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Average Ratings 0 Ratings

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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

Ensuring uniform product quality and robust quality management procedures poses significant challenges in the current landscape of pharmaceutical manufacturing. Industries governed by strict regulations, including Pharmaceuticals, Biotechnology, and Life Sciences, must adhere to Good Manufacturing Practices (GMP) to comply with legal standards. Beyond merely fulfilling GMP obligations, it is essential to provide evidence of compliance. Relying on paper forms, isolated systems, or manual procedures to oversee, monitor, and document quality issues and responses fails to offer effective solutions for establishing cohesive and integrated quality management practices that align with industry standards. Consequently, organizations must seek more advanced and automated systems to enhance their quality assurance efforts and streamline compliance.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

No images available

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
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 Yes 
Mac Yes 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
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 Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

AmpleLogic

Founded

2010

Country

India

Website

www.amplelogic.com

Vendor Details

Company Name

Novatek International

Founded

1996

Country

Canada

Website

ntint.com/product/nova-qms/

Product Features

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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