This section defines the end-to-end validation process from planning through system release. It maintains traceability from requirements through testing and ensures that systems are verified against intended use.
1. Purpose and Scope Computerized System Release is the formal process of authorizing a validated computerized system for its intended GxP use after all planned validation activities have been successfully completed. The release process confirms that the system is fit…
1. Purpose and Scope Operational Qualification establishes documented evidence that a computerized system operates as intended across all defined functional and regulatory requirements. This phase verifies system behavior under controlled conditions and confirms that configured functionality, workflows, and controls perform…
1. Purpose and Scope Performance Qualification establishes documented evidence that a computerized system performs reliably under routine operating conditions and intended use. This phase confirms that the system supports actual business processes, real users, and expected data volumes without compromising…
1. Purpose and Scope Installation Qualification establishes documented evidence that a computerized system is installed correctly and in accordance with approved specifications, vendor recommendations, and infrastructure requirements. This phase confirms that the system environment is suitable to support reliable operation…
Validation planning establishes the structured approach used to ensure that a computerized system is implemented, verified, and controlled in a manner consistent with regulatory expectations and business requirements. It defines how validation activities will be executed, documented, and maintained to…
Functional and Configuration Specifications define how the computerized system will be implemented to meet the User Requirements Specification. These documents translate high-level requirements into structured, testable descriptions of system behavior and configuration. For computerized systems, especially configurable platforms, the distinction…
Requirements Traceability establishes and maintains the linkage between user requirements, system specifications, and verification activities. It ensures that all defined requirements are implemented and tested, and that no functionality is introduced without justification. For computerized systems, traceability is a central…
The User Requirements Specification defines what a computerized system must do to support intended business processes while maintaining compliance with regulatory expectations. It is the primary reference for all subsequent design, configuration, and verification activities. For computerized systems, the URS…