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 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.