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Average Ratings 4 Ratings

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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Microsoft SharePoint Yes 

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 

ELN

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 

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