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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 Clinisys?

Clinisys is a comprehensive laboratory informatics and diagnostic technology company specializing in laboratory information management systems (LIMS), laboratory information systems (LIS), and connected data solutions for healthcare, public health, life sciences, environmental testing, and scientific research organizations worldwide. With more than 40 years of laboratory expertise and support for over 7,000 laboratory customers globally, Clinisys provides scalable technology platforms that process billions of laboratory tests each year while helping organizations modernize laboratory workflows and improve operational efficiency. The company delivers industry-specific laboratory solutions that support clinical diagnostics, disease surveillance, laboratory outreach, pharmaceutical development, biotech research, environmental monitoring, food and beverage testing, crop sciences, and water analysis across more than 22 specialist laboratory disciplines. Clinisys platforms are designed to integrate laboratory data from multiple systems and testing environments, enabling laboratories to improve accessibility, streamline workflows, automate processes, and deliver faster and more accurate decision-making. The company’s solutions support healthcare organizations in improving preventative, diagnostic, and therapeutic services while also helping public health agencies strengthen disease tracking, contact tracing, and case management capabilities at scale. Clinisys additionally empowers research scientists and laboratory professionals with data-driven insights that accelerate scientific discovery and improve understanding across life sciences and natural sciences research initiatives. The platform architecture emphasizes interoperability, workflow optimization, scalability, and advanced laboratory automation that allow organizations to efficiently manage growing testing demands and complex 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

Clinisys

Date Founded

1988

Company Location

United States

Company Website

www.clinisys.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

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

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

Medical Lab

Audit Trail
Data Analysis Auditing
Data Security
EMR Interface
Fax Management
Lab Instrument Interface
Multi-Location Printing
Online Instrumentation
Physician Test Panels
Procedure-Based Billing
Sample Tracking

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