Process Owner (Business Owner)
Accountable for the business process the system supports. Approves requirements, ensures user training, and validates that the system meets intended use.
CSV for GxP
Roles and Responsibilities in Computer System Validation
CSV is a cross-functional effort. Clear ownership ensures requirements, testing, and approvals are aligned and audit-ready.
System Owner (IT Owner)
Maintains system availability and configuration. Responsible for change control, system inventory, and keeping the system in a validated state.
Validation Lead / SME
Guides validation strategy, coordinates documentation, and ensures testing aligns with regulatory expectations and risk assessments.
Quality Assurance (QA)
Provides independent oversight, reviews protocols and reports, and confirms deviations are resolved. QA approvals are required for release decisions.
IT / Developers
Configure or build the system, support installations, and resolve technical issues during OQ/PQ testing. Provide technical documentation and evidence.
End Users / Operators
Define practical requirements and execute user acceptance scenarios. Their feedback confirms that workflows are fit for real operations.
Suppliers / Vendors
Provide system documentation, release notes, and support evidence such as testing summaries or configuration guides. Supplier quality agreements clarify responsibilities.
Validation Team / Committee
For large programs, a cross-functional steering team aligns priorities, resolves scope changes, and ensures timely approvals.
See roles in action
Our case study shows how these roles collaborate during a real-world validation project.