AI-Enhanced Computer System Validation (CSV) & Computer System Assurance (CSA)

Modern, risk-based, audit-ready validation
We validate and maintain GxP-critical IT systems using a risk-based, AI-supported approach, fully aligned with GAMP 5 (2nd edition), FDA 21 CFR Part 11, Annex 11, and CSA principles.
Our team develops end-to-end validation strategies, lifecycle documentation, and ensures continuous inspection readiness — reducing manual effort while strengthening compliance.

ALCOA+ compliance powered by intelligent assessments
Data integrity is at the core of every regulated process. We perform Data Integrity Gap Assessments, create detailed data flow diagrams, and conduct mock audits to ensure compliance with the latest FDA, EMA, MHRA, and WHO expectations.
Our AI-supported analysis accelerates the identification of risks and ensures robust, traceable, and secure data management.

Inspection readiness with no surprises
We prepare organizations for GMP, GDP, GCP, and GLP inspections through targeted mock audits, CAPA strategies, SOP creation, and quality risk assessments.
Our structured approach ensures your teams, processes, and documentation are aligned with global regulatory expectations — from readiness assessments to closing findings.

Smarter processes, stronger compliance
We redesign and optimize business processes across the life science value chain, integrating digital tools and efficient workflows.
Our training programs cover CSV/CSA, Data Integrity, GAMP 5, AI in Validation & Quality, and practical compliance topics — enabling teams to work faster, smarter, and fully aligned with regulations.

Leadership for complex, cross-functional transformation
From SAP harmonization to eDMS deployments, MES rollouts, and cloud qualification — we manage global projects with precision.
Our expertise spans validation, risk management, stakeholder alignment, testing strategy, and change management, ensuring projects deliver compliant, reliable results.

Implementing future-ready, compliant digital solutions
We support organizations on their journey towards digitization, including:

• Electronic Records & Signatures (ERES)
• Paperless validation and digital lifecycle documentation
• eDMS and RIM system deployments
• SAP S/4HANA and cloud-based GxP solutions
• MES, LIMS, and data governance frameworks
• AI-assisted tools & regulatory-safe implementation
   

Our approach ensures that digital solutions remain compliant, efficient, and inspection-ready: with human oversight and full traceability.

Ready to elevate compliance and accelerate digital transformation?
Contact us to discuss how Qualitice can support your regulatory, validation, and quality needs.