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What is GxPLABS?

GxPLABS is a leading provider of comprehensive digital transformation solutions designed for regulated industries, offering a broad suite of software products to streamline business processes and ensure compliance. Their extensive catalog includes SOP management, document management systems, learning management, laboratory information management systems (LIMS), electronic lab notebooks (ELN), quality management systems (QMS), and a variety of specialized applications such as CAPA, audit management, risk management, supplier management, and electronic batch manufacturing records. The platform is built on a low code, AI-enabled framework that supports platform and device independence, allowing seamless integration and flexibility across diverse environments. All solutions adhere to critical industry standards like 21 CFR Part 11, Annex 11, ISO 9001, and ISO 27001, providing clients with robust regulatory compliance. With over 10 years of industry experience, GxPLABS serves customers in more than 10 countries, backed by a team of top industry specialists and strong client support. Their offerings include advanced features like paperless validation, cleaning validation, deviation management, electronic logbooks, and forms control software, facilitating full digitization of complex workflows. The company also provides custom software development capabilities for clients with unique requirements. GxPLABS emphasizes innovation through unique technologies and flexible pricing models to accommodate different business sizes and needs. Their platform enables organizations to reduce operational risks, improve data quality, and enhance efficiency. Overall, GxPLABS stands out as a trusted partner for businesses seeking scalable, compliant, and customizable digital solutions.

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.

Media

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Media

Integrations Supported

Microsoft SharePoint

Integrations Supported

Microsoft SharePoint

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

25000.00
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

GxPLABS

Date Founded

2018

Company Location

India

Company Website

www.gxplabs.com

Company Facts

Organization Name

Xybion

Date Founded

1977

Company Location

United States

Company Website

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

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

ELN

Learning Management Systems (LMS)

Academic / Education
Asynchronous Learning
Blended Learning
Built-In Course Authoring
Corporate / Business
Customizable
Gamification
Learner Portal
Mobile Learning
Open Source
SCORM Compliance
Synchronous Learning
Video Conferencing
eCommerce
eLearning Companies

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

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

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