This section defines the end-to-end validation lifecycle from intended use and planning through requirements, configuration, risk assessment, verification, migration, release, change control, periodic review, and retirement. It emphasizes requirements-based and risk-based assurance, appropriate use of supplier evidence, traceability, representative end-to-end testing, controlled release, and documented maintenance of the validated state.
Computerized system validation (CSV) planning defines how an organization will establish and maintain confidence that a system is fit for its intended GxP use. The validation plan should convert the system’s intended use, risks, architecture, software type, supplier capabilities, and…
A User Requirements Specification (URS) defines what a computerized system must do to support its intended business and GxP use. Intended use, system boundaries, and GxP relevance should first be established through Computerized System Types, Intended Use, and GxP Classification….
Computerized system specifications translate approved user requirements into the functions, design, configuration, interfaces, calculations, reports, and technical components that will be built and verified. The User Requirements Specification for Computerized Systems defines what the regulated business needs. Specifications explain how…
Computerized-system risk assessment determines what could fail, why the failure matters, which controls are needed, and what evidence is required before the system is released. It should connect the system’s intended use and requirements with credible failure scenarios affecting patient…
Requirements traceability demonstrates how a computerized system’s intended use is translated into requirements, controls, specifications, configuration, verification, operational procedures, and release evidence. A traditional requirements traceability matrix may connect each user requirement to one or more tests. That connection is…
Computerized system Installation Qualification (IQ) provides documented evidence that the approved application, technical components, and supporting environment have been installed or provisioned correctly. IQ should establish what is installed, where it operates, how it is identified, which services it depends…
Computerized system functional and control testing provides documented evidence that the configured system performs its approved functions and that its preventive, detective, and corrective controls operate effectively. This activity has traditionally been called Operational Qualification (OQ). The term remains useful…
End-to-end and user acceptance testing confirms that the complete configured computerized system supports its approved intended use within the actual business process. This testing evaluates more than individual application functions. It brings together representative users, approved procedures, realistic data, connected…
Computerized system data migration validation provides documented evidence that regulated data and records are transferred completely, accurately, securely, and with their required meaning and context preserved. Migration may occur during: A technically successful transfer does not establish that the migrated…
Computerized-system release is the controlled decision that a system is suitable for its intended GxP use and may enter production operation. It is not simply the approval of the final test protocol or confirmation that software has been installed. The…
Computerized systems continue to change after release. Application upgrades, configuration changes, security patches, report revisions, interface modifications, master-data updates, and infrastructure replacements can alter validated functions or the electronic records they create and maintain. Change control provides a documented process…
Computerized systems should remain suitable for their approved GxP use throughout their operational life. Initial validation establishes that suitability before release; periodic review confirms that changes, incidents, security conditions, supplier developments, and operating experience have not undermined it. Periodic review…