Litewave AI - GMP Intelligence Platform for Pharma Manufacturing
Litewave AI is an AI-native GMP Intelligence Platform for pharmaceutical and API manufacturing, delivered as SaaS from AWS via AWS Marketplace. Start with Batch Review; Compliance (Digitize + Comply): Litewave overlays your existing records and systems - paper batch records, MES, LIMS, and ERP, to unify GMP evidence into a traceable, AI-ready fabric. Generate AI-assisted Batch Verification Reports with configurable GMP checks, enable review-by-exception, and surface data integrity gaps to accelerate batch disposition and improve inspection readiness. As you expand, Litewave can connect compliance to performance by correlating supplier variability to yield, surfacing golden-batch drivers, and highlighting process/equipment risk signals. Designed to support 21 CFR Part 11 and EU Annex 11 expectations with governance controls such as role-based access and audit trails. Private/on-prem deployments, custom integrations (QMS/ERP/LIMS), and additional modules are available via Private Offer.