Computerized System Validation/Computerized Software Assurance (CSV/CSA)
Our team leverage a risk-based validation approach that meets regulatory requirements that are fully aligned with industry standards and GxP gudielines for CSV/CSA.
Clintask CSV/CSA services ensure that all electronic records, signatures, and system operations are accurate, secure, and fully traceable.
Our process features comprehensive system testing, stringent validation protocols, and continuous monitoring to mitigate risks to quality .
Assessment fo Critical needs
SDLC Framework,Validation Plan
User specification requriments
Qualification protocols (IQ/OQ/PQ) / Test Scripts
21 CFR Part 11 Assessment GAMP Categorization
CSV Services for pharma
Clintask delivers full-spectrum Computer System Validation (CSV) solutions across laboratory, manufacturing, and clinical systems, ensuring compliance with FDA, MHRA, and ICH GxP standards. Our risk-based validation methodology aligns with CSA principles, supported by Data Integrity (ALCOA+), 21 CFR Part 11, and Annex 11 frameworks. We also integrate GMP, GLP, and GCP audit readiness, enabling sponsors and CROs to achieve continuous regulatory assurance.
European Medicines Agency (EMA)
Medicines and Healthcare products Regulatory Agency
US FDA Regulations
Central Drugs Standard Control Organisation (CDSCO)
