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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Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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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
Grand Avenue Software Product Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Training Management
Risk Management
Root Cause Analysis
Calibration Management
Calibration Instructions
Calibration Schedules
Due Date Tracking
Compliance Management
Device History
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting
Change Management
Approval Workflow
Audit Trail
Release Management
Task Management
Training Management
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Tracking & Reporting
Complaint Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Issue Tracking
Quality Assurance Management
Routing
Case Management
Feedback Management
Forms Management
Self Service Portal
Social Media Monitoring
Survey Management
Document Version Control
Access Controls/Permissions
Approval Process Control
Audit Trail
Revision History
Archiving & Retention
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Version Comparison
Version Rollback
Preventive Maintenance
Maintenance Scheduling
Reminders
Condition Monitoring
Inspection Management
Mobile Access
Predictive Maintenance
Purchasing
To-Do List
Vendor Management
Work Order Management
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
ISO Standards Management
Vendor Management
Audit Management
Vendor Qualification Tracking
Contact Management
Customer Database
Self Service Portal
Supplier Master Data
Transaction History
Vendor Maintained Profiles
Vendor Managed Inventory
Vendor Performance Rating