Average Ratings 1 Rating
Average Ratings 0 Ratings
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
No
API Access
Has API
No
Integrations
Microsoft SharePoint
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
25000.00
Per user and server-based pricing
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
Yes
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
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
Yes
Document Management
Yes
Electronic Data Capture
Yes
Enrollment Management
No
HIPAA Compliant
Yes
Monitoring
Yes
Patient Database
Yes
Recruiting Management
No
Scheduling
Yes
Study Planning
No
LIMS
Audit Trail
Yes
Certificates of Analysis
Yes
Data Import / Export
Yes
Electronic Laboratory Notebook
Yes
Inventory Management
Yes
Lab Instrument Interface
Yes
Reporting & Statistics
Yes
Sample Tracking
Yes
Specification Management
No
Workflow Management
Yes
Medical Lab
Audit Trail
Yes
Data Analysis Auditing
Yes
Data Security
Yes
EMR Interface
Yes
Fax Management
Yes
Lab Instrument Interface
Yes
Multi-Location Printing
Yes
Online Instrumentation
Yes
Physician Test Panels
No
Procedure-Based Billing
Yes
Sample Tracking
Yes
Product Features
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
No
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
No
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
Yes
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
No
Data Governance
Access Control
Yes
Data Discovery
No
Data Mapping
No
Data Profiling
No
Deletion Management
No
Email Management
No
Policy Management
No
Process Management
Yes
Roles Management
No
Storage Management
No
Database Monitoring
Anomaly Detection
No
Autodiscovery
No
Capacity Planning
No
Dashboard
Yes
Dependency Tracking
No
Historical Trend Analysis
No
Multitenancy
No
Notifications / Alerts
Yes
Performance Monitoring
No
Permissions / Access Controls
Yes
Predictive Analytics
Yes
Prioritization
No
Query Analysis
No
Resource Optimization
No
Troubleshooting
No
Digital Signature
Audit Trail
Yes
Authentication
No
Auto Reminders
No
Customizable Templates
Yes
Document Analytics
No
Mobile Signature
No
Multi-Party Signing
No
Progress Tracking
No
Task Progress Tracking
No
LIMS
Audit Trail
No
Certificates of Analysis
No
Data Import / Export
No
Electronic Laboratory Notebook
No
Inventory Management
No
Lab Instrument Interface
No
Reporting & Statistics
No
Sample Tracking
No
Specification Management
No
Workflow Management
No
Quality Management
Audit Management
Yes
Complaint Management
No
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
Yes
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No