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What is Xybion QMS?

Quickly revolutionize your compliance, quality, and risk management frameworks in an entirely digital and remote environment. Anticipate, reduce, and automate real-time compliance oversight, ensuring you are consistently ready for any compliance audits that may arise. In this fast-paced landscape, staying proactive is essential for success.

What is Validfor?

Validfor is a powerful and secure digital validation solution that brings all aspects of the validation process into one cohesive, paperless system, designed specifically for industries with stringent regulations. This platform effectively simplifies validation responsibilities while ensuring compliance with essential standards such as GAMP 5, 21 CFR Part 11, and EU Annex 11. By supporting electronic records and sophisticated electronic signatures, Validfor delivers complete audit trails and tailored workflows for different roles, including Author, Reviewer, and Approver, all while ensuring comprehensive CSV compliance. It systematically organizes all documentation and records in a centralized repository, diligently monitoring every change to preserve data integrity and uphold Quality Assurance. Moreover, Validfor includes integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, which aid in conducting seamless impact assessments, tracking Corrective and Preventive Actions (CAPA), managing Computer Software Assurance (CSA), and overseeing audit-ready lifecycles. This all-encompassing strategy not only boosts operational efficiency but also fortifies compliance throughout a wide range of validation activities, making it an indispensable tool for regulated industries. In this way, Validfor empowers organizations to navigate complex regulatory landscapes with confidence and precision.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Per user and server-based pricing
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Windows

Supported Platforms

SaaS
Chromebook

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

Xybion

Date Founded

1977

Company Location

United States

Company Website

www.xybion.com

Company Facts

Organization Name

Validfor

Date Founded

2024

Company Location

Estonia

Company Website

validfor.com

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

Compliance

Audit Management
Compliance Tracking
FDA Compliance
ISO Compliance
Incident Management
Risk Management
Sarbanes-Oxley Compliance
Version Control

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management

Risk Management

Alerts/Notifications
Auditing
Compliance Management
Corrective Actions (CAPA)
Dashboard
Internal Controls Management
Mobile Access
Operational Risk Management
Risk Assessment

Categories and Features

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