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What is Virje?

Virje complies with the regulations outlined in 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. If you find the intricacies of Part 11 software validation overwhelming, you can find assistance readily available at your fingertips, regardless of your location or the time. By reducing reliance on paper, minimizing expenses, and boosting efficiency through automation and cohesive teamwork, it proves to be an excellent choice for small to medium-sized businesses. Specifically tailored for quality management in the medical device sector, this system is designed to be flexible, allowing you to adapt it to your particular workflows without needing to compromise. Its configurable change order approvals can be adjusted based on employee roles and document categories, with timely alerts sent to responsible team members at each step of the change process. Users can designate material dispositions for individual documents, effortlessly access both current and archived versions, and quickly review the history of document modifications. Moreover, it tracks the locations of use and the distribution of physical copies while providing reminders for regular document assessments, ensuring that compliance and efficiency are prioritized. This all-encompassing strategy not only enhances quality management processes but also enables organizations to uphold high standards with ease, creating a culture of continuous improvement and accountability.

What is SimplerQMS?

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

Media

Media

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

Microsoft 365
Microsoft Entra ID

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$13,750/year
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Virje

Company Location

United States

Company Website

www.virje.com

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Categories and Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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