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About

ExtraView is an enterprise software platform implementing business process management, global quality management systems for CAPA, adverse event reporting, food safety, bug and defect tracking, change management, customer support, helpdesk, field audit, and other workflow or issue management systems. Use out-of-the-box solutions or implement a custom requirement. Available as a service in the cloud or on your own servers. Simple to configure, yet provides a quality platform on which to implement fully validated systems such as incident management, CAPA, adverse event reporting, & root cause analysis, clinical trial data management and food safety. Implement bug-tracking, customer support, requirements management, change management and other issue-tracking systems. Many customers can take advantage of the full-featured, free, downloadable version! Learn how financial companies implement systems that regulate and control audit systems, provide corporate governance and risk management.

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 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

Businesses looking for an enterprise software platform implementing business process management

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 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

$400 one-time payment
Free Version Supported
Free Trial 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 4.5 / 5
features 4.6 / 5
design 4.1 / 5
support 4.8 / 5

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.

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

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

Company Information

ExtraView
Founded: 1999
United States
www.extraview.com

Company Information

qmsWrapper
Canada
www.qmswrapper.com

Alternatives

Alternatives

SBS Quality Management Software

SBS Quality Management Software

Sunday Business Systems
Backlog

Backlog

Nulab
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Jira

Jira

Atlassian

Categories

Bug Tracking Supported
Compliance Supported
Issue Tracking Supported

Categories

Bug Tracking Features

Backlog Management Supported
Filtering Supported
Issue Tracking Not Supported
Release Management Not Supported
Task Management Not Supported
Ticket Management Supported
Workflow Management Supported

Compliance Features

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

Issue Tracking Features

Assignment Management Supported
Dashboard Supported
Escalation Management Supported
Issue Auditing Supported
Issue Scheduling Supported
Knowledge Base Supported
Project Management Supported
Recurring Issues Supported
Scheduling Supported
Task Management Supported

Workflow Management Features

Access Controls/Permissions Supported
Approval Process Control Supported
Business Process Automation Supported
Calendar Management Supported
Compliance Tracking Supported
Configurable Workflow Supported
Customizable Dashboard Supported
Document Management Supported
Forms Management Not Supported
Graphical Workflow Editor Not Supported
Mobile Access Supported
No-Code Not Supported
Task Management Supported
Third Party Integrations Supported
Workflow Configuration 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
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Claim ExtraView and update features and information
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