Litewave

Litewave

Litewave AI
Grand Avenue Software Litewave

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Grand Avenue Software:

About

A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed.
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.
Grand Avenue Software:

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported
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
Grand Avenue Software:

Audience

Medical Device Manufacturers that need an advanced Calibration Management solution
Litewave:

Audience

Quality, regulatory, and manufacturing teams at pharma, biotech, CDMO, medical device, dietary supplement, food, cosmetics, and CPG companies.
Grand Avenue Software:

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported
Litewave:

Support

Phone Support Not Supported
24/7 Live Support Supported
Online Not Supported
Grand Avenue Software:

API

Offers API Supported
Litewave:

API

Offers API Not Supported
Grand Avenue Software:

Screenshots and Videos

Litewave:

Screenshots and Videos

No images available
Grand Avenue Software:

Pricing

No information available.
Free Version Not Supported
Free Trial Supported
Litewave:

Pricing

Enterprise 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
Grand Avenue Software:

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Litewave:

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software
Grand Avenue Software:

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported
Litewave:

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported
Grand Avenue Software:

Company Information

Grand Avenue Software
Founded: 2002
United States
www.grandavenue.com
Litewave:

Company Information

Litewave AI
Founded: 2024
United States
litewave.ai/
Grand Avenue Software:

Alternatives

Greenlight Guru

Greenlight Guru

4.4 out of 5 stars
Litewave:

Alternatives

No Alternatives
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5.0 out of 5 stars
Grand Avenue Software:
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Grand Avenue Software:
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Grand Avenue Software:
Sierra QMS

Sierra QMS

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Litewave:
Grand Avenue Software:

Categories

Litewave:

Categories

Quality Management Supported
Grand Avenue Software:

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 Supported
ISO Standards Management Not Supported
Maintenance Management 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 Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Not Supported
Root Cause Analysis Not Supported
Training Management Supported

Calibration Management Features

Calibration Instructions Supported
Calibration Schedules Supported
Compliance Management Not Supported
Device History Not Supported
Due Date Tracking Supported
Gage Management Not Supported
Label Printing Not Supported
Measurement Readings Not Supported
Multi-Station Management Not Supported
Out-of-Tolerance Notification Not Supported
Statistical Data Reporting Not Supported

Change Management Features

Approval Workflow Supported
Audit Trail Supported
Automated Notifications Not Supported
Change Calendar Not Supported
Change Planning Not Supported
Compliance Management Not Supported
Prioritization Not Supported
Release Management Supported
Task Management Supported
Tracking & Reporting Not Supported
Training Management Supported

Complaint Management Features

Case Management Not Supported
Complaint Classification Supported
Corrective Actions (CAPA) Supported
Customer Complaint Tracking Supported
Feedback Management Not Supported
Forms Management Not Supported
Issue Tracking Supported
Quality Assurance Management Supported
Routing Supported
Self Service Portal Not Supported
Social Media Monitoring Not Supported
Survey Management Not Supported

Document Version Control Features

Access Controls/Permissions Supported
Approval Process Control Supported
Archiving & Retention Not Supported
Audit Trail Supported
Commenting / Notes Not Supported
Document Check-in / Check-out Not Supported
For Engineering Documents Not Supported
Revision History Supported
Version Comparison Not Supported
Version Rollback Not Supported

Preventive Maintenance Features

Condition Monitoring Not Supported
Inspection Management Not Supported
Maintenance Scheduling Supported
Mobile Access Not Supported
Predictive Maintenance Not Supported
Purchasing Not Supported
Reminders Supported
To-Do List Not Supported
Vendor Management Not Supported
Work Order Management Not Supported

Vendor Management Features

Audit Management Supported
Contact Management Not Supported
Customer Database Not Supported
Self Service Portal Not Supported
Supplier Master Data Not Supported
Transaction History Not Supported
Vendor Maintained Profiles Not Supported
Vendor Managed Inventory Not Supported
Vendor Performance Rating Not Supported
Vendor Qualification Tracking Supported
Grand Avenue Software:

Integrations

No info available.
Litewave:

Integrations

No info available.
Grand Avenue Software:
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Litewave:
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