Computer System Validation
Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems in order to ensure product safety and effectiveness . Computer system validation is required when configuring a new system or making a change in a validated system (upgrades, patches, extensions, etc.).
We partner with our clients, working with them to define the road to compliance within their environment. Our skilled team has the necessary training in FDA and other industry regulations and best practices. We follow internationally accepted GAMP 5 guidelines and its current interpretations for validation of computer systems applying Risk Based Approach and Life Cycle Management philosophy.
Our major services in Computer System validation are as under:
Laboratory Computerized System Validation
Process Control (PLC/ SCADA ) and Manufacturing System Validation
IT Infrastructure / Workstation/ Server Qualification
Data Centre Qualification
Network Qualification
ERP / SAP Systems Validation
Spread Sheet Validation
Our domain experts have extensive experience in completing system validation activities by using the GAMP5 risk-based validation framework. We have delivered many system implementation and upgrade projects across various pharma industry verticals to help clients to achieve 21 CFR Part 11 and EU Annex 11 regulatory compliance.
