for any system handling electronic records in the pharmaceutical sector. Similarly, ISO13485 details validation criteria for medical devices. The main goal is to certify that systems are built as per specifications and function reliably. Validated systems allow companies to demonstrate regulatory compliance during audits.

Planning and Documentation

A validation plan is developed before the actual validation process begins. This forms the roadmap, outlining activities, responsibilities, acceptance criteria and timelines. Comprehensive documentation tracks adherence to protocols and generates objective evidence. Change management procedures detail the protocol for modifying validated systems. Clear SOPs guide revalidation in case of changes impacting system performance.

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