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What is Qualis LIMS?

Qualis LIMS serves as a robust laboratory information management system tailored for enterprises, finding applications across multiple sectors, including pharmaceuticals, life sciences, contract research, clinical trials, and testing of analytical and commercial samples. With its suite of integrated modules, this system streamlines laboratory operations, allowing institutions to automate processes and eliminate paper usage, all while maintaining adherence to both regulatory standards and industry norms. As a catalyst for digital transformation in laboratories, Qualis LIMS offers several key functionalities: • Streamlined management, storage, and aliquoting of samples. • Comprehensive record-keeping of test results and experimental data, along with the organization of tests, projects, samples, instruments, and inventory within a secure centralized database. • Assurance of compliance with critical data integrity and regulatory standards, including GxP, ISO17025, 21 CFR Part 11, and EudraLex Annex 11, without sacrificing quality or reliability. Furthermore, the system enhances laboratory efficiency by facilitating real-time data access and collaboration, ultimately leading to improved decision-making and operational outcomes.

What is Compliance Builder?

Compliance Builderâ„¢ is a monitoring solution that operates in real time to ensure adherence to 21 CFR Part 11 regulations. This tool guarantees data integrity throughout various IT infrastructures, encompassing file systems, laboratory devices, and manufacturing instruments, while also ensuring the integrity of data from those sources. With Compliance Builder, you can safely oversee all IT subsystems, which include not only file systems and databases but also laboratory apparatus. The system can be configured to track any file-based platform, monitoring changes and additions to files effectively. Furthermore, its robust capabilities provide users with comprehensive oversight of their compliance landscape.

Media

Media

Integrations Supported

Logilab ELN
Logilab SDMS

Integrations Supported

Microsoft SharePoint

API Availability

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

25000.00
Per user and server-based pricing
Free Trial Offered?

Supported Platforms

SaaS
Windows

Supported Platforms

SaaS
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Agaram Technologies

Date Founded

1998

Company Location

Chennai, India

Company Website

www.agaramtech.com/product/qualis-lims/

Company Facts

Organization Name

Xybion

Date Founded

1977

Company Location

United States

Company Website

www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/

Categories and Features

Lab Automation

Not specified

LIMS

Audit Trail
Certificates of Analysis
Electronic Laboratory Notebook
Inventory Management
Lab Instrument Interface
Sample Tracking
Specification Management
Workflow Management

Medical Lab

Audit Trail
Lab Instrument Interface
Procedure-Based Billing

Categories and Features

Compliance

Audit Management
Compliance Tracking
FDA Compliance
Risk Management
Sarbanes-Oxley Compliance
Version Control

Data Governance

Access Control
Process Management

Database Monitoring

Dashboard
Notifications / Alerts
Permissions / Access Controls
Predictive Analytics

Digital Signature

Audit Trail
Customizable Templates

IT Risk Management

Not specified

LIMS

Not specified

Quality Management

Audit Management
Compliance Management
Document Control

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