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Description
Clinisys is a global laboratory technology and informatics company that delivers advanced laboratory information management systems and laboratory information systems designed to modernize laboratory operations across healthcare, research, and public health environments. The company supports over 7,000 laboratory organizations worldwide and powers billions of lab tests annually through scalable and connected laboratory platforms. Clinisys solutions help laboratories streamline workflows, improve diagnostic accuracy, enhance disease surveillance, and enable more efficient data-driven decision-making across clinical, environmental, pharmaceutical, biotech, food, and research industries. The platform is built to integrate laboratory data from diverse systems and disciplines, helping organizations improve operational efficiency, testing scalability, and collaboration between laboratories and external healthcare or research systems. Clinisys also supports laboratories with industry-specific functionality tailored to more than 22 specialist research and testing disciplines across nine major industries. Its laboratory informatics ecosystem enables healthcare providers, scientists, and public health organizations to improve preventative care, therapeutic services, scientific discovery, and population health monitoring. The company emphasizes modern laboratory workflows, accessible data, automation, and scalable testing infrastructure that help laboratories process large sample volumes while maintaining accuracy and compliance. Clinisys solutions are widely used in clinical diagnostics, laboratory outreach programs, disease management, environmental testing, pharmaceutical research, and scientific innovation initiatives.
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.
API Access
Has API
API Access
Has API
Integrations
Microsoft SharePoint
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
25000.00
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Clinisys
Founded
1988
Country
United States
Website
www.clinisys.com
Vendor Details
Company Name
Xybion
Founded
1977
Country
United States
Website
www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/
Product 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
Product 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