Average Ratings 1 Rating

Total
ease
features
design
support

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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

Screenshots View All

Integrations

Docusign No 
Microsoft 365 No 

Integrations

Docusign Yes 
Microsoft 365 Yes 

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

Alternatives

Alternatives

AmpleLogic eBMR Reviews

AmpleLogic eBMR

AmpleLogic
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences