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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 SimplerQMS?

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

Media

Media

Integrations Supported

Integrations Supported

Microsoft 365
Microsoft Entra ID

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
iPhone
iPad
Windows

Customer Service / Support

Standard Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Consensia

Company Location

United States

Company Website

consensiainc.com/zipquality/

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Categories and Features

Quality Management

Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management
Risk Management

Categories and Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Forms Management
Issue Management
Mobile Access
Risk Assessment
Workflow Management

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Training Management

Compliance

Archiving & Retention
Audit Management
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

ISO Compliance

Not specified

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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