Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
GxPLABS specializes in delivering a wide range of digital software solutions designed to support industries with stringent regulatory and quality requirements. Their product portfolio covers SOP and document management, learning management, electronic lab notebooks, lab information systems, quality management systems, and other specialized modules like CAPA, audit, risk, and calibration management. Built on a low code and AI-powered platform, GxPLABS ensures platform independence and device compatibility for flexible implementation. The solutions are fully compliant with major industry regulations including 21 CFR Part 11, Annex 11, ISO 9001, and ISO 27001. With over a decade of experience and a client base spanning 10+ countries, GxPLABS offers expert support and customizable options tailored to complex business challenges. Their offerings also include paperless validation, electronic batch manufacturing records, and case processing systems, enabling digitization and automation. Companies can leverage GxPLABS to streamline operations, enhance compliance, and improve data integrity. The company emphasizes flexible pricing and unique technological approaches to meet diverse client needs.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Microsoft SharePoint
No
Pricing Details
25000.00
Per user and server-based pricing
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
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
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Xybion
Founded
1977
Country
United States
Website
www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/
Vendor Details
Company Name
GxPLABS
Founded
2018
Country
India
Website
www.gxplabs.com
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
Product Features
CAPA
Audit Management
No
CAPA Planning
No
Change Management
No
Complaint Management
No
Incident Management
No
Nonconformance Tracking
No
Quality Control
No
Risk Management
No
Root Cause Analysis
No
Training Management
No
Learning Management Systems (LMS)
Academic / Education
No
Asynchronous Learning
No
Blended Learning
No
Built-In Course Authoring
No
Corporate / Business
No
Customizable
No
Gamification
No
Learner Portal
No
Mobile Learning
No
Open Source
No
SCORM Compliance
No
Synchronous Learning
No
Video Conferencing
No
eCommerce
No
eLearning Companies
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
No
Complaint Management
No
Compliance Management
No
Corrective and Preventive Actions (CAPA)
No
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
No