TFives offers a compliance and evidence platform that enables life-sciences teams to adopt AI and agentic workflows across quality, regulatory, clinical, and commercial operations. The platform records every AI-assisted decision on a single case record, checks agent actions against approved contexts of use, and integrates with existing RIM and eQMS systems without replacing them. Its FIVES framework spans the full pharmaceutical product lifecycle, from discovery through post-market surveillance.
Funding
Funding not disclosed
Founders
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
- ComplianceIQ for validating AI models against 156 standards and managing model lifecycle documentation
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