Computerized System Validations(CSV)

The purpose of Computerized System Validations (CSV) is to establish and document the requirements necessary to ensure that all components, control systems, and functionalities of computerized systems are suitable for Good Manufacturing Practice (GMP)-regulated processes.

CSV is conducted in compliance with FDA 21 CFR Part 11, EU Annex 11, and other applicable industry regulations, guidelines, and best practices to maintain data integrity, reliability, and security throughout the system's lifecycle.

The Lifecycle of Computerized System Validations

Validation is not a one-time activity but a continuous process throughout the entire lifecycle of a computerized system. The key phases include:

• Planning & Requirement Definition – Identifying system objectives, user needs, and regulatory requirements.
• System Specification & Design – Defining the system architecture, functionalities, and compliance measures.
• Testing & Qualification – Ensuring proper functionality through IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Operation & Continuous Monitoring – Managing system performance, security, and compliance throughout its use.
• Change Management & Periodic Review – Addressing updates, modifications, and revalidations.
• Decommissioning & Data Migration – Retiring systems while ensuring critical data is securely archived or transferred.