Trust Center
Compliance you can inspect.
Every page on this site makes the same claim: one platform, 21 CFR Part 11 from day one. This page is the evidence behind it. How records are kept, how deployments are validated, and what controls AI agents run under.
Oral solid dosage, sterile, API, and biotech
FDA, EMA, ANVISA, TGA, and Swissmedic frameworks
No failed deployments across customer rollouts
21 CFR Part 11
Electronic records, built for inspection.
Part 11 compliance is not a certificate on a wall. It is architecture: how every record is created, signed, changed, and retained. These controls ship in every Leucine product, on one shared data model.
Electronic signatures
Every approval carries a 21 CFR Part 11 e-signature with identity verification and a meaning statement, so who signed, and what the signature meant, is never ambiguous.
Tamper-evident audit trails
Every create, edit, and signature is attributable, timestamped, and system-generated. The audit trail is not a report someone maintains; it is a record no one can edit.
Role-based access control
Individual credentials and role-based permissions on every document and data point, so every action traces to one person with the authority to take it.
ALCOA+ by design
Records are captured at the moment of the activity and sequenced so steps cannot be skipped, reordered, or backfilled. Attributable, legible, contemporaneous, original, accurate.
Built for inspection across 10+ regulators: FDA, EMA, MHRA, ANVISA, TGA, Swissmedic, and others, on the platform behind 400+ GMP facilities.
Validation
Validation is a phase, not a promise.
100% Go-live Success is the output of a method. Validation is a named, scheduled phase in every Leucine deployment, producing the documentation your quality unit needs to defend the system in an inspection.
Risk-based, GAMP 5 aligned
Testing effort concentrates where patient and data-integrity risk actually lives, consistent with FDA's computer software assurance thinking, instead of exhaustive scripts that prove nothing.
A pack your quality unit can file
Each deployment delivers the evidence a vendor-qualification file expects: risk assessments, functional specifications, qualification protocols, and full traceability.
Multi-site without repetition
A global validation baseline with site-specific supplements, so a 30-facility programme reuses evidence instead of running 30 identical validation projects.
How a deployment runs
Scope and configure
Your processes, master data, and integrations mapped onto pre-configured GxP templates, with your SMEs in the room.
Validate
IQ, OQ, and PQ executed against a risk-based protocol. Documentation is handed to your quality unit as it is produced, not at the end.
Go live
Credentialed users, hypercare on the floor, and inspection-ready records from the first entry. First modules go live in as little as 8 weeks.
Expand
The validated baseline carries to the next site with site-specific supplements, so each rollout is faster than the one before it.
This is the plan behind 100% Go-live Success. No failed deployments across customer rollouts.
AI Governance
Agents act. People decide.
An AI-native platform in GxP needs more than model quality. It needs governance a quality unit can defend: who approved what, on what reasoning, with what record. These are the controls Leucine agents run under.
Human-in-the-loop, with reasoning
Agents advise, QA decides. Every recommendation carries the reasoning and source data behind it, so the reviewer approves with a documented basis, not on trust.
Agent actions on the Part 11 trail
Everything an agent does is logged to the same tamper-evident audit trail as human actions: attributable, timestamped, and reviewable in an inspection.
Your data stays yours
Customer data is not used to train models for other customers, and it does not leave the boundaries you approve.
Working with FDA, not around it
Leucine participates in the FDA Emerging Technology Program, engaging with the agency directly on how agentic AI runs inside regulated manufacturing.
Put these claims in front of your quality unit.
Schedule a demo and ask the hard questions, or request the validation pack for your vendor-qualification file.