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About

Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals.

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 Supported
iPad Supported
Android 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

Ideal for mid-sized businesses and Fortune 500 companies seeking fast time-to-value and return on investment.

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

Varies, depends on plan chosen
Free Version Not 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 4.7 / 5
ease 4.6 / 5
features 4.9 / 5
design 4.6 / 5
support 4.7 / 5

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

  • Applications are easy to set up, even if legacy data must be imported. The "OOTB" versions work well, and making configuration changes to customize can be done without IT support. The platform includes the basics needed to get a QMS started, and offers a wide array of applications, which can be added as the organization grows.
  • Very user friendly platform, Trainers and implementation team are very helpful. The applications are very well designed and are very thorough. Prompt reply and help on inquiries.
  • Platform can be completely customized as a user needs. Can build templates, workflows, tables, apps, etc. Work well as a cloud app as to not be affected by company firewalls/servers. Most of the design practices make sense across the apps. Ability to add mass amounts of data works well. Admin panel & audit features are a great plus. Great error/troubleshooting logs.
  • The site is robust and highly customizable. A well-structured work team. Good customer service from instructors and programmers. An training material is included with our site, and also they have a support platform.
  • I am currently in implementation of this product. The training is amazing, and the software is incredibly customizable. This QMS would work for any scale company and in almost any industry. I love the mobile features as well, that stands out from the competition.

Cons

  • Although a truly "no code" architecture, the configuration changes must be done thoughtfully and carefully, but the Design-Test-Live methodology prevents mistakes. Expect a learning curve for administrators.
  • No bad experience at all. Sales person was amazing and gave us a discount.
  • Depending on your company needs, some apps require much more customization than others. Design speeds depend drastically on which version a user is on. Some on screen errors don't allow for much interpretation or troubleshooting. Site can sporadically log users out.
  • A single customization could require multiple alterations across various tables and processes, which increases the the possibility of errors. The OOTB package is not clear. It is important to define if Intellect will help us to configure and see if it is possible the configurations that we request, since at the moment of the sale everything is "YES", however, it is important to define it beforehand to avoid surprises.
  • Nothing, I haven't found anything that isn't working well in the system.

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

Intellect
Founded: 2000
United States
www.intellect.com

Company Information

qmsWrapper
Canada
www.qmswrapper.com

Alternatives

Alternatives

Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems
QT9 QMS

QT9 QMS

QT9 Software
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Intelex

Intelex

Intelex Technologies

Categories

Categories

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management 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 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

Business Process Management Features

Access Controls / Permissions Supported
Alerts / Notifications Supported
Business Process Automation Supported
Business Rules Management Supported
Collaboration Supported
Process Change Tracking Supported
Process Mapping Supported
Process Modeling & Design Supported
Visual Workflow Management Supported

Calibration Management Features

Calibration Instructions Supported
Calibration Schedules Supported
Compliance Management Supported
Device History Supported
Due Date Tracking Supported
Gage Management Supported
Label Printing Supported
Measurement Readings Supported
Multi-Station Management Supported
Out-of-Tolerance Notification Supported
Statistical Data Reporting 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 Supported
Surveys & Feedback Supported
Version Control Supported
Workflow / Process Automation Supported

Contract Management Features

Buy Side (Suppliers) Supported
Completion Tracking Supported
Compliance Tracking Supported
Contract Lifecycle Management Supported
Electronic Signature Supported
Full Text Search Not Supported
Government Contracts Supported
Pre-built Templates Supported
Sell Side (Customers) Supported
Specialty Contracts Supported
Version Control Supported
Workflow Management Supported

Document Control Features

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

Document Management Features

Access Controls Supported
Archiving & Retention Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Supported
Document Capture Not Supported
Document Conversion Supported
Document Delivery Supported
Document Indexing Supported
Document Retention Supported
Electronic Signature Supported
Email Management Supported
File Recovery Supported
File Type Conversion Supported
Forms Management Supported
Full Text Search Not Supported
Offline Access Supported
Optical Character Recognition Not Supported
Print Management Not Supported
Version Control Supported

Document Version Control Features

Access Controls/Permissions Supported
Approval Process Control Supported
Archiving & Retention Supported
Audit Trail Supported
Commenting / Notes Supported
Document Check-in / Check-out Supported
For Engineering Documents Supported
Revision History Supported
Version Comparison Supported
Version Rollback 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 Supported
Graphical Workflow Editor Supported
Mobile Access Supported
No-Code 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

Docusign Supported
Jira Not Supported
Microsoft Azure Supported
Microsoft Dynamics 365 Supported
Microsoft Excel Supported
Microsoft SharePoint Supported
Microsoft Word Supported
NetSuite Supported
Okta Supported
Oracle CRM On Demand Supported
Ping Identity Supported
Salesforce Supported
Traverse Supported
Workday Extend Supported
Zapier Supported
transcendAP Supported

Integrations

Docusign Not Supported
Jira Supported
Microsoft Azure Not Supported
Microsoft Dynamics 365 Not Supported
Microsoft Excel Not Supported
Microsoft SharePoint Not Supported
Microsoft Word Not Supported
NetSuite Not Supported
Okta Not Supported
Oracle CRM On Demand Not Supported
Ping Identity Not Supported
Salesforce Not Supported
Traverse Not Supported
Workday Extend Not Supported
Zapier Not Supported
transcendAP Not Supported
Claim Intellect and update features and information
Claim Intellect and update features and information
Claim qmsWrapper and update features and information
Claim qmsWrapper and update features and information