Average Ratings 0 Ratings
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
IMSXpress ISO 9001 serves as comprehensive software for document control and quality system management. Users can install the IMSXpress client on individual PCs or on a Windows server, which allows for distribution to users through remote desktop services as a remote application. The underlying database operates on MS SQL and can be set up on any version from MS SQL Server 2014 onward, with access to the IMSXpress application available across various network types. Options for remote access include setting up your own network, utilizing the cloud-based hosting service, or opting for an online subscription package. The system features a fully automated training module that includes self-training, integrated document training, and job descriptions, among other resources. It is designed to facilitate changes in documents, engineering, and processes, enabling users to create fillable PDF templates, populate them with data, and generate records effortlessly. Additionally, IMSXpress is useful for scheduling maintenance tasks, managing spare parts inventory, and overseeing complaints, non-conformities, risk management, and audit findings. This versatility ensures that organizations can maintain high standards in quality management while streamlining their operational processes.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Microsoft Excel
No
SQL Server
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
$160 per month
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
Yes
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
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
Yes
Vendor Details
Company Name
Grand Avenue Software
Founded
2002
Country
United States
Website
www.grandavenue.com
Vendor Details
Company Name
IMSXpress
Founded
1992
Country
Canada
Website
www.imsxp.com/00Home/IsoXpHome.aspx
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