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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
TraxQM is a risk-oriented Quality Management System (QMS) aimed at assisting organizations in navigating regulatory compliance, optimizing quality workflows, and boosting operational effectiveness via a unified, AI-driven platform. This system empowers businesses to adopt a proactive stance toward compliance by digitizing their procedures and implementing structured approaches that comply with global standards like ISO and GxP. Featuring essential modules for managing documents, conducting risk assessments, overseeing Corrective and Preventive Actions (CAPA), implementing change control, executing audits, and facilitating training, TraxQM allows teams to handle the entire spectrum of quality operations within a single system. The platform ensures data integrity through features like automated version control, audit trails, and compliant electronic signatures, which guarantee traceability and adherence to regulatory mandates. Furthermore, TraxQM utilizes artificial intelligence to bolster decision-making by evaluating risks, proposing specific control measures, and recommending pertinent Key Performance Indicators (KPIs) aligned with the organization’s goals, thereby enhancing overall quality management capabilities. Ultimately, this comprehensive QMS not only streamlines processes but also empowers teams to foster a culture of continuous improvement in their quality practices.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Docusign
No
Microsoft 365
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$403.97 per month
Free Trial
No
Free Version
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
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)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
AmpleLogic
Founded
2010
Country
India
Website
www.amplelogic.com
Vendor Details
Company Name
TraxQM
Country
United States
Website
www.traxqm.com