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Average Ratings 4 Ratings

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ease
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support

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft SharePoint

Integrations

Microsoft SharePoint

Pricing Details

25000.00
Per user and server-based pricing
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

LIMSey

Founded

2016

Country

United States

Website

www.limsey.com

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

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

ELN

Lab Inventory Management

Barcode Scanning
Expiration Date Management
Purchasing
Reorder Management
Sample Management
Supply Management
Usage Tracking
Vendor Management

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

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