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Description
Qualcy Biomed QMS Software was designed for Bio-Medical businesses (including Biotech and Pharma) to manage QMS records in accordance with FDA and ISO13485 requirements. * Meets 21 CFR Part 820 requirements * Features include E-sign, audit trails, and compliance with 21 CFR part 11. This software manages Doc. Change control, complaints, audits CAPA, NC Records Training Records and many more.
Description
Virje meets the standards set forth by 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. If you're feeling daunted by the complexities of Part 11 software validation, rest assured that help is just a click away, no matter where you are or when you need it. By eliminating paperwork, cutting costs, and enhancing productivity through automation and unified collaboration, it becomes an ideal solution for small to medium-sized enterprises. Designed specifically for medical device quality management, this system is constructed to be adaptable to your unique workflows and processes, ensuring you don’t have to make any sacrifices. It features configurable change order approvals that can be tailored by employee role and document type, along with timely notifications sent to accountable team members throughout every phase of the change process. Users can assign material dispositions for specific documents, gain easy access to both released and archived versions, and quickly view the history of document changes. Additionally, it tracks where-used locations and the distribution of hard copies, while also providing reminders for periodic document reviews to ensure compliance and efficiency remain top priorities. This comprehensive approach not only streamlines quality management but also empowers organizations to maintain rigorous standards effortlessly.
API Access
Has API
No
API Access
Has API
No
Integrations
AWS Backup
Yes
AWS Cloud9
Yes
Gmail
Yes
Microsoft 365
Yes
Microsoft Azure
Yes
Microsoft Outlook
Yes
SAP Analytics Cloud
Yes
Integrations
AWS Backup
No
AWS Cloud9
No
Gmail
No
Microsoft 365
No
Microsoft Azure
No
Microsoft Outlook
No
SAP Analytics Cloud
No
Pricing Details
$799 per month
Free Trial
Yes
Free Version
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
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
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
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
Qualcy Systems
Founded
2014
Country
United States
Website
www.qualcy.com
Vendor Details
Company Name
Virje
Country
United States
Website
www.virje.com
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
Yes
Device History
No
Due Date Tracking
Yes
Gage Management
Yes
Label Printing
Yes
Measurement Readings
No
Multi-Station Management
No
Out-of-Tolerance Notification
No
Statistical Data Reporting
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
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
No
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No