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What is ZipQuality?

ZipQuality delivers a software-centric service aimed at assisting medical device manufacturers in the successful launch of pioneering products. Our collaborative platform skillfully handles rapid design changes for agile teams while ensuring compliance with regulatory requirements. Featuring a pre-configured system that integrates essential processes and tools, there's no need for alterations to your established quality system. The unified platform effectively supports quick design revisions for product documentation, maintaining consistency throughout. Our experienced consultants provide guidance to your team at every stage of the journey. Built upon the powerful ENOVIA platform, our extensive and scalable software solutions are customized to cater to your specific needs. This integrated approach enables swift design modifications while guaranteeing that product documentation and data are kept in sync, ensuring that all records are audit-ready. We address critical aspects such as product specifications, hardware, and software requirements, with a deep understanding of the challenges posed by software-intensive medical devices. The ZipQuality framework is designed around a methodical documentation strategy that strengthens systems engineering, fosters robust risk management, and guarantees clear traceability, thus becoming an essential tool for any medical device enterprise. Furthermore, our dedication to continuous enhancement ensures that we consistently refine our service offerings to stay in line with the latest developments in the industry, providing added value to our clients. In this ever-evolving landscape, having a partner like ZipQuality is crucial for maintaining a competitive edge.

What is QEdge?

QEdge by Sarjen Systems is a robust and highly specialized Enterprise Quality Management System (EQMS) specifically engineered for the nuanced requirements of pharmaceutical manufacturing and the broader life sciences industries. This comprehensive solution is designed to meticulously address diverse quality challenges while ensuring unwavering compliance with stringent global regulatory standards such as FDA, EU-GMP, and ICH guidelines. QEdge significantly streamlines and automates a wide array of critical quality processes, including Change Control, Deviation management, Corrective and Preventive Actions (CAPA), efficient Document Management, and structured Training programs. It incorporates key features like robust SOP lifecycle management and SCORM-based eLearning capabilities, enhancing user experience and effectiveness. The system's design ensures audit-ready compliance tracking, contributing profoundly to operational excellence, impeccable data integrity, and regulatory readiness within demanding GxP environments. By facilitating superior process control, automating essential tasks like PQR/APQR, and simplifying vendor qualification, QEdge ultimately drives greater efficiency, mitigates risks, and elevates overall quality management throughout an organization's operations.

Media

Media

Integrations Supported

SAP Store

Integrations Supported

SAP Store

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Consensia

Company Location

United States

Company Website

consensiainc.com/zipquality/

Company Facts

Organization Name

Sarjen Systems Pvt Ltd

Date Founded

1998

Company Location

India

Company Website

qedge.sarjen.com

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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