GxP SaaS, AI & Digital Systems
Validation, AI evaluation and compliance strategy for software used in regulated processes, records and decisions.
Where We Help
Intended-use definition, risk-based validation and CSA, 21 CFR Part 11, EU Annex 11, audit trails, electronic signatures, data integrity and supplier responsibilities. For AI and Regulatory Technology products, support can include benchmark design, output evaluation, rubrics, acceptance criteria, hallucination and unsupported-inference testing, human oversight, traceability, GxP AI governance and regulated-customer readiness.
The Decision We Protect
Whether the system—including AI-generated outputs—can be relied on for its regulated intended use, whether performance and validation evidence are proportionate to risk, and whether human oversight, traceability, customer responsibilities and supplier controls are clear enough to withstand audit scrutiny.