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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

Microsoft SharePoint

API Availability

Has API

API Availability

Has API

Pricing Information

25000.00
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

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

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

Categories and Features

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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