Audience
Medical Device Manufacturers that need an advanced Calibration Management solution
About Grand Avenue Software
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.
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Pricing
Free Trial:
Free Trial available.
Integrations
API:
Yes, Grand Avenue Software offers API access
No integrations listed.
Company Information
Grand Avenue Software
Founded: 2002
United States
www.grandavenue.com
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Product Details
Platforms Supported
Cloud
Training
Documentation
Live Online
Webinars
Support
Phone Support
Online
Grand Avenue Software Frequently Asked Questions
Q: What kinds of users and organization types does Grand Avenue Software work with?
Grand Avenue Software works with these users and organization types: Mid Size Business, Small Business, Enterprise, Freelance, Nonprofit, Government, and Startup.
Q: What languages does Grand Avenue Software support in their product?
Grand Avenue Software supports these languages: English.
Q: What kind of support options does Grand Avenue Software offer?
Grand Avenue Software offers support via phone support and online.
Q: Does Grand Avenue Software have an API?
Yes, Grand Avenue Software has an API.
Q: What type of training does Grand Avenue Software provide?
Grand Avenue Software provides training in the form of documentation, live online, and webinars.
Q: Does Grand Avenue Software offer a free trial?
Yes, Grand Avenue Software offers a free trial.
Q: What pricing for support is available for Grand Avenue Software?
Grand Avenue Software offers support included with purchase.
Grand Avenue Software Product Features
CAPA
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Training Management
Supported
Risk Management
Not Supported
Root Cause Analysis
Not Supported
Calibration Management
Calibration Instructions
Supported
Calibration Schedules
Supported
Due Date Tracking
Supported
Compliance Management
Not Supported
Device History
Not 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
Approval Workflow
Supported
Audit Trail
Supported
Release Management
Supported
Task Management
Supported
Training Management
Supported
Automated Notifications
Not Supported
Change Calendar
Not Supported
Change Planning
Not Supported
Compliance Management
Not Supported
Prioritization
Not Supported
Tracking & Reporting
Not Supported
Complaint Management
Complaint Classification
Supported
Corrective Actions (CAPA)
Supported
Customer Complaint Tracking
Supported
Issue Tracking
Supported
Quality Assurance Management
Supported
Routing
Supported
Case Management
Not Supported
Feedback Management
Not Supported
Forms Management
Not Supported
Self Service Portal
Not Supported
Social Media Monitoring
Not Supported
Survey Management
Not Supported
Document Version Control
Access Controls/Permissions
Supported
Approval Process Control
Supported
Audit Trail
Supported
Revision History
Supported
Archiving & Retention
Not Supported
Commenting / Notes
Not Supported
Document Check-in / Check-out
Not Supported
For Engineering Documents
Not Supported
Version Comparison
Not Supported
Version Rollback
Not Supported
Preventive Maintenance
Maintenance Scheduling
Supported
Reminders
Supported
Condition Monitoring
Not Supported
Inspection Management
Not Supported
Mobile Access
Not Supported
Predictive Maintenance
Not Supported
Purchasing
Not Supported
To-Do List
Not Supported
Vendor Management
Not Supported
Work Order Management
Not Supported
Quality Management
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
ISO Standards Management
Not Supported
Vendor Management
Audit Management
Supported
Vendor Qualification Tracking
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
