Solutions

Accelerate quality and manufacturing workflows

Four jobs a quality organization has to do on every batch, automated across the documents and systems you already run. Litewave reads the records, applies your checks, and hands your team the exceptions with the evidence attached.

Batch Review & Release

Litewave applies your master record, your specifications and your release criteria to every operation in every batch, then gives QA a review-by-exception file with the evidence attached. It runs against your eBPR and MES data, and against handwritten paper that most systems cannot read at all.

Deviation Investigations

Litewave builds the timeline from the source records, retrieves every prior event that resembles this one, and proposes root cause and CAPA candidates with the evidence for and against each. Your investigator decides.

Supplier Quality & CoA Review

Every incoming certificate is checked line by line against your approved specification, your supplier qualification status and that supplier’s own history, so an out-of-spec result, a missing test or a quietly changed method is caught at receiving rather than at release.

Quality Analytics

Litewave turns the records you already execute into structured quality data, so yield, deviations, OOS rates, supplier performance and cycle times are live all year instead of reconstructed once at review time.

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.

Your data never trains our models

Documents are never sent to third-party AI providers and are never used to train any model, ours or anyone else’s.

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

Meets European GMP expectations for computerised systems used in regulated manufacturing.

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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