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What is qmsWrapper?

qmsWrapper is a connected Quality Management System (eQMS) designed specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, companies can start with Foundation and expand to Lifecycle and Vigilance as their quality system matures. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects document control, training, CAPA, quality events, risk management, technical documentation, supplier quality, and traceability in one platform. AI assists users with quality processes while every action remains human-controlled and fully auditable. Start where the need is greatest. Keep everything you build. Grow your QMS without rebuilding or migrating to another system.

What is QAPI360?

QAPI360 is an all-encompassing, cloud-based software solution tailored for Quality Assurance Performance Improvement (QAPI) that adheres to HIPAA regulations, empowering healthcare providers to consolidate, organize, and oversee every facet of their quality programs. By transitioning from outdated spreadsheets and fragmented approaches, healthcare agencies can embrace a systematic, data-informed framework that encompasses clearly defined QAPI plans, quality metrics, and systems for tracking incidents related to both patients and staff. The software is equipped with features such as infection control monitoring, documentation for medication errors and adverse drug reactions, initiatives for hand hygiene, templates for performance improvement projects, evaluations of patient satisfaction, and oversight of contracted provider performance, all presented through dynamic dashboards that help users detect trends, implement corrective actions, and assess outcomes effectively. Furthermore, QAPI360 streamlines data entry, offers support for EMR integration or automated data imports, and includes built-in reporting tools, making compliance documentation and audits more efficient while also enhancing the processes of data collection, charting, and root-cause analysis. Additionally, this powerful software acts as an essential tool for healthcare agencies aiming to elevate their quality assurance efforts and guarantee the highest standards of patient care. In conclusion, the implementation of QAPI360 can significantly transform the way organizations manage quality performance, ultimately leading to improved health outcomes for patients.

Media

Media

Integrations Supported

Jira

Integrations Supported

Jira

API Availability

Has API

API Availability

Has API

Pricing Information

€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Version
Free Trial Offered?

Pricing Information

$249.99 per month
Free Version
Free Trial Offered?

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

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

Company Facts

Organization Name

QAPI360

Company Location

United States

Company Website

qapi360.com

Categories and Features

CAPA

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

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

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