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Average Ratings 2 Ratings

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support

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

ImageSite and Engine-Box (our Cloud-based SaaS version of ImageSite) are JAVA-less, comprehensive, yet affordable engineering document management solutions for scanned and native digital documents. There is no software to deploy to client computers or mobile apps to download as it is built in HTML5. Our system provides a powerful security, file storage and organization, and version control capabilities all from a central distribution point. Installation is simple and normally completed in a just a few days. Once installed, users can start using the system with very little training needed, recognizing all the benefits immediately.

API Access

Has API Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

AWS Identity and Access Management (IAM) No 
AutoCAD No 
Google No 
Inventor No 
Microsoft 365 No 
Microsoft Azure No 
Microsoft Outlook No 
Microsoft SharePoint No 
Okta No 
OneLogin No 
Revit No 
SOLIDWORKS No 

Integrations

AWS Identity and Access Management (IAM) Yes 
AutoCAD Yes 
Google Yes 
Inventor Yes 
Microsoft 365 Yes 
Microsoft Azure Yes 
Microsoft Outlook Yes 
Microsoft SharePoint Yes 
Okta Yes 
OneLogin Yes 
Revit Yes 
SOLIDWORKS Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

Call for Pricing for onpremise
Available as a SaaS Solution with subscription pricing. Contact us to learn more.
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 Yes 
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 No 
Live Rep (24/7) Yes 
Online Support No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs No 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Grand Avenue Software

Founded

2002

Country

United States

Website

www.grandavenue.com

Vendor Details

Company Name

eQuorum

Founded

1999

Country

United States

Website

www.equorum.com

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 

Product Features

Document Management

Access Controls Yes 
Archiving & Retention Yes 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture Yes 
Document Conversion Yes 
Document Delivery No 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management Yes 
File Recovery Yes 
File Type Conversion Yes 
Forms Management Yes 
Full Text Search Yes 
Offline Access Yes 
Optical Character Recognition Yes 
Print Management Yes 
Version Control Yes 

Document Version Control

Access Controls/Permissions Yes 
Approval Process Control Yes 
Archiving & Retention Yes 
Audit Trail Yes 
Commenting / Notes Yes 
Document Check-in / Check-out Yes 
For Engineering Documents Yes 
Revision History Yes 
Version Comparison Yes 
Version Rollback Yes 

Product Data Management

Bill of Material Management No 
Document Management Yes 
Formula Management No 
Product Analytics No 
Product Lifecycle Management Yes 
Testing Management No 
Version Control Yes 

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