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 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 →
- 21 CFR Part 11: Electronic Records and Electronic Signatures Explained Understand 21 CFR Part 11, when it applies, what it requires, how FDA interprets its scope, and how organisations implement electronic records and electronic signatures in regulated pharmacovigilance systems. Read Article →
- Computerised System Validation in Pharmacovigilance A comprehensive guide to Computerised System Validation (CSV) in pharmacovigilance covering lifecycle validation, intended use, regulatory expectations, risk-based validation, Computer Software Assurance (CSA), data integrity and practical implementation. Read Article →