Life Sciences
Sovereign, provable AI that protects your IP and your data integrity
Research, clinical, and manufacturing teams have AI pilots that could compress discovery and trial timelines, but they stall on two immovable requirements: your proprietary molecules and trial data cannot leave your walls, and every AI-touched record has to hold up to a data-integrity audit. NuDay keeps IP encrypted and in your control, runs on-prem or air-gapped for your most sensitive R&D, and produces the attributable, tamper-evident records your QA and regulatory teams need.
Your formulations and trial data stay in your walls, ciphertext to everyone else.
Every AI-touched record is attributable, contemporaneous, and tamper-evident by construction.
Why it stalls
Why life sciences AI stalls in review
The pilots work. What blocks them is four things QA, regulatory, and IP owners cannot get comfortable with, and what changes each conversation:
Proprietary molecules, formulations, and trial data leak into the model context and agent memory. NuDay encrypts the agent's data layer, and for the crown jewels you run the model on-prem so IP never leaves.
Data integrity cannot be proven for AI-generated or AI-touched records. Records are attributable, contemporaneous, and tamper-evident by construction, mapping to ALCOA+.
21 CFR Part 11 requires attributable electronic signatures and an audit trail for automated actions. Cryptographically signed tool execution bound to a verified identity provides both.
Lab-automation and GxP agents could act outside validated parameters. Tools and guardrails are signed and cryptographically bound, so an unverified action halts instead of running.
IP sovereignty
Keep the IP in your walls
A drug program is a decade-long secret. NuDay is built to keep that IP inside your control for as long as it matters.
IP stays put
Run on-prem or air-gapped for R&D so molecules and formulations are never sent to a third-party cloud or external LLM.
You hold the keys
Bring your own keys on hybrid; on-prem keeps key custody entirely in-house.
Built for long-lived secrets
Post-quantum encryption keeps drug IP resistant to harvest-now, decrypt-later over the decades that matter.
The evidence
The evidence your frameworks ask for
NuDay does not grant validation or compliance. It produces the concrete, provable evidence your QA and regulatory teams map to each requirement.
21 CFR Part 11
Attributable electronic records and signatures plus a tamper-evident audit trail for every automated action an agent takes.
GxP (GMP, GLP, GCP)
Agents are constrained to signed, validated actions across manufacturing, laboratory, and clinical practice; unverified steps do not run.
ALCOA+ data integrity
Every record is attributable, legible, contemporaneous, original, and accurate, produced that way by construction rather than reconstructed after the fact.
Computer system validation (GAMP 5)
Deterministic, signed execution and immutable logs that support and evidence a validated state for AI-enabled systems.
EU Annex 11
Access controls, audit trails, and data integrity for computerised systems used in EU GMP environments.
Clinical trial data (GCP and GDPR)
Subject data is encrypted and access-scoped, and can be kept in-region for cross-border trials.
What review gets
What QA, regulatory, and IP owners get
Not a promise that the AI is validated, but the evidence to decide for themselves.
Attributable per-action records
Which tool ran, under whose authority, with what inputs, contemporaneously and tamper-evident.
IP encrypted at rest
Molecules, formulations, and trial data are ciphertext, per record, with independent keys.
Validated, signed execution
Agents run only signed, authorized actions, so a validated state stays validated.
For pharma, biotech, and CROs
Get your stuck life sciences AI moving.
Bring your pilot and your reviewers. We will walk through how your IP stays in your walls, how records meet data-integrity expectations, and the evidence your QA and regulatory teams receive.