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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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Microsoft SharePoint No 

Integrations

Microsoft SharePoint Yes 

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 

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