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Average Ratings 10 Ratings

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support

Description

Cognidox is an online document-management system for high-tech, life sciences and medical device product development. Cognidox is available in the cloud and as an on-premise solution. It promotes product lifecycle management and knowledge sharing between developers and clients, partners, customers, and customers. Cognidox is secure and reliable. We offer plug-ins for many programs, such as Microsoft Office. We also offer an API that allows you to integrate almost any process with Cognidox. Cognidox's core function is a DMS. An add-on for Cognidox allows you to license and distribute documents to third parties via a fully sandboxed website. This allows you to publish specific documents while keeping your main storage secure. Another popular add-on is gBMS - Graphical Business Management System. Visio can be used to capture your business processes. A good BMS should give clear oversight of your entire operation.

Description

qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform. Best For: - Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS. - Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Jira No 
Microsoft 365 Yes 
Salesforce Yes 

Integrations

Jira Yes 
Microsoft 365 No 
Salesforce No 

Pricing Details

£10 p/user
We have 3 packages available for hosting, Start up, Scale Up and Enterprise. The Start Up package is the core system for 10 people, if you outgrow that then there is the Scale Up package which is a 20 user minimum at £15 per user for the first 25 users then each user over that is an extra £10 till you reach 100 users after which each user is then just £8.50. For companies over the size of 40 - 50 users we recommend our enterprise package for which we will work with you to get the best fit for your organisation
Free Trial Yes 
Free Version No 

Pricing Details

€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 Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux Yes 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac Yes 
Linux Yes 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Cognidox Ltd

Founded

2008

Country

United Kingdom

Website

www.cognidox.com

Vendor Details

Company Name

qmsWrapper

Country

Canada

Website

www.qmswrapper.com

Product Features

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management No 
OSHA Compliance No 
Risk Management No 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation No 

Document Management

Access Controls Yes 
Archiving & Retention Yes 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management Yes 
Full Text Search Yes 
Offline Access No 
Optical Character Recognition No 
Print Management No 
Version Control Yes 

Document Version Control

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

File Sharing

Audit Trail Yes 
Chat / Messaging No 
Collaboration Yes 
Document Management Yes 
Drag & Drop No 
Electronic Signature Yes 
Encryption No 
File Synchronization No 
Search Yes 
User Management Yes 
Version Control Yes 
Workflow Management Yes 

Forms Automation

Approval Process Control No 
Archiving & Retention No 
Collaboration No 
Document Indexing No 
Drag & Drop No 
Full Text Search No 
Remote Document Access No 
Rules-Based Workflow No 
Text Editing No 
Version Control No 

Human Resources

360 Degree Feedback No 
Applicant Tracking No 
Attendance Management No 
Benefits Management No 
Career Development Planning No 
Compensation Management No 
Compliance Management No 
Employee Database No 
Employee Lifecycle Management No 
Onboarding No 
Payroll Management No 
Performance Management No 
Recruiting Management No 
Self Service Portal No 
Succession Planning No 
Time & Attendance Management No 
Time Off Management No 
Timesheets No 
Training Management No 

Project Management

Agile Methodologies No 
Budget Management No 
Client Portal No 
Collaboration Tools No 
Cost-to-Completion Tracking No 
Customizable Templates Yes 
Gantt Charts No 
Idea Management No 
Kanban Board No 
Milestone Tracking Yes 
Portfolio Management No 
Resource Management No 
Time & Expense Tracking No 
Traditional Methodologies No 

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management No 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

Product Features

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management No 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management No 
ISO Standards Management Yes 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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