AI-powered automation for documentation generation, test execution, and GxP risk management. Regulatory compliance built into every step.
From specification documents to the final report — no regulatory gaps.
URS, FRS, IQ, OQ, PQ and RTM generated automatically from the system under validation.
IQ/OQ/PQ test scripts executed by AI agents with real-time evidence capture and deviation management.
Automatic categorization and risk matrix generation with documented mitigating controls per GAMP5 guidelines.
AI-assessed change impact with full traceability to affected validation documents and revalidation triggers.
Immutable record of all actions with timestamp, user and electronic signature compliant with 21 CFR Part 11.
Native connectors to Veeva Vault, OpenText, SharePoint and LIMS for real-time document synchronization.
Every document generated, every test executed, and every decision made is traced and referenced to the applicable regulatory requirements. Ready for FDA, EMA and national authority inspections.
We connect to the system under validation and extract specifications, configuration and business flows.
AI generates URS, FRS, validation plan and IQ/OQ/PQ protocols tailored to your regulatory context.
Agents execute tests, capture evidence and manage deviations with complete traceability.
Electronically signed validation report archived in your EQMS with a complete audit trail.
Privacy, control and traceability baked into the architecture.
Models fine-tuned on regulatory documentation (FDA, EMA, ISPE) to produce technically accurate, inspection-ready content.
Multi-agent orchestration to run complete validation protocols, manage decisions and escalate deviations without manual intervention.
On-premise or private VPC deployment. Data never leaves your infrastructure. Encryption in transit and at rest with customer-managed keys.
Certified connectors with the industry's leading systems to eliminate data silos and ensure end-to-end traceability.
Request a personalized demo and we'll show you how Qualitech.ai works with your specific system.