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About

SoftTech Health offers the most comprehensive suite of quality management software tools available in healthcare today. And since they integrate seamlessly, you’ll be able to streamline all your quality management tasks within one easy-to-use software package. Our Accreditation Manager helps you manage any upcoming inspections with tools to help you compare and copy over existing work from previous inspections. Automatically track proof of compliance and ensure nothing falls through the cracks. With every inspection, you want to: make sure that none of the requirements fall through the cracks; cut time to coordinate, track, and report on the audit; and streamline the time-consuming process of gathering your supporting evidence. The Accreditation Manager automates all these processes, improving both compliance and the bottom line at the same time.

About

qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance. Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Supported
Linux Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Healthcare organizations looking for an inspection management software with tools for previous data and compliance track

Audience

Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

€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 Not Supported
Free Trial Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Reviews/Ratings

Overall 4.7 / 5
ease 4.6 / 5
features 4.6 / 5
design 4.1 / 5
support 4.8 / 5

Pros & Cons from Real Users

Pros

  • I love the interface and the helpful dashboard that reminds you daily of tasks related to you. The Quality Manual is editable and free to use, making it very user-friendly. Custom templates, notifications, automation, and risk management features are ideal for small and medium-sized companies. The technical support is excellent, answering all our questions quickly and accurately. If we need additional explanation, they are happy to schedule video training for us. Additionally, it's great for managing all kinds of projects, not just those related to quality. Documentation management, including approvals, revision history, and organization in folders, is straightforward. The Traceability Matrix is the best I've seen and very easy to use. The new Risk Module is very helpful with its added questions.
  • Robust process engine automates workflows, minimizing errors and improving efficiency. Responsive development team actively listens to user feedback and implements requested features.
  • Managing with qmsWrapper is easy, I am using it to organize my department. The team works easily and everything is recorded in detail in the system.
  • qmsWrapper is an exceptional QMS software that has transformed our quality management processes. The software is intuitive and the modules are meticulously designed. The traceability matrix capability provides valuable insights into the relationships between requirements, tests, and other project elements, enhancing overall quality and compliance.
  • It is user-friendly software, flexible, and can be integrated if you are a Jira user. It is especially intended for small companies that need a QMS. Things that I like and use daily: tasks, document approval, sending doc for review, creating new forms (managing forms), team chat for meetings, and daily conversations.

Cons

  • Sometimes you need to refresh the page for updates to show
  • Primarily designed for small and medium-sized companies, limiting functionality for larger enterprises.
  • Sometimes slow, but regardless, I can work without interruption.
  • While qmsWrapper offers impressive features, some users may experience slight slowness in the software's performance. However, this minor issue does not significantly impact its overall functionality or hinder the effectiveness of the quality management processes.
  • What I don't like is that it is aimed at small companies because I feel that this kind of software would be very useful for companies that have 100+ employees. They should develop in that direction.

Training

Documentation Not Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

SoftTech Health
Founded: 2003
United States
softtechhealth.com/products/

Company Information

qmsWrapper
Canada
www.qmswrapper.com

Alternatives

Alternatives

Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Xybion QMS

Xybion QMS

Xybion

Categories

CAPA Supported
Quality Management Supported

Categories

Accreditation Management Features

Collaboration Supported
Compliance Management Not Supported
Document Management Supported
Higher Education Not Supported
Requirements Management Not Supported
Reviewer Portal Not Supported
Self Assessment Not Supported
User Access Permissions Not Supported
Workflow Management Not Supported

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Not Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Supported
Training Management Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Not Supported
ISO Standards Management Supported
Maintenance Management Not Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Integrations

Jira Not Supported

Integrations

Jira Supported
Claim SoftTech Health and update features and information
Claim SoftTech Health and update features and information
Claim qmsWrapper and update features and information
Claim qmsWrapper and update features and information