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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

All-in-One LIMS, ELN, QMS, and DMS Platform Xybion LIMS is an all-inclusive Digital Laboratory system including LIMS, ELN, QMS, and DMS that creates optimized workflows for the unique business needs of all regulated laboratories including research, diagnostics, quality control, stability studies, and more. Xybion LIMS instills consistency, improves data quality, and supports regulatory compliance with a complete laboratory management solution that connects with your operating systems with powerful laboratory information management and analytics.

API Access

Has API No 

API Access

Has API Yes 

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

Schedule demo for pricing details.
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 Yes 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux Yes 
Chromebook Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
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

Xybion

Founded

1977

Country

United States

Website

www.xybion.com/digital-lab-management-system/

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

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management Yes 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation No 

ELN

Government

Budgeting & Forecasting No 
Code Enforcement No 
Compliance Management Yes 
Fixed Asset Management No 
Inventory Management Yes 
License Issuance No 
Permit Issuance No 
Purchasing & Receiving Yes 
Self Service Portal No 
Taxation & Assessment No 
Utility Billing No 
Work Order Management No 

Lab Inventory Management

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

LIMS

Audit Trail Yes 
Certificates of Analysis Yes 
Data Import / Export Yes 
Electronic Laboratory Notebook Yes 
Inventory Management Yes 
Lab Instrument Interface Yes 
Reporting & Statistics Yes 
Sample Tracking Yes 
Specification Management Yes 
Workflow Management Yes 

Manufacturing

Accounting Integration No 
ERP Yes 
MES No 
MRP No 
Maintenance Management No 
Purchase Order Management No 
Quality Management Yes 
Quotes/Estimates No 
Reporting/Analytics Yes 
Safety Management No 
Shipping Management No 

Medical Lab

Audit Trail Yes 
Data Analysis Auditing No 
Data Security Yes 
EMR Interface No 
Fax Management No 
Lab Instrument Interface Yes 
Multi-Location Printing No 
Online Instrumentation No 
Physician Test Panels No 
Procedure-Based Billing No 
Sample Tracking Yes 

Pharmacy

Automatic Refills No 
Barcode Generation Yes 
Claims Management Yes 
Compounding Yes 
E-Prescribing No 
Electronic Signature Yes 
Forms Management No 
Insurance Processing No 
Inventory Management No 
Multi-Store Management No 
Online Refills No 
Pill Database No 
Pill Imaging No 
Point of Sale (POS) No 
Prescription Processing No 
Rx Image Scanning No 
Signature Capture No 

Predictive Analytics

AI / Machine Learning No 
Benchmarking Yes 
Data Blending No 
Data Mining Yes 
Demand Forecasting Yes 
For Education No 
For Healthcare Yes 
Modeling & Simulation No 
Sentiment Analysis No 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management No 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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