Pharma AI Authority™ — proof for every pharma AI action
Pharma teams run AI across discovery, clinical, safety and quality. KYE Protocol™ proves whether each pharma AI action — a nucleic-acid synthesis order, a trial-protocol decision, a safety-signal disposition, a batch or clinical-result release — was authorised, purpose-bound, evidenced, replayable and final. A model can be validated to GxP and still act without authority.
KYE™ is not another lab platform, CTMS, safety database or model-validation tool. It is the authority layer underneath them: the runtime control point that decides whether an AI agent's proposed pharma action has authority, then emits a signed, replayable record. GxP asks whether the system is validated; KYE™ asks whether this specific action was authorised, by whom, under which SOP version — the answer a regulator can replay years later.
The line: a validated model vs. an authorised action
Your quality system validates the software and qualifies the model. KYE™ governs the action boundary: the instant an AI agent proposes a consequential pharma action, KYE™ checks actor, mandate, purpose, data scope, SOP version, policy, risk, human sign-off and finality, then returns allow / deny / require_approval / suspend.
The authority questions are banking-grade for regulated pharma: Is this agent allowed to release a batch, disposition a safety signal, or approve a protocol deviation? Who delegated that authority? Is the action advisory, or did it update a validated system of record? Can the decision be replayed for an inspector, sponsor, ethics committee or litigation years later? Every KYE™ answer maps to a real regulatory spine and a signed evidence record.
Already shipped: four pharma & life-sciences Authority Packs™
You do not adopt a new framework — you bind the packs that already exist. Each pack governs a pharma action vertical against its real regulatory spine: EMA GVP, ICH E6(R3) GCP, FDA 21 CFR Part 11, OECD GLP, FDA 21 CFR Part 58 and nucleic-acid synthesis screening. Pick the verticals your AI touches.
Five pharma governed agents, each authority-checked at the action boundary
Where you deploy AI, KYE™ ships the per-action authority agents that govern it. Each is a first-class principal with a delegation chain, a KYE Evidence Pack™ and a Replay-Proof™ trail — so a quality lead, inspector or sponsor can reconstruct any decision offline.
- Clinical Action Authority Agent — accept, deny or adjust a clinical decision
- Clinical Trial Conduct Authority Agent — protocol, eligibility and deviation authority
- Drug Discovery Research Authority Agent — nonclinical study-data-integrity authority
- Genetic Sequencing Authority Agent — synthesis-order and sequence-of-concern screening
- Pharmacovigilance Action Authority Agent — post-market safety-signal disposition
For pharma AI platforms & digital R&D labs
If you run an AI platform across discovery, clinical operations, safety or quality, KYE™ is the authority layer beneath your agents. Your platform orchestrates the science and the workflow; KYE™ proves the workflow stayed inside authority. This governs the decision, not the bench — KYE™ never runs the assay, the trial or the model.
The integration is a runtime check: your agent proposes a consequential action, KYE™ evaluates actor, mandate, purpose, data scope, SOP version, policy, risk, human sign-off and finality through the Evidence Pack™ chain, and returns a verdict your platform continues, escalates or blocks on. A digital R&D lab can execute; KYE™ decides whether execution has authority.
For CROs, sponsors & regulatory affairs
If you run trials, own safety, or file with regulators, KYE™ governs every consequential AI action across the study and the submission. A validated summary is not the same as an authorised release, and an AI can draft a perfect narrative and still lack authority to disposition a case or release a result.
KYE™ binds each agent to a mandate and a purpose, then gates the moment it tries to disposition a safety signal, approve a protocol deviation, release a clinical result or advance a submission decision. Every gated action emits a signed record that an inspector, sponsor, ethics committee or litigation can replay — so "the AI did it" is never the end of the trail.
One authority spine under every pharma AI action
Every pack and agent above resolves to the same runtime primitives — so you govern discovery, clinical, safety and quality through one control point, not four. KYE™ reuses these primitives; it never reimplements them per vertical.
The result is one provable answer for every patient- and product-impacting action: who had authority, for what purpose, with what evidence, and whether it became final under Authority Finality™.