Computerized Systems Section
A Computerized Systems section documents how systems that create, modify, maintain, archive, retrieve, or transmit trial information are selected and controlled. Its focus is the system environment and its safeguards, not the scientific analysis performed with the data.
A Computerized Systems section explains which trial systems are used and the controls that keep them fit for purpose, secure, traceable, available, and appropriate to the risk of the activities they support.
Key details
Important caveats
Scope Boundary
Do not present one validation framework as universal. Requirements vary by system use, data criticality, sponsor procedures, jurisdiction, and applicable regulation.
Further guidance
Content
Describe relevant systems and intended uses, access/security controls, validation or fitness evidence, change management, backup/recovery or continuity arrangements, and responsibilities proportionate to risk.
Purpose
Show how technology-dependent trial activities are controlled without turning the section into a vendor inventory or generic IT policy.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E6(R3) Good Clinical Practice Guidance for Industry — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current ICH E6(R3) GCP guidance on investigator oversight, training/delegation, participant withdrawal, investigational-product accountability, site close-out, essential records, and insurance/indemnification
- E6(R3) Good Clinical Practice (GCP) — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current FDA final-guidance overview for ICH E6(R3), including quality by design, risk-based quality management, technology, proportionality, and clarified sponsor/investigator responsibilities