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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.

Description

Sapio LIMS is an advanced laboratory information management system offering a unified no-code/low-code solution that streamlines laboratory workflows. Built on the Sapio Platform, which integrates LIMS, Electronic Lab Notebooks (ELN), and Scientific Data Management Systems (SDMS), it provides purpose-built solutions for scientific research and discovery, manufacturing, and clinical diagnostics. Sapio LIMS helps to optimize laboratory operations, seamlessly integrating with lab instrumentation and existing IT infrastructure. Through its robust, scalable architecture, Sapio LIMS enhances operational efficiency and ensures compliance with GxP standards such as GMP and GLP. Solutions are available for Life Sciences R&D, Clinical Diagnostics, Lab Operations and Analytics and Enterprise Data Management.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft Office 2024
Microsoft SharePoint
Sapio Sciences

Integrations

Microsoft Office 2024
Microsoft SharePoint
Sapio Sciences

Pricing Details

25000.00
Free Trial
Free Version

Pricing Details

No price information available.
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

Xybion

Founded

1977

Country

United States

Website

www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/

Vendor Details

Company Name

Sapio Sciences

Founded

2004

Country

United States

Website

www.sapiosciences.com

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

Product Features

ELN

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

Scientific Data Management System (SDMS)

Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows

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