Sold by: Litewave AI
Deployed on AWS
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.
Overview
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
Highlights
- AI-native GMP Intelligence Platform for pharma & API manufacturing, unifies paper/PDF records with MES, LIMS, and ERP data without rip-and-replace.
- Faster batch disposition with AI-assisted Batch Verification Reports-configurable GMP checks, review-by-exception, and traceable findings to focus QA on true risk.
- Designed for regulated manufacturing-supports 21 CFR Part 11 and EU Annex 11 expectations. Delivered as AWS Marketplace SaaS, with private cloud/on-prem options for data residency and factory isolation.
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Deployed on AWS
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Pricing
Pricing is based on the duration and terms of your contract with the vendor. This entitles you to a specified quantity of use for the contract duration. If you choose not to renew or replace your contract before it ends, access to these entitlements will expire.
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Dimension | Description | Cost/12 months |
|---|---|---|
Enterprise Plan | Annual subscription including 12,000,000 credits per contract year (reset annually), supported service limits (500 pages/day ingestion; 200 AI rule checks/day; 150 reports/day; 300 workflow runs/day; 60 min/day assistant), and up to 10 TB storage. Additional usage is available via Credit Packs. | $120,000.00 |
Dimensions summary
You buy one Enterprise Plan as an annual subscription billed per contract year. The plan includes 12,000,000 credits that reset each year. Credits fund activities like document ingestion, AI rule checks, report generation, workflow runs, and assistant time. The plan sets daily service limits for each activity and includes up to 10 TB of storage. When you need more than the included credits, you add capacity through Credit Packs. So pricing scales from one fixed annual base plus optional usage on top.
Top-of-mind questions for buyers
Credits are drawn by AI inference across the platform. Each page processed during ingestion, each batch validated by rule checks, each report generated, each workflow run, and each minute of assistant time consumes credits at posted rates. Every activity you run draws from your 12,000,000 annual pool.
Your jobs are not interrupted. The platform keeps running and bills the overage. You add capacity through Credit Packs at the per-credit rate. Credits reset at the start of each contract year, so unused credits do not carry over.
The daily limits and the credit pool are separate controls. Limits cap how much you can do each day: 500 pages ingested, 200 AI rule checks, 150 reports, 300 workflow runs, and 60 assistant minutes. Credits meter total annual usage. Both apply at the same time.
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Software as a Service (SaaS)
SaaS delivers cloud-based software applications directly to customers over the internet. You can access these applications through a subscription model. You will pay recurring monthly usage fees through your AWS bill, while AWS handles deployment and infrastructure management, ensuring scalability, reliability, and seamless integration with other AWS services.
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Litewave AI Support
Contact:
Support Hours (Standard):
Monday-Friday, 9:00 AM-5:00 PM PT (excluding US holidays)
Response Targets (Standard):
P1 (Production down / critical): Initial response within 4 business hours
P2 (Major impact): Initial response within 1 business day
P3 (Minor issue / question): Initial response within 2 business days
What's Included:
Onboarding assistance and configuration guidance
Troubleshooting and defect resolution
Usage questions (credits, workflows, reports, checks)
Release notes and planned maintenance notifications
24/7 & Custom SLAs (Enterprise):
24/7 support, dedicated channels, and custom SLAs are available via AWS Marketplace Private Offer.
AWS infrastructure support
AWS Support is a one-on-one, fast-response support channel that is staffed 24x7x365 with experienced and technical support engineers. The service helps customers of all sizes and technical abilities to successfully utilize the products and features provided by Amazon Web Services.
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