Computerized System Validation
Service Overview
- Computerized system validation (CSV) (Computerised system validation in European countries, and usually referred to as “Computer Systems Validation”) is the process of testing/validating/qualifying a regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper-based records. This is widely used in the Pharmaceutical, Life Sciences and Biotech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting. The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules.
- We have good expertise in validation documentation and validation execution. We use a Risk based approach of GAMP 5 for validation.
- Computer system validation is a critical tool to assure quality of computer system performance. Importance of Computer system validation are many. It enhances the reliability of system, resulting in fewer errors and less risk to process and data integrity. It also reduces long term system and project cost by minimizing the cost of maintenance and rework.
Computer Systems Validation Guide is based on the following approaches
• Risk-based approach
• Approach based on the life cycle of the system
• Approach on “V”-model for development and system test
• Approach on GAMP category system
• Approach based on the life cycle of the system
• Approach on “V”-model for development and system test
• Approach on GAMP category system
Benefits of Validation
• Compliance with regulatory requirements / Regulatory mandates (FDA)
• Ensure the accuracy, reliability, quality and integrity of data
• Minimized risk of malfunction
• Promotes continual process improvement
• Ensure the accuracy, reliability, quality and integrity of data
• Minimized risk of malfunction
• Promotes continual process improvement
Validation Document Cover in as per Following
• GxP Assessment / GAP Assessment
• User Requirement Specification
• Functional Requirement Specification
• Functional Risk Assessment
• Design Specification
• Validation Plan
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Requirement Traceability Matrix
• Validation Summary Report
• Supply Assessment report
• Periodic Review Report
• User Requirement Specification
• Functional Requirement Specification
• Functional Risk Assessment
• Design Specification
• Validation Plan
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Requirement Traceability Matrix
• Validation Summary Report
• Supply Assessment report
• Periodic Review Report
