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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 Clarity LIMS?

Clarity LIMS is an advanced laboratory information management system specifically designed for genomics labs, enabling efficient sample tracking and workflow optimization to boost laboratory productivity. It goes beyond simple sample monitoring, serving as an essential digital backbone for lab operations that includes comprehensive management of data, specimens, personnel, equipment, and inventory. By automating and standardizing procedures, Clarity LIMS considerably shortens process durations while decreasing the chances of human mistakes. This adaptable platform is capable of evolving alongside the lab's requirements, seamlessly incorporating new technologies and methods. Furthermore, it accelerates laboratory processes through user-friendly implementation and offers preconfigured workflows for Illumina sample and library preparation, along with quality control features that detect substandard samples. The system also prioritizes regulatory compliance, equipped with functionalities such as electronic signatures, audit trails, reagent tracking, and strong privacy and security protocols. Additionally, Clarity LIMS enhances accuracy and reliability by integrating automation with built-in business logic and error-checking systems, ensuring dependable outcomes while also providing analytical insights that can contribute to research advancements. Overall, this comprehensive solution supports laboratories in achieving their operational goals with greater efficiency and effectiveness.

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

Illumina

Company Location

United States

Company Website

www.illumina.com/products/by-type/informatics-products/clarity-lims.html

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

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

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