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.

Pricing

Free Trial:
Free Trial available.

Integrations

API:
Yes, Grand Avenue Software offers API access
No integrations listed.

Ratings/Reviews

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ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
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Company Information

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

Videos and Screen Captures

Grand Avenue Software Screenshot 1
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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?
Q: What languages does Grand Avenue Software support in their product?
Q: What kind of support options does Grand Avenue Software offer?
Q: Does Grand Avenue Software have an API?
Q: What type of training does Grand Avenue Software provide?
Q: Does Grand Avenue Software offer a free trial?
Q: What pricing for support is available for Grand Avenue Software?

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