Litewave AI is building the AI-native industrial operating system for regulated manufacturing.

We help pharmaceutical and life sciences manufacturers digitize workflows, improve compliance, and unlock quality and operational intelligence across batch records, quality documents, and plant systems. Litewave connects data across paper records, scanned documents, SOPs, ERP, MES, LIMS, QMS, DMS, and other siloed systems to create an audit-ready foundation for faster, more reliable decisions.

Built for GxP environments, Litewave is designed to support ALCOA+ principles and requirements aligned with 21 CFR Part 11 and EU Annex 11 / Annex 22, with a strong focus on traceability, explainability, human oversight, and data integrity.

Our privacy-first, deploy-anywhere platform runs in cloud, on-prem, or hybrid environments, so manufacturers can adopt AI while keeping control of sensitive data and working within existing validation and compliance constraints. No rip-and-replace required.

Founded by leaders from HPE GreenLake Private Cloud and experts from UC Berkeley EECS, AWS AI, AMD, and Salesforce, Litewave brings secure, multimodal AI agents to regulated operations, helping teams stay compliant, explainable, and operationally smarter.

Litewave AI

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