A Practical Risk-Based Approach to Computerized System Validation

Overview

Computerized System Validation (CSV) is a process of achieving and maintaining compliance with applicable GxP regulations and fitness for intended use by the adaptation of principles, approaches and life cycle activities within the framework of validation plans and reports & by the application of appropriate operation controls throughout the lifecycle of the system.
Pharmaceutical and Life Sciences industries witness constantly evolving stringent regulations & requirements of CSV by major regulatory authorities such as USFDA, EU, Japan Regulatory Authority & others. Hence, validation services have become an integral part of the business requirements across these industries.
This whitepaper provides an overview of the CSV expectations of the industry to overcome the challenges associated with Software Validation & its Compliance. It provides a road map of best practices for practical risk management methods during the CSV process which is gaining wider acceptance across the globe.

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References

About the Author:

Lavanya G

Lavanya G, Associate Manager – CSV at iMEDGlobal Solutions India Pvt. Ltd. an FMD K&L Company. With a professional career of 13+ years, she is providing CSV services to Life Science & Pharma Industries with domain knowledge of Validation & Compliance. She is proficient in CSV process, Risk & Issue Management, Implementation of QMS methodologies & maintaining the Quality related attributes in-line with GxP guidelines and regulations

DISCLAIMER: The information provided in this White Paper is strictly the perspectives and opinions of individual authors and does not represent the opinions and statements of the iMEDGlobal (an FMD K&L Company).