Litewave AI - GMP Intelligence Platform for Pharma Manufacturing

Litewave AI is an AI-native GMP Intelligence Platform for pharmaceutical and life sciences manufacturing. We help Quality and Operations teams digitize GMP records, surface data integrity and compliance risks, and improve performance-inspection-ready by design.

Litewave unifies evidence across paper batch records, scanned documents, and siloed systems (MES, LIMS, ERP, DMS) to create a secure, traceable "GMP evidence fabric" without rip-and-replace. Starting with Regulatory Agility, Litewave enables review-by-exception, detects GMP data integrity gaps, and generates AI-assisted Batch Verification Reports-a configurable set of GMP checks performed for every batch-to accelerate batch disposition and improve inspection readiness. As you expand, Litewave connects compliance to performance by correlating supplier variability to yield, surfacing "golden batch" drivers, and highlighting process and equipment risk signals.

Human-in-the-loop by design: Litewave supports review-by-exception-AI agents surface potential issues and supporting context; Quality reviewers remain in control of final decisions and approvals. Like any AI-based decision-support tool, Litewave may surface false positives and may not identify every potential issue; it augments Quality workflows and does not replace required human judgment.

Built for pharma and aligned with ALCOA+ expectations, Litewave is designed to support customer compliance with 21 CFR Part 11 and EU Annex 11 expectations through governance controls such as role-based access, audit trails, and traceability. (Customers configure validation and procedural controls consistent with their GxP program.)
CSV / Validation (GxP Readiness)
Customers operating under GxP typically require Computer System Validation (CSV) and site-specific validation documentation/execution prior to regulated production use. Litewave supports customer validation programs with a validation support package (e.g., templates, evidence artifacts, and guided execution support) via AWS Marketplace Private Offer. Scope and deliverables vary by customer environment, intended use, and change control requirements.

Is CSV (Computer System Validation) included in the subscription? CSV execution is typically customer-managed under the customer's QMS. Litewave provides validation support materials and guided execution services via AWS Marketplace Private Offer; scope and deliverables vary by environment and intended use.

Private Offers & Custom Terms
Enterprise customers often require specific deployment, security, and commercial terms. For private cloud or on-prem deployments, private networking requirements, custom integrations (QMS/ERP/LIMS), higher throughput, multi-year pricing, CSV/validation support packages, or customized SLAs, Litewave offers AWS Marketplace Private Offers. Reach out to marketplace@litewave.ai .

For inquiries related to custom pricing or private contracts, reach out to sales@litewave.ai