Ensuring Compliance and Quality through Computer System Validation (CSV) for LIMS Applications

Authors

Jagan Mohan Rao Doddapaneni

Abstract

Computer System Validation (CSV) is a critical process in ensuring that Laboratory Information Management Systems (LIMS) function as intended across all development and production environments while complying with regulatory requirements. CSV ensures that LIMS applications meet predefined quality standards, are reliable, and maintain data integrity throughout their lifecycle. From a Business Analyst perspective, CSV ensures that business needs and regulatory requirements are effectively translated into system functionalities. From a QA Lead perspective, CSV guarantees robust validation strategies, mitigating risks associated with data handling, system failures, and regulatory non-compliance.This paper provides a structured approach to CSV in LIMS applications, outlining the challenges, methodologies, and best practices for validation across different environments—Development, Testing, Staging, and Production. The paper also highlights the importance of documentation, automation, and risk-based validation strategies in streamlining CSV efforts while ensuring compliance with FDA 21 CFR Part 11, GMP, GLP, and ISO 17025 regulations.

Keywords

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Ensuring Compliance and Quality through Computer System Validation (CSV) for LIMS Applications. Jagan Mohan Rao Doddapaneni. 2024. IJIRCT, Volume 10, Issue 4. Pages 1-4. https://www.ijirct.org/viewPaper.php?paperId=2502004