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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.

About

Food Safety Software enabling cost-effective transformation of food safety, NPD, customer complaints and supply chain transparency. Save time and complete consistent, auditable risk assessments of products & suppliers; our food safety software includes horizon scanning and VACCP/TACCP. Be audit-ready 24/7 and never receive an audit non-conformance, guaranteed. Transform specification management for raw materials, and finished products and answer product queries instantly. Automate supplier quality monitoring or internal non-conformance management with automated workflows to ensure prompt closure of non-conformances. Let our team manage the entire complaints process using market-leading software to save time, money and improve customer service. Deliver new product launches faster, better, together while ensuring that all safety, quality, legality and profitability requirements are met.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Medical Device Manufacturers that need an advanced Calibration Management solution

Audience

Food businesses, restaurants and stores interested in a solution to improve their operations

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

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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Reviews/Ratings

Overall 4.0 / 5
ease 3.0 / 5
features 4.0 / 5
design 4.0 / 5
support 5.0 / 5

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

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

Company Information

QADEX
Founded: 2006
United Kingdom
www.qadex.com

Alternatives

Alternatives

SBS Quality Management Software

SBS Quality Management Software

Sunday Business Systems
Intelex

Intelex

Intelex Technologies
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Radley Traceability

Radley Traceability

Radley Corporation
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

Complaint Management Features

Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Vendor Management Features

Audit Management
Contact Management
Customer Database
Self Service Portal
Supplier Master Data
Transaction History
Vendor Maintained Profiles
Vendor Managed Inventory
Vendor Performance Rating
Vendor Qualification Tracking

CAPA Features

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Calibration Management Features

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

Change Management Features

Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management

Document Version Control Features

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Preventive Maintenance Features

Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
To-Do List
Vendor Management
Work Order Management

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Supply Chain Management Features

Demand Planning
Electronic Data Interchange
Import / Export Management
Inventory Management
Order Fulfillment
Order Management
Sales & Operations Planning
Shipping Management
Supplier Management
Transportation Management
Warehouse Management

Integrations

No info available.

Integrations

No info available.
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