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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

As a leading entity in laboratory informatics, ITDOSE Innopath has proficiently created and provided LIMS solutions on a global scale. Our informatics offerings are specifically designed to handle essential data within your organization across various laboratory sites, enhancing productivity and facilitating more effective knowledge sharing. We offer customizable off-the-shelf solutions catering to diverse functional laboratories, including those involved in research, development, quality control, biobanking, and environmental assessment, among others. ITDOSE Innopath is committed to transforming enterprise laboratory informatics by presenting a powerful blend of functionality, adaptability, and technology in a single platform. By assisting organizations in modeling their unique business workflows, we enable seamless integration with both instruments and business applications while ensuring compliance with government regulations, ultimately leading to increased productivity, lower operating costs, and enhanced overall quality. Furthermore, our solutions are continuously evolving to meet the changing needs of the industry, ensuring that our clients remain at the forefront of laboratory informatics advancements.

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 No 
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 Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

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

Customer Support

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

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
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

ITDOSE INFOSYSTEMS

Founded

2006

Country

India

Website

www.itdoseinfo.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

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 

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