What is CSV?
Computer System Validation explained — GMP lifecycle, V-model traceability, OQ thinking, and fitness for intended use.
Read guideGxP & validation resources
Central hub for GXPLearn public educational content — validation fundamentals, lifecycle guidance, and training paths for QA, validation, and automation professionals.
Validation fundamentals
Core definitions and comparisons for computer system validation and FDA-aligned assurance thinking.
What is CSA?
FDA Computer Software Assurance explained — risk-based testing, six-step framework, and proportionate evidence.
Read guideCSV vs CSA
Compare traditional validation lifecycle depth with FDA risk-based assurance — when each lens applies and how they coexist.
Compare approachesValidation lifecycle & planning
End-to-end software validation from defined user requirements through maintained validated state — including planning artefacts and qualification layers.
Validation lifecycle explained
FDA GPSV lifecycle principles — requirements, design review, V-model traceability, user site testing, and change control.
Read guideIQ, OQ & PQ explained
Installation, operational, and performance qualification — how qualification layers fit the validation lifecycle.
Read guideGAMP 5 categories explained
How GAMP 5 software categories (1, 3, 4, 5) scale validation effort, supplier leverage, testing strategy, and CSA adoption.
Read guideValidation V-Model explained
How the V-Model connects URS, design specifications, IQ/OQ/PQ, and traceability in CSV and CSA workflows.
Read guideUser Requirements Specification (URS) guide
What a URS is, typical contents, traceability to IQ/OQ/PQ, and how requirements anchor CSV and CSA validation.
Read guideValidation plan guide
How validation plans govern scope, deliverables, testing strategy, traceability, and qualification across the CSV lifecycle.
Read guideData integrity
ALCOA+ principles, audit trails, and record defensibility across GxP computerised systems.
What is data integrity in GxP?
ALCOA+ expectations, audit trail thinking, and why complete, consistent, and accurate records underpin CSV, CSA, and GMP compliance.
Read guideTraining
Interactive simulation paths for practising CSV, CSA, and validation judgement inside GXPLearn.
CSV & CSA simulation training
Practise risk-based validation scope, evidence review, and CSA judgement through guided modules.
View training pathValidation engineer training
Lifecycle context, OQ and deviation practice, and Validation Digital Twin capstone scenarios.
View training pathPharma validation training
Validation training for pharma QA and automation teams — CSV/CSA thinking and capstone review.
View training pathMore guides
GxP training for individuals
Free foundation modules, professional curriculum, and self-paced practice for career changers and practitioners.
Read moreData integrity and audit trail practice
ALCOA+ thinking, audit trail review, and record defensibility in investigation scenarios.
Read moreDeviation and investigation training
Evidence-first workflows, impact assessment, and CAPA thinking for QA and manufacturing teams.
Read moreWhat is GMP training — and what it is not
How practical GxP literacy differs from site SOP sign-off and validated LMS programmes.
Read moreInteractive training vs passive e-learning
When workflow practice beats slide decks for CSV/CSA judgement and evidence review.
Read moreReady to practise regulated workflows?
Choose the path that fits — start with free foundation modules or discuss a team licence for your organisation.
For individuals
Start with the free foundation modules and upgrade when you are ready for simulation labs and professional scenarios.
For businesses
Request a business demo or pilot discussion for team/site licensing, standalone export, and onboarding use cases.