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Average Ratings 0 Ratings
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.
Description
Assess compliance by tracking actions such as Non-Conformance Reports, incidents, near misses, and management review actions, as effective Non-Conformance Management is crucial for fostering continuous improvement. With ACTION Manager, you can revolutionize your business operations by overseeing and organizing all documentation from a single, centralized platform, allowing for seamless integration across one system, one company, and multiple sites and countries. DOC Manager facilitates the management of your company objectives by employing the SMART criteria, ensuring that goals are Specific, Measurable, Achievable, Relevant, and Time-Bound. With Objective Manager, you can effectively handle your employees' training needs, providing a straightforward method for tracking and managing training records and competency evaluations. Training Manager empowers you to take charge of your internal audit life cycle, enhancing audit efficiency throughout your organization. The Management of Change application standardizes your change management process, guiding you from initiation and evaluation all the way to implementation and follow-up, ensuring a structured approach to organizational change. By integrating these tools, your organization can realize improved compliance and operational efficiency across all departments.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Grand Avenue Software
Founded
2002
Country
United States
Website
www.grandavenue.com
Vendor Details
Company Name
ISO Software
Country
South Africa
Website
www.iso-office.co.za
Product Features
Calibration Management
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
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Change Management
Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management
Complaint Management
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
Document Version Control
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
Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
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
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Vendor Management
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
Product Features
Project Management
Agile Methodologies
Budget Management
Client Portal
Collaboration Tools
Cost-to-Completion Tracking
Customizable Templates
Gantt Charts
Idea Management
Kanban Board
Milestone Tracking
Portfolio Management
Resource Management
Time & Expense Tracking
Traditional Methodologies