qmsWrapper

qmsWrapper

4.7 out of 5 stars
AssurX qmsWrapper

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AssurX:

About

The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify.
qmsWrapper:

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.
AssurX:

Platforms Supported

Windows Supported
Mac Supported
Linux Supported
Cloud Supported
On-Premises Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Supported
qmsWrapper:

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
AssurX:

Audience

Pharmaceutical, Biotechnology, Medical Device, High Tech Manufacturing, Energy & Utilities, Food & Beverage, and others.
qmsWrapper:

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
AssurX:

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported
qmsWrapper:

Support

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

API

Offers API Supported
qmsWrapper:

API

Offers API Not Supported
AssurX:

Screenshots and Videos

qmsWrapper:

Screenshots and Videos

AssurX:

Pricing

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

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 Not Supported
AssurX:

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:

Review this Software
qmsWrapper:

Reviews/Ratings

Overall 4.7 / 5
ease 4.5 / 5
features 4.6 / 5
design 4.1 / 5
support 4.8 / 5
qmsWrapper:

Pros & Cons from Real Users

Pros

  • I like having documents, training, CAPAs, risks and other QMS activities in one place. It saves a lot of time compared with working across different files and tools, and it is much easier to see how things are connected. I also like that the system is flexible and we can adjust processes when needed.
  • 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.

Cons

  • There is a bit of a learning curve at the beginning because there are a lot of features. Some areas could also be a little more intuitive, but once you get used to the system, everyday work becomes quite straightforward.
  • 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.
AssurX:

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported
qmsWrapper:

Training

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

Company Information

AssurX
Founded: 1993
United States
www.assurx.com
qmsWrapper:

Company Information

qmsWrapper
Canada
www.qmswrapper.com
AssurX:

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AssurX:

Categories

qmsWrapper:

Categories

AssurX:

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 Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Supported
Forms Management Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Supported
Risk Assessment Supported
Workflow Management Supported

Complaint Management Features

Case Management Not Supported
Complaint Classification Supported
Corrective Actions (CAPA) Supported
Customer Complaint Tracking Supported
Feedback Management Supported
Forms Management Supported
Issue Tracking Supported
Quality Assurance Management Supported
Routing Supported
Self Service Portal Not Supported
Social Media Monitoring Not Supported
Survey Management Not Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Supported
Version Control Supported
Workflow / Process Automation Supported

Energy Management Features

Benchmarking Not Supported
Bill Audit Not Supported
Bill Database Not Supported
Bill Importing Not Supported
Budgeting & Forecasting Not Supported
Compliance Management Supported
Contract Management Not Supported
Cost / Use Reporting Not Supported
Emissions Monitoring Not Supported
Energy Price Analysis Not Supported
Facility Scheduling Not Supported
Greenhouse Gas Tracking Not Supported
Load Control Not Supported
Load Forecasting Not Supported
Meter Tracking Not Supported
Risk Management Supported
Weather Normalization Not Supported

Manufacturing Features

Accounting Integration Not Supported
ERP Not Supported
Maintenance Management Not Supported
MES Not Supported
MRP Not Supported
Purchase Order Management Not Supported
Quality Management Supported
Quotes/Estimates Not Supported
Reporting/Analytics Not Supported
Safety Management Supported
Shipping Management Not Supported
qmsWrapper:

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

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
AssurX:

Integrations

Agile CRM Supported
Blue Link ERP Supported
Expandable Supported
JD Edwards EnterpriseOne Supported
Jira Not Supported
Microsoft Access Supported
Microsoft Azure Supported
Microsoft Cognitive Toolkit Supported
Microsoft Dynamics 365 Supported
Oracle BPM Suite Supported
Oracle Business Intelligence (OBIEE) Supported
Oracle CRM On Demand Supported
Oracle Cloud Infrastructure Supported
QUMAS EQMS Supported
SAP Analytics Cloud Supported
SAP Business One Supported
SAP BusinessObjects Business Intelligence Supported
SAP CRM Supported
SAP Crystal Reports Supported
Salesforce Supported
qmsWrapper:

Integrations

Agile CRM Not Supported
Blue Link ERP Not Supported
Expandable Not Supported
JD Edwards EnterpriseOne Not Supported
Jira Supported
Microsoft Access Not Supported
Microsoft Azure Not Supported
Microsoft Cognitive Toolkit Not Supported
Microsoft Dynamics 365 Not Supported
Oracle BPM Suite Not Supported
Oracle Business Intelligence (OBIEE) Not Supported
Oracle CRM On Demand Not Supported
Oracle Cloud Infrastructure Not Supported
QUMAS EQMS Not Supported
SAP Analytics Cloud Not Supported
SAP Business One Not Supported
SAP BusinessObjects Business Intelligence Not Supported
SAP CRM Not Supported
SAP Crystal Reports Not Supported
Salesforce Not Supported
AssurX:
Claim AssurX and update features and information
Claim AssurX and update features and information
qmsWrapper:
Claim qmsWrapper and update features and information
Claim qmsWrapper and update features and information