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What is Compliance Builder?

Compliance Builderâ„¢ is a monitoring solution that operates in real time to ensure adherence to 21 CFR Part 11 regulations. This tool guarantees data integrity throughout various IT infrastructures, encompassing file systems, laboratory devices, and manufacturing instruments, while also ensuring the integrity of data from those sources. With Compliance Builder, you can safely oversee all IT subsystems, which include not only file systems and databases but also laboratory apparatus. The system can be configured to track any file-based platform, monitoring changes and additions to files effectively. Furthermore, its robust capabilities provide users with comprehensive oversight of their compliance landscape.

What is BtB Software?

BtB Software presents a specialized Laboratory Information Management System (LIMS) designed for both public health organizations and private clinical laboratories, equipped with strong security measures and comprehensive change tracking capabilities. This innovative platform is offered through the cloud on Azure, as well as on local SQL systems or even a standalone computer utilizing the free SQL Express version. Recently, our Dairy Laboratory Software has been upgraded with a new Report Generator added to its Search Module, empowering users to fully customize outputs, which can be saved under personalized names. Furthermore, BtB Software has achieved integration with the CalRedie interface for the management of Reportable Diseases, in compliance with California Title 17 section 2505, which includes data extraction, formatting according to HL72.5.1 standards, and efficient packaging via our Sweeper Interface for subsequent transmission to CalRedie using SOAP protocols. In addition, the software facilitates data exports to the CDC in required formats and supports local system exports using CSV files. The platform also boasts a thorough search and lookup functionality, while allowing for the monitoring of various human and animal interactions, thereby maintaining a high level of security and meticulous change tracking across the system. With these comprehensive features, users can proficiently manage laboratory data and ensure compliance with all relevant regulatory standards, ultimately streamlining laboratory operations.

Media

Media

Integrations Supported

Microsoft SharePoint

Integrations Supported

API Availability

API Availability

Pricing Information

25000.00
Per user and server-based pricing
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Windows

Supported Platforms

Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

24 Hour Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

Xybion

Date Founded

1977

Company Location

United States

Company Website

www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/

Company Facts

Organization Name

BtB Software

Date Founded

1983

Company Location

United States

Company Website

www.btbsoftware.com

Categories and Features

Compliance

Audit Management
Compliance Tracking
FDA Compliance
Risk Management
Sarbanes-Oxley Compliance
Version Control

Data Governance

Access Control
Process Management

Database Monitoring

Dashboard
Notifications / Alerts
Permissions / Access Controls
Predictive Analytics

Digital Signature

Audit Trail
Customizable Templates

IT Risk Management

Not specified

LIMS

Not specified

Quality Management

Audit Management
Compliance Management
Document Control

Categories and Features

LIMS

Not specified

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