Posted by 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
- ISPE GAMP5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. International Society for Pharmaceutical Engineering (ISPE) (April 2008).
- ICH Harmonised Tripartite Guideline – Quality Risk Management – Q9 (November 2005)
- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme PIC/S Guidance: PI 011-3 Good Practices for Computerized Systems in Regulated “GxP” Environments (25 September 2007).
- Guidance for Industry – Part 11, Electronic Records; Electronic Signatures – Scope and Application (August 2003 Pharmaceutical CGMPs)
- Quality Assurance Journal – Effective and Practical Risk Management Options for Computerized System Validation – A Manuscript Accepted for Publication in Volume 9 Issue 3 (2005)
- http://www.pharmacompliancemonitor.com
- https://www.gxp-cc.com/it-embedded-systems.html
- https://www.fda.gov/downloads/medicaldevices
- https://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm
- https://www.fda.gov/iceci/inspections/inspectionguides/ucm074869.htm
About the Author:
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