Computerised System Validation
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Articles in this section
5- User Requirements Specifications (URS) in Pharmacovigilance Learn how to write effective User Requirements Specifications (URS) that form the foundation of successful validation projects and support inspection-ready pharmacovigilance systems. Read Article →
- Functional Specifications and Design Specifications in Pharmacovigilance Learn how business requirements defined in the User Requirements Specification are translated into functional and technical system designs while supporting risk-based validation and regulatory compliance. Read Article →
- Validation Testing in Pharmacovigilance: IQ, OQ, PQ and User Acceptance Testing Learn how validation testing provides objective evidence that pharmacovigilance computerised systems are fit for their intended use through risk-based qualification and testing strategies. Read Article →
- Traceability Matrix in Computerised System Validation Learn how traceability matrices connect business requirements, risk assessments, specifications, validation testing and objective evidence throughout the lifecycle of validated pharmacovigilance systems. Read Article →
- Computerised System Validation Plan Learn how to develop a Computerised System Validation Plan that defines validation strategy, responsibilities, deliverables and lifecycle activities for regulated pharmacovigilance systems. Read Article →