Industries

Same engine, different rulebooks

The artifacts change name across industries. The problem does not: someone has to read the records, in whichever systems hold them, and prove they were right. Litewave is configured to the standard your site is actually held to.

Pharmaceutical & Biotech

Batch review, deviation investigations, supplier quality and product quality review, automated across the batch records, analytical data and quality systems you already run. In production today at an FDA inspected, WHO-GMP certified API manufacturer.

Food & Beverage

Your food safety plan is only as good as the records that prove you executed it. Litewave reads CCP logs, sanitation records, production sheets and supplier certificates, checks them against your plan and your scheme requirements, and surfaces the gaps before your auditor does.

Dietary Supplements

21 CFR Part 111 asks you to prove three things on every batch: that you followed the master manufacturing record, that you verified what came in the door, and that the finished product meets its specifications. Litewave checks all three using the records you already keep, and the same three carry into the EU and UK, where supplements are regulated as food rather than under a Part 111 style GMP rule.

Cosmetics & Personal Care

MoCRA turned cosmetics recordkeeping from a best practice into a legal obligation with FDA record access attached, and an EU or UK Responsible Person carries a comparable evidentiary burden. Litewave reads your batch documentation, raw material certificates and safety files, checks them against your specifications and against ISO 22716, and keeps the evidence assembled for whichever market asks.

Built for validated environments

Your data stays where your auditors expect it

Deploy in your environment

Your cloud, your data center, on the plant floor, or fully air-gapped. The same agents run identically in all four, because the models are open-source and served inside your perimeter, so inference never leaves it.

Your data never trains our models

Documents are never sent to third-party AI providers, and they never train a model that any other customer touches. Where a model does adapt to your site, the handwriting engine learning your operators, that loop is closed inside your deployment and what it learns stays yours.

21 CFR Part 11

Electronic records, electronic signatures and complete audit trails on every action, built to ALCOA+ data integrity principles.

EU GMP Annex 11, and building for what is next

Meets the currently effective Annex 11 expectations for computerised systems. We are building to the draft revised Annex 11 and the draft Annex 22 on AI while both remain in consultation, so nothing here is claimed as compliance with a standard that is not yet in force.

Validated like the computerised system it is

The validation documentation your quality unit needs to qualify Litewave under its own CSV or CSA procedure, risk-based and scoped with you during procurement, alongside Part 11 and Annex 11 assessments covering audit trail, electronic signature and access control.

AI governance you can inspect

Context of use, model versions, performance monitoring and change control are documented in line with the EMA and FDA guiding principles of good AI practice in drug development, so the model sits inside your quality system rather than beside it.

Advised from both sides of the inspection

A former FDA division director who edited the Investigations Operations Manual, the field guide its investigators follow on site. A former FDA investigator who then decided enforcement outcomes at CDER. A Qualified Person who certifies batch release under EU GMP. They advise in a personal capacity, and FDA does not endorse products or companies.

Evidence on every flag

Every extraction, check and recommendation links back to its source page. Nothing asserted is unverifiable.

Human in the loop by design

Agents propose, qualified people approve. Litewave never dispositions a batch on its own.

See it run on one of your own records

Bring a batch record, a stack of supplier certificates or a deviation file. We will show you what Litewave finds and what it cites as evidence.

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