TFives
TFives provides an evidence-first AI governance platform for life-sciences companies, recording every governed AI action as it happens—including the rule applied, source evidence, and human approver—to create audit-ready proof for regulatory inspections. The platform works alongside existing QMS and RIM systems, checking whether AI agents are allowed to act within approved contexts and routing unauthorized actions to human review. It supports GxP and AI regulations including 21 CFR Part 11, EU GMP Annex 11, and the EU AI Act.
- Regulatory & Compliance Technology
- Artificial Intelligence
- AI Agents
- Software Only
- Healthcare Technology
Funding
Founders
Founder details are not available yet.
Product
Problem
Life-sciences organizations face growing regulatory pressure as they adopt AI and agentic workflows, yet traditional compliance systems were not designed to handle machine-speed decision-making. Pharma teams struggle to produce audit-ready evidence for AI-assisted decisions, especially across quality, regulatory, clinical, and commercial operations, creating bottlenecks that slow innovation and delay patient access to therapies.
Solution
TFives provides an evidence-first AI governance platform that records every AI-assisted decision as it happens on a single case record. The platform checks whether an AI agent is allowed to act within its approved context of use, and stops or routes unauthorized actions to an accountable human. It captures rules applied, source evidence, human sign-off, and replay capabilities, generating traceable audit-ready documentation. TFives works alongside existing RIM and eQMS systems, connecting approved AI context, controlled data and tools, human review, and evidence trail without replacing the systems teams already rely on. The platform spans the complete product lifecycle from discovery through lifecycle management, ensuring compliance continuity across all stages.
Target Audience
Primary customers are pharmaceutical and life-sciences companies across discovery, clinical development, regulatory affairs, manufacturing, and commercial operations, including teams responsible for quality, regulatory, clinical, and commercial compliance.
Features
- System of Proof architecture that captures rule applied, source evidence, human sign-off, and replay functionality for every AI-assisted decision
- Allowed-to-Act engine that evaluates agent actions against approved contexts of use and halts unauthorized actions for human review
- Execution Integrity layer that routes conflicts between AI output and encoded rules to a person for review before the event is sealed on the proof record
- ComplianceIQ for validating AI models against 156 standards and managing model lifecycle documentation
- AskRexi conversational chatbot providing multi-jurisdictional regulatory intelligence and post-approval change guidance
- ClinoxisCore marketplace for GxP-compliant data management from discovery through clinical development
- RegIQX for automated pharma validation within CAPA workflows, eCTD generation, and pre-approval inspection readiness
- CommercialCore for HCP and promotional compliance with Sunshine Act tracking
- DataGovernanceIQ supporting risk-based assurance of AI-enabled workflows through evidence and controls
- Built to support ALCOA+, 21 CFR Part 11, EU GMP Annex 11, FDA Computer Software Assurance, EU AI Act, and FDA's draft AI credibility framework