Average Ratings 0 Ratings
Average Ratings 4 Ratings
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
LIMSey is a cloud-based laboratory information management system (LIMS) for engineering and manufacturing test labs. Most LIMS platforms target clinical diagnostics, pharmaceutical research, or genomics. LIMSey is built for physical test labs inside manufacturers: appliance, automotive, packaging, aerospace, and industrial equipment.
Capabilities include a test request intake portal, job and task tracking on configurable kanban boards, sample tracking with chain of custody and barcode labeling, automated resource scheduling, equipment and calibration management, training records, template-driven test reports in PDF or Excel, and dashboards for turnaround time, throughput, and equipment utilization.
The AutoScheduler works from capability matrices for personnel and instruments, task durations, and job priorities. It assigns the soonest qualified resource to each task and recalculates the schedule when priorities, durations, or availability change. Calibration records support reverse traceability, so when an instrument fails its as-found check every affected job is identifiable immediately.
Architecture: multi-tenant SaaS on AWS in US regions, browser-based with no client install or plugins, and multi-availability-zone database replication with daily automated backups.
Integrations: REST API, single sign-on, CSV and Excel import and export, BI tool read access, and automated email notifications.
Security: encryption in transit and at rest, role-based permissions with per-module granularity, and a complete audit trail recording user, timestamp, and prior value for every change. Supports ISO 17025 requirements including document control, corrective action, and equipment traceability. Hosted in ISO 27001 certified data
API Access
Has API
No
API Access
Has API
No
Integrations
Microsoft SharePoint
No
Pricing Details
25000.00
Per user and server-based pricing
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
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)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Xybion
Founded
1977
Country
United States
Website
www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/
Vendor Details
Company Name
LIMSey
Founded
2016
Country
United States
Website
www.limsey.com
Product Features
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
No
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
No
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
Yes
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
No
Data Governance
Access Control
Yes
Data Discovery
No
Data Mapping
No
Data Profiling
No
Deletion Management
No
Email Management
No
Policy Management
No
Process Management
Yes
Roles Management
No
Storage Management
No
Database Monitoring
Anomaly Detection
No
Autodiscovery
No
Capacity Planning
No
Dashboard
Yes
Dependency Tracking
No
Historical Trend Analysis
No
Multitenancy
No
Notifications / Alerts
Yes
Performance Monitoring
No
Permissions / Access Controls
Yes
Predictive Analytics
Yes
Prioritization
No
Query Analysis
No
Resource Optimization
No
Troubleshooting
No
Digital Signature
Audit Trail
Yes
Authentication
No
Auto Reminders
No
Customizable Templates
Yes
Document Analytics
No
Mobile Signature
No
Multi-Party Signing
No
Progress Tracking
No
Task Progress Tracking
No
LIMS
Audit Trail
No
Certificates of Analysis
No
Data Import / Export
No
Electronic Laboratory Notebook
No
Inventory Management
No
Lab Instrument Interface
No
Reporting & Statistics
No
Sample Tracking
No
Specification Management
No
Workflow Management
No
Quality Management
Audit Management
Yes
Complaint Management
No
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
Yes
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No
Product Features
Calibration Management
Calibration Instructions
Yes
Calibration Schedules
Yes
Compliance Management
Yes
Device History
Yes
Due Date Tracking
Yes
Gage Management
No
Label Printing
Yes
Measurement Readings
Yes
Multi-Station Management
No
Out-of-Tolerance Notification
No
Statistical Data Reporting
No
Lab Inventory Management
Barcode Scanning
No
Expiration Date Management
No
Purchasing
No
Reorder Management
No
Sample Management
Yes
Supply Management
Yes
Usage Tracking
Yes
Vendor Management
No
LIMS
Audit Trail
Yes
Certificates of Analysis
Yes
Data Import / Export
Yes
Electronic Laboratory Notebook
Yes
Inventory Management
No
Lab Instrument Interface
No
Reporting & Statistics
Yes
Sample Tracking
Yes
Specification Management
Yes
Workflow Management
Yes