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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 Total Lean Management (TLM) Software?

TLM QMS Software is an advanced and reliable platform for quality, risk, and material management that meets validation and 21 CFR Part 11 compliance standards. This innovative, comprehensive quality management system is designed for customization, allowing seamless integration with online CRM solutions, QuickBooks, or ERP systems. Total Lean Management (TLM) QMS Software aims to provide an economical and highly cohesive environment that is adaptable and continuously evolving, enabling the incorporation of specialized systems as necessary to develop a digital business ecosystem tailored to your organization’s workflow requirements. This flexibility ensures that the software can grow alongside your business, responding effectively to changing needs over time.

Media

Media

Integrations Supported

Epicor Advanced MES
Epicor Kinetic
Microsoft Dynamics 365
Microsoft Outlook
QuickBooks Enterprise
Zoho CRM Plus

Integrations Supported

Epicor Advanced MES
Epicor Kinetic
Microsoft Dynamics 365
Microsoft Outlook
QuickBooks Enterprise
Zoho CRM Plus

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$45/user/month
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

Lean & Mean Business Systems

Date Founded

2001

Company Location

United States

Company Website

www.tlm-software.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

Calibration Management

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

CAPA

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

Document Control

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

Manufacturing

Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management

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

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

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