LitewaveLitewave AI
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qmsWrapper4.7 out of 5 stars |
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Related Products
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Litewave:
About
Litewave is an AI quality review platform for regulated manufacturers across pharma, biotech, CDMO, medical device, dietary supplement, food, cosmetics, and CPG sectors. It reviews batch records, device history records (DHRs), certificates of analysis (CoAs), and supplier documents against specifications, approved supplier lists, and required tests. Each flagged discrepancy links to its source page and field, helping quality teams review exceptions and sign off while keeping records audit-ready for FDA, NSF, SQF, and customer audits. Litewave handles paper and handwritten records as well as digitized workflows, and works with existing MES, QMS, LIMS, and ERP systems. Structured data supports quality and manufacturing analytics across batches, sites, and suppliers. Deployment options include on-premises and customer-cloud environments. Use cases include batch record and DHR review, supplier CoA verification, paper-to-digital batch records, audit readiness, and quality analytics.
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qmsWrapper:
About
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance.
Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance.
Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.
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Litewave:
Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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qmsWrapper:
Platforms Supported
Windows
Supported
Mac
Supported
Linux
Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Litewave:
Audience
Quality, regulatory, and manufacturing teams at pharma, biotech, CDMO, medical device, dietary supplement, food, cosmetics, and CPG companies.
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qmsWrapper:
Audience
Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability
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Litewave:
Support
Phone Support
Not Supported
24/7 Live Support
Supported
Online
Not Supported
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qmsWrapper:
Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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Litewave:
API
Offers API
Not Supported
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qmsWrapper:
API
Offers API
Not Supported
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Litewave:
Screenshots and VideosNo images available
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qmsWrapper:
Screenshots and Videos |
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Litewave:
PricingEnterprise agreement pricing is scoped to workflows, sites, production lines and users, document and batch volumes, deployment model, support commitments, and validation documentation. Engagements can begin with a scoped evaluation using the customer's records before commitment.
Free Version
Not Supported
Free Trial
Supported
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qmsWrapper:
Pricing
€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Version
Not Supported
Free Trial
Not Supported
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Litewave:
Reviews/
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qmsWrapper:
Reviews/
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qmsWrapper:
Pros & Cons from Real UsersPros
Cons
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Litewave:
Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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qmsWrapper:
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Litewave:
Company InformationLitewave AI
Founded: 2024
United States
litewave.ai/
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qmsWrapper:
Company InformationqmsWrapper
Canada
www.qmswrapper.com
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Litewave:
AlternativesNo Alternatives
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qmsWrapper:
Alternatives |
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qmsWrapper:
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qmsWrapper:
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Litewave:
Categories |
qmsWrapper:
Categories |
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qmsWrapper:
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Not Supported
ISO Standards Management
Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Not Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Supported
Training Management
Supported
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Litewave:
Integrations
Jira
Not Supported
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Litewave:
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qmsWrapper:
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