Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Providing Quality Management Software is essential for managing compliance with various ISO standards, including ISO 9001, ISO 13485, ISO 17025, FDA, GMP, and BRC. This EQMS software is being utilized across a wide range of industries, each with distinct ISO requirements, all with the unified objective of enhancing product quality and maintaining superior standards. While some EQMS applications cater more effectively to large enterprises, others are tailored for small to medium-sized businesses, yet all share critical features that define the best quality management solutions available. Companies can integrate processes like CAPA (Corrective Action Preventative Action) within their EQMS software, and it's important to note that the implementation of these processes may vary significantly between organizations, even within the same industry. The flexibility to customize workflows, forms, and layouts based on the unique operations of a business is crucial for ensuring a seamless adoption of the system. Ultimately, this adaptability not only facilitates compliance but also fosters a culture of continual improvement across all levels of the organization.
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
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
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
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
No
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
Sercle
Country
United States
Website
www.serclesoftware.com/quality-management-software/
Vendor Details
Company Name
Virje
Country
United States
Website
www.virje.com
Product Features
Quality Management
Audit Management
Yes
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
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