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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 CIMCON EUC Change Management?

The use of spreadsheets, models, Access databases, and a variety of End User Computing (EUC) applications is increasing significantly. While these tools can undergo validation after their development, any alterations made to EUCs can introduce errors and create serious risks for your organization. EUC Insight Change Management provides ongoing monitoring of high-risk EUCs, issuing alerts for critical changes and deploying flexible controls that effectively reduce risk. Users can compare files and examine modifications side by side for spreadsheets, macro code, and Access databases, facilitating a clearer understanding of changes. The sophisticated audit trail can focus on specific areas or cells, allowing for the identification of trends or specific alterations that may lead to inaccuracies. Additionally, EUC policies often require certain controls to be implemented. By utilizing EUC Change Management, you benefit from automated versioning, improved security, and comprehensive documentation, along with reporting features that enable you to customize your processes to fulfill distinct requirements. This all-encompassing strategy not only helps organizations stay compliant but also boosts their operational efficiency, ultimately leading to better decision-making and reduced risks associated with EUC applications. As organizations increasingly rely on these tools, maintaining rigorous oversight becomes essential for sustained success.

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

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online 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

CIMCON Software

Date Founded

1988

Company Location

United States

Company Website

www.cimcon.com/products/euc-insight-change-management

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

IT Risk Management

Not specified

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