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Description
IntegPro is a specialized solution tailored to assist organizations in conducting risk assessments across all systems, thereby facilitating the tracking, prioritization, and management of compliance status within the company. Following the FDA's directives on data integrity, this software empowers quality leaders, departmental heads, and system owners to quickly ascertain their data integrity compliance, identify compliance deficiencies, and implement corrective measures. The application adheres to the requirements of 21 CFR Part 11, enabling seamless paperless management and monitoring of data integrity status. It is designed to be utilized by individual departments or as part of a broader corporate initiative focused on compliance with data integrity standards. With its user-friendly interface, IntegPro serves as an efficient tool for streamlining the management and tracking of data integrity processes throughout your organization. Additionally, it offers a convenient paperless solution for monitoring compliance status, ensuring that your company can maintain high standards of data integrity. The software comes ready to use, complete with pre-configured settings for immediate deployment, making it an accessible option for organizations of any size.
Description
Validfor is a robust and secure digital validation platform that consolidates the entire validation process into a single, paperless system, specifically tailored for industries that are heavily regulated. This platform not only streamlines validation tasks but also guarantees adherence to critical standards such as GAMP 5, 21 CFR Part 11, and EU Annex 11.
With capabilities for handling electronic records and advanced electronic signatures, Validfor ensures complete audit trails, role-specific workflows (including Author, Reviewer, and Approver), and thorough CSV compliance. It securely organizes all documentation and records within a centralized repository, meticulously tracking every modification to maintain data integrity and uphold Quality Assurance.
Additionally, Validfor provides integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, thereby facilitating smooth impact assessments, tracking of CAPA, Computer Software Assurance (CSA), and management of audit-ready lifecycles. This comprehensive approach not only enhances operational efficiency but also strengthens compliance across various validation activities.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
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
CIMINFO Software
Founded
1988
Country
United States
Website
www.part11solutions.com
Vendor Details
Company Name
Validfor
Founded
2024
Country
Estonia
Website
validfor.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