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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
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

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
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

Varies, depends on plan chosen
Free Version
Free Trial

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
Free Trial

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 4.6 / 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 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
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

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

Quality Management Features

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

Audit Features

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

Business Process Management Features

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

Calibration Management Features

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Contract Management Features

Buy Side (Suppliers)
Completion Tracking
Compliance Tracking
Contract Lifecycle Management
Electronic Signature
Full Text Search
Government Contracts
Pre-built Templates
Sell Side (Customers)
Specialty Contracts
Version Control
Workflow Management

Document Control Features

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

Document Management Features

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Document Version Control Features

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Workflow Management Features

Access Controls/Permissions
Approval Process Control
Business Process Automation
Calendar Management
Compliance Tracking
Configurable Workflow
Customizable Dashboard
Document Management
Forms Management
Graphical Workflow Editor
Mobile Access
No-Code
Task Management
Third Party Integrations
Workflow Configuration

CAPA Features

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

Quality Management Features

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

Integrations

Docusign
Jira
Microsoft Azure
Microsoft Dynamics 365
Microsoft Excel
Microsoft SharePoint
Microsoft Word
NetSuite
Okta
Oracle CRM On Demand
Ping Identity
Salesforce
Traverse
Workday Extend
Zapier
transcendAP

Integrations

Docusign
Jira
Microsoft Azure
Microsoft Dynamics 365
Microsoft Excel
Microsoft SharePoint
Microsoft Word
NetSuite
Okta
Oracle CRM On Demand
Ping Identity
Salesforce
Traverse
Workday Extend
Zapier
transcendAP
Claim Intellect and update features and information
Claim Intellect and update features and information
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