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TFives

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Fives is an evidence-first AI governance and regulatory compliance platform built for pharmaceutical and life sciences companies. It gives quality, regulatory, clinical, medical affairs, and commercial teams the controls and audit-ready evidence they need to safely adopt and scale AI and agentic workflows in GxP-regulated environments. At the core is ComplianceIQ, a single compliance engine that applies the right rules, controls, and evidence capture across every workflow. On top of it, TFives delivers persona-based workflows with domain depth for regulatory affairs, quality and manufacturing, clinical and R&D, medical affairs and safety, data governance, and commercial and promotional review. Each team works in a workflow built for its role, while ComplianceIQ surfaces the applicable rules and compliance requirements continuously. ComplianceIQ powers the TFives System of Proof: every AI-assisted decision is recorded on a single case record that captures the rule that applied, the source evidence, the human who signed off, and a replay available at any time. Its "Allowed to Act" control checks each high-consequence AI action against an approved context of use. Permitted actions proceed with evidence recorded, and anything outside scope is stopped and routed to an accountable human. Oversight is risk-based, so review depth scales from standard monitoring for low-risk use to independent approval for high-risk decisions. TFives works alongside existing RIM and eQMS systems rather than replacing them. TFives is SOC 2 compliant and was named a finalist for AI Innovation in Data Governance & Privacy at the 2026 Fierce AI Innovation Awards.

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