Computerised System Validation
Explore all topics, guides, and frameworks related to Computerised System Validation.
Articles in this section
7- User Requirements Specifications (URS) in Pharmacovigilance Explains how user requirements translate pharmacovigilance business and regulatory needs into verifiable system expectations, while distinguishing regulatory assurance requirements from organisation-specific URS formats and validation document models. Read Article →
- Functional Specifications and Design Specifications in Pharmacovigilance Functional and design specifications are useful ways to translate pharmacovigilance requirements into system behaviour and technical implementation, but those exact document titles are not universal EU pharmacovigilance requirements. This article explains how to use specification evidence proportionately while preserving traceability from intended use through configuration, testing and change control. Read Article →
- Validation Testing in Pharmacovigilance: IQ, OQ, PQ and User Acceptance Testing Explains how testing demonstrates that pharmacovigilance computerised systems are fit for intended use, how qualification and user-acceptance concepts relate to risk-based assurance, and how testing should remain proportionate to patient-safety, data-integrity and regulatory risk. Read Article →
- Traceability Matrix in Computerised System Validation Explains why traceability is used in validation of pharmacovigilance systems, how forward and backward traceability support completeness and change impact assessment, and how to design proportionate evidence around regulated intended use. Read Article →
- Computerised System Validation Plan A Computerised System Validation Plan is a governance document that explains how an organisation will establish and maintain confidence that a pharmacovigilance computerised system is fit for its intended use. This article distinguishes the plan from legally binding requirements, shows how to define scope, risk, responsibilities, evidence and acceptance criteria, and explains how the plan should govern validation through implementation, operation, change and retirement. Read Article →
- Computerised System Validation in Pharmacovigilance Computerised system validation in pharmacovigilance is the documented, risk-proportionate demonstration that systems supporting regulated safety activities are fit for their intended purpose and remain controlled throughout their lifecycle. This article explains the EU pharmacovigilance basis for validation, distinguishes PV requirements from GMP and FDA device guidance, and shows how requirements, testing, change control, data integrity, supplier oversight and governance combine to maintain a validated state. Read Article →
- 21 CFR Part 11: Electronic Records and Electronic Signatures in Pharmacovigilance Learn how to determine whether a pharmacovigilance record or signature falls within 21 CFR Part 11, what the regulation requires, how FDA guidance affects interpretation, and how to implement proportionate controls. Read Article →