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Description
Compliance Builder™, a real-time monitoring tool, is designed to enable 21 CFR Part 11 compliance. It provides data integrity across IT systems such file systems, laboratory and manufacturing instruments, as well as providing file system, database, laboratory, and manufacturing instrument data integrity. Compliance Builder allows you secure track all IT subsystems, including file systems, databases and laboratory equipment. It can be set up to monitor any file-based system, including file modifications and additions.
Description
QLIMS is an all-encompassing Laboratory Information Management System (LIMS) aimed at enhancing laboratory workflows across different sectors. As a genuine Software as a Service (SaaS) offering, QLIMS can be rapidly implemented, allowing laboratories to become functional in a matter of weeks rather than years. Its intuitive interface supports significant customization without requiring programming skills, empowering users to adjust screens, generate custom fields, and adapt workflows to meet specific requirements. The platform is equipped with integrated business intelligence dashboards that deliver up-to-date insights into management and operational metrics, featuring pre-set visualizations along with the option for users to create their own. QLIMS is designed to adhere to a variety of industry regulations, including 21 CFR Part 11/Annex 11 regarding auditing and electronic signatures, ISO 17025, and GAMP, while also safeguarding data security and privacy in accordance with HIPAA, GDPR, CAP, CLIA, and Privacy Shield standards. With its robust features and commitment to compliance, QLIMS stands out as a vital tool for laboratories aiming to optimize their operations and ensure regulatory adherence.
API Access
Has API
API Access
Has API
Pricing Details
25000.00
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Xybion
Founded
1977
Country
United States
Website
www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/
Vendor Details
Company Name
OnQ Software
Founded
1992
Country
Australia
Website
www.onqsoft.com.au/best-lims-qlims/
Product Features
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
Data Governance
Access Control
Data Discovery
Data Mapping
Data Profiling
Deletion Management
Email Management
Policy Management
Process Management
Roles Management
Storage Management
Database Monitoring
Anomaly Detection
Autodiscovery
Capacity Planning
Dashboard
Dependency Tracking
Historical Trend Analysis
Multitenancy
Notifications / Alerts
Performance Monitoring
Permissions / Access Controls
Predictive Analytics
Prioritization
Query Analysis
Resource Optimization
Troubleshooting
Digital Signature
Audit Trail
Authentication
Auto Reminders
Customizable Templates
Document Analytics
Mobile Signature
Multi-Party Signing
Progress Tracking
Task Progress Tracking
LIMS
Audit Trail
Certificates of Analysis
Data Import / Export
Electronic Laboratory Notebook
Inventory Management
Lab Instrument Interface
Reporting & Statistics
Sample Tracking
Specification Management
Workflow 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
Product Features
LIMS
Audit Trail
Certificates of Analysis
Data Import / Export
Electronic Laboratory Notebook
Inventory Management
Lab Instrument Interface
Reporting & Statistics
Sample Tracking
Specification Management
Workflow Management