Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Transform your inefficient, paper-heavy management system into a streamlined, cost-effective digital solution. The Documentation module enables you to efficiently oversee the review, modification, approval, distribution, and accessibility of all your documents. Additionally, it allows you to track and manage issues arising from defects in your organization's products, services, or systems. You can categorize how your data will be reported by grouping problems based on your specific criteria such as regions, services, product categories, processes, and associated risks. Moreover, the software facilitates the creation of schedules for both Internal and supplier audits, ensuring responsibilities are assigned and linking findings to the corresponding planned audits. You can also establish a rolling schedule for calibration and maintenance tasks according to your specified frequency. All task records, along with any related attachments, are securely stored within the software. Furthermore, this module is offered at no additional cost, enhancing your operational efficiency without straining your budget.
Description
A web-based software suite for medical device companies that automates their processes and simplifies regulatory compliance. Modules include Audit Management, CAPA and Complaint Handling. Designed from the start for ISO 13485 compliance and 21 CFR Part 11 compliance.
API Access
Has API
No
API Access
Has API
Yes
Integrations
No details available.
Integrations
No details available.
Pricing Details
$255 per month
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
AutoSHEQ Solutions
Founded
1997
Country
South Africa
Website
www.autosheq.com
Vendor Details
Company Name
Grand Avenue Software
Founded
2002
Country
United States
Website
www.grandavenue.com
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
Yes
Risk Management
No
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
No
Device History
No
Due Date Tracking
Yes
Gage Management
No
Label Printing
No
Measurement Readings
No
Multi-Station Management
No
Out-of-Tolerance Notification
No
Statistical Data Reporting
No
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
No
Root Cause Analysis
No
Training Management
Yes
Change Management
Approval Workflow
Yes
Audit Trail
Yes
Automated Notifications
No
Change Calendar
No
Change Planning
No
Compliance Management
No
Prioritization
No
Release Management
Yes
Task Management
Yes
Tracking & Reporting
No
Training Management
Yes
Complaint Management
Case Management
No
Complaint Classification
Yes
Corrective Actions (CAPA)
Yes
Customer Complaint Tracking
Yes
Feedback Management
No
Forms Management
No
Issue Tracking
Yes
Quality Assurance Management
Yes
Routing
Yes
Self Service Portal
No
Social Media Monitoring
No
Survey Management
No
Document Version Control
Access Controls/Permissions
Yes
Approval Process Control
Yes
Archiving & Retention
No
Audit Trail
Yes
Commenting / Notes
No
Document Check-in / Check-out
No
For Engineering Documents
No
Revision History
Yes
Version Comparison
No
Version Rollback
No
Preventive Maintenance
Condition Monitoring
No
Inspection Management
No
Maintenance Scheduling
Yes
Mobile Access
No
Predictive Maintenance
No
Purchasing
No
Reminders
Yes
To-Do List
No
Vendor Management
No
Work Order Management
No
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Vendor Management
Audit Management
Yes
Contact Management
No
Customer Database
No
Self Service Portal
No
Supplier Master Data
No
Transaction History
No
Vendor Maintained Profiles
No
Vendor Managed Inventory
No
Vendor Performance Rating
No
Vendor Qualification Tracking
Yes