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Lean eQMS

A Quality Management System right-sized to your needs

Document Management

Digitise your document control

Design Controls

Phase gate and document your entire design process

Publishing & Collaboration

Fast and secure information management

Learning Management

Integrated LMS for training, assessments, and streamlined onboarding

CAPAs & Non-conformance

Detect, correct and prevent quality failures

e-Signatures

Integrate FDA and ISO 13485 compliant e-signatures into your eQMS

Supplier Management

Monitor and manage supply chain quality

Business Management System

Ensure oversight and control with graphical business management

Change Management

Change control when it matters most

Software Validation

Support for GxP and FDA software validation requirements

eTMF/eISF

Manage documentation and ensure audit readiness
Industries

Medical Devices

Streamlined eQMS for medical device & IVD development

High Tech Products

Quality and document management platform to control complex development

Biotech & Pharma

GxP compliant eQMS for life sciences teams

Consultants

Grow your revenue with a hosted eQMS for your clients

CROs & CMOs

GxP compliance solution for regulated environments
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Alexander Thomson| eIFU

How to publish electronic Instructions for Use (eIFU) safely and compliantly

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Clinical trial document management
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eIFU
Fabless Semiconductor Design
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ISO 9001:2015
Learning Management System
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Open Source Software
Product Management
Quality Management System
Training Management

how to publish eifus

How to publish electronic Instructions for Use (eIFU) safely and compliantly

Electronic Instructions for Use (eIFU) are increasingly accepted by regulators and customers, particularly for...

5 min read

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Lean eQMS
Document Management
Design Controls
Extranet & Collaboration
Business Management System
CAPAs & Non-conformance
e-Signatures
Supplier Management
Learning Management
Change Management
eTMF & eISF
Software Validation

Cognidox

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About

About Us
Case Studies
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Careers
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Resources

Medical Device Development Guide
Document Control for Medical Devices
eQMS Buyer's Guide
Guide to GxP Compliance
High Tech Product Development Guide
GxP Training Management Guide
eQMS Platform
Blog
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Industries

Medical Devices
Biotech & Pharma
CROs & CMOs
High Tech Products
Consultants

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