TFives - 2026 Pricing, Features, Reviews & Alternatives

TFives is AI governance and regulatory compliance software for pharmaceutical, biotech, medical device, CRO, and life sciences organizations. It gives quality, regulatory, clinical, medical affairs, and commercial teams the controls and evidence they need to adopt and scale AI and agentic workflows safely in GxP-regulated environments.

At the core is ComplianceIQ, a single compliance management engine that applies the right regulations, controls, and evidence capture to every AI workflow, from business case and design through deployment, monitoring, and retirement. On top of ComplianceIQ, TFives delivers role-based workflows with domain depth: AskRexi for governed regulatory intelligence, DataGovernanceIQ for controlled data and access, RegIQX for validation, investigation, and CAPA evidence, ClinoxisCore for compliance resources, CommercialCore for commercial operations, and PromoIQ for promotional and MLR compliance. Each team works in a workflow built for its role, while ComplianceIQ surfaces the applicable rules continuously.

ComplianceIQ powers the TFives System of Proof. Every AI-assisted decision is recorded on a single case record with the rule that applied, the source evidence, the human who approved it, and a replay available at any time. The Allowed to Act control checks each high-consequence AI action against its approved context of use: permitted actions proceed with evidence recorded, and anything out of scope is stopped and routed to an accountable human. TFives also detects when a deployed model drifts from its qualified configuration. Oversight is risk-based, so review depth scales from standard monitoring for low-risk use to independent approval for high-risk decisions. On demand, teams export a signed inspection package that confirms all nine ALCOA+ data integrity criteria.

For commercial teams, PromoIQ reviews promotional content and brand websites against FDA and FTC rules before and after MLR review, explaining each finding with the rule, citation, and fix. It also catches the regulatory domino effect, where one technical defect, such as safety information hidden from screen readers, breaks FDA fair-balance, WCAG accessibility, and FTC disclosure rules at once.

TFives supports governance, risk and compliance (GRC) programs and works alongside existing RIM and eQMS systems rather than replacing them. It is available as SaaS, private cloud, or on-premises, with a REST API. TFives is SOC 2 compliant and was named a finalist for AI Innovation in Data Governance & Privacy at the 2026 Fierce AI Innovation Awards.