TFives provides the compliance and evidence foundation that enables life-sciences teams to safely adopt and scale AI and agentic workflows across quality, regulatory, clinical, and commercial operations.
Define intended purpose, users, boundaries, and accountability.
Apply governed access, approved sources, and controlled tooling.
Maintain traceable records for review, assurance, and change control.
Every AI-assisted decision, recorded as it happens on one case record.
Before an AI agent acts on a high-consequence decision, TFives checks whether it’s allowed in its approved context of use. Allowed actions proceed with evidence recorded. Actions that aren’t allowed are stopped and routed to an accountable human.
Agents move at machine speed. Humans stay accountable where it legally matters.
TFives works alongside existing RIM and eQMS systems, connecting approved AI context, controlled data and tools, human review, and traceable evidence without replacing the systems teams already rely on.
AI may assist within approved context, with standard monitoring and accountable ownership.
A qualified reviewer checks outputs before downstream use and records the decision.
Independent approval, controlled evidence, and defined escalation are required before use.
No AI use outside approved context, data boundaries, required human oversight, or documented controls.
Practical guidance for governing AI and agentic workflows with evidence, controlled access, and accountable human oversight.
A single record for every AI-assisted decision: the rule that applied, the source evidence, the human who signed, and a replay available any time after. It works beside your existing systems, never replacing them.
Before an AI agent acts on a high-consequence decision, TFives checks it against the approved context of use. Allowed actions proceed with evidence; others are stopped and routed to a human.
Yes. TFives supports regulatory affairs, pharmacovigilance, manufacturing quality, medical affairs and commercial compliance on one platform.
