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Description
AmpleLogic's AI-based APQR software provides a revolutionary solution for generating precise Product Quality Review (PQR) and CPV reports that meet the stringent requirements of current Good Manufacturing Practices (CGMP) regulations (21 CFR 211.180(e)). By utilizing OCR for data extraction and integrating AI-driven chatbot technology, this software significantly speeds up the document data extraction process and provides faster access to critical information. As a result, businesses can improve audit preparedness, ensure timely regulatory submissions, and streamline their operational workflows to maintain compliance and efficiency.
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
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Integrations
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Integrations
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Pricing Details
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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
AmpleLogic
Founded
2010
Country
India
Website
www.amplelogic.com
Vendor Details
Company Name
Validfor
Founded
2024
Country
Estonia
Website
validfor.com