Solutions
Accelerate quality and manufacturing workflows
The jobs a quality organization has to do on every batch, and on the document set behind it, automated across the systems you already run. Litewave reads the records, applies your checks, and hands your team the exceptions with the evidence attached.
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 against 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
A risk-based validation package written to GAMP 5 second edition and Annex 15 expectations: specifications and traceability matrix, IQ, OQ and PQ protocols with executed evidence, and a supplier assessment pack, so your quality unit can qualify Litewave under its own CSV or CSA procedure.
AI governance you can inspect
Context of use, model versions, performance monitoring and change control are documented against 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.
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.