Average Ratings 2 Ratings

Total
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Average Ratings 0 Ratings

Total
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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.

Description

Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

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 

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 

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 

Pricing Details

No price information available.
Free Trial No 
Free Version 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 

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 No 
Live Rep (24/7) Yes 
Online Support No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

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

Types of Training

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

Vendor Details

Company Name

eQuorum

Founded

1999

Country

United States

Website

www.equorum.com

Vendor Details

Company Name

Sierra Labs

Country

United States

Website

www.sierralabs.com/quality-management/

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 

Product Features

CAPA

Audit Management Yes 
CAPA Planning No 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing No 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management No 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback Yes 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management No 
Periodic Review 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 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control No 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Risk Management

Alerts/Notifications Yes 
Auditing No 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard No 
Exceptions Management Yes 
IT Risk Management Yes 
Internal Controls Management Yes 
Legal Risk Management No 
Mobile Access Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management No 
Response Management Yes 
Risk Assessment Yes 

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