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Understanding FDA 21 CFR Part 11: A Guide for Life Science Developers

WTH is FDA 21 CFR Part 11? That’s a question many life science developers wanting to access the US market must...

5 min read

10 Steps for Seamless EQMS Data Migration

Transferring data to a new electronic Quality Management System (eQMS) can seem like a daunting prospect. Here...

3 min read

What happened at CogniCon24?

On the 16th of May, Cognidox welcomed nearly 100 attendees from across the high-tech, medical device, and phar...

3 min read

5 Steps to a Robust Corrective Action Process

It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...

6 min read

5 Challenges in Building a Pharmacovigilance System Master File

Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...

5 min read

The Importance of Document Control Systems in Business Operations

What does it mean to 'control documents'? And who needs a formal document control system to manage and optimis...

6 min read

Ultimate Guide to Deviation Management in Pharma & Bioscience

Managing deviations from standard operational procedures is critical to product quality and regulatory complia...

6 min read

Announcing CogniCon 24 - save the date!

The Cognidox team is delighted to announce we will be hosting CogniCon 24 on 16 May 2024. This is a networking...

1 min read

Enhancing Document Management: Why Google Drive Falls Short

Google Drive is a cloud-based program that allows you to create, edit, store, and share documents. Many busine...

5 min read

Mastering ICH Q8 R2: A Guide to Pharma Excellence

ICH Q8 R2 are international guidelines for ensuring Quality by Design in pharmaceutical development. Here’s wh...

4 min read

Mastering Non-Conformance Reports: A Guide for Quality Management

How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...

6 min read

Making the Switch: Transforming Your TMF into an eTMF

A Trial Master File (TMF) is a comprehensive collection of documents that ensures the conduct of your clinical...

4 min read

The Vital Role of ALCOA Principles in Data Integrity for Life Sciences

Data integrity is central to the safe development and manufacturing of every life-science product on the marke...

5 min read

Navigating ISO 13485: 8 Key Clauses for Medical Device QMS Excellence

Navigating the complexities of ISO 13485:2016 can seem daunting, but understanding its requirements is crucial...

6 min read

Medical Device Technical File requirements: what you need to know

What is the medical device technical file? What should it contain and how should it be structured? And is it e...

6 min read

Moving from Paper to Digital: Overcoming QMS Challenges

The case for ditching paper based QMS (Quality Management Systems) can seem like a no-brainer. But faced with ...

4 min read

Understanding ICH Q10 Pharmaceutical Quality System Guidelines

In 2008, the ICH Q10 Pharmaceutical Quality System (PQS) guidelines introduced a comprehensive model for an ef...

5 min read

Comparing eQMS Solutions: Qualio Vs Cognidox

Cognidox and Qualio are both digital quality management systems (QMS) with a focus on the life science and med...

4 min read

Design verification and design validation for medical device developers

In medical device development, two critical stages of the design process are often confused: design verificati...

6 min read

MDSAP 101: An Introduction to the Medical Device Single Audit Programme

What if you could gain approval to sell your medical devices anywhere in the world, by completing a single, re...

3 min read

What’s the Cost of Quality? Can it really be free?

What’s the cost of quality? Can it, like QM guru Philip Crosby argued, really be free? Like most things in bus...

4 min read

Equipment Validation in Life Sciences: A Comprehensive Guide

Controlling and documenting IQ, OQ and PQ effectively is a complex and time-consuming process for life science...

5 min read

Demystifying Medical Device Audits: Requirements, Process, and Impact

Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...

5 min read

Cognidox announces new e-signature integration with DocuSign

Cognidox are delighted to announce the release of our new DocuSign e-signature integration. The new plug in is...

2 min read

Navigating UKCA Marking for Medical Devices: What You Need to Know

Post-Brexit there has been some confusion about the future use of UKCA (UK Conformity Assessed) markings and w...

4 min read

Effective GxP Compliance: Managing Change Control for Safety

Change control in life science development is critical to ensuring the safety of patients. Having a formal pro...

4 min read

The Importance of Flexible eQMS in Semiconductor Success

Chip designs are becoming more complex and expensive to develop, verify and validate. Opportunities for fables...

4 min read

Managing Clinical Trials: Meet GCP Guidelines with Cognidox

Clinical research demands strict GCP (Good Clinical Practice) compliance. But many institutions stuck with out...

4 min read

FDA Regulation Update: QMSR and ISO 13485:2016 Explained

At last! It’s happened! The FDA has announced the date for the publication of its new Quality Management Syste...

5 min read

Streamlining Medical Device Design Transfer: Key Steps for Success

Transferring design to production is a process that can be fraught with risk for medical device developers. Ho...

3 min read

8 Tips for Effective SOP Documentation

There are many reasons why organisations need to document their SOPs. From ensuring uniformity in end products...

4 min read

Document Control Software for ISO 9001 & ISO 13485: A Guide

There’s plenty of document management and file-sharing software available on the market, but not all of it is ...

4 min read

Quality Management Maturity Grid: A Roadmap to Excellence

Of all the quality management ‘gurus’, the late Philip Crosby is one of the most readable. In his book ‘Qualit...

3 min read

Mastering Medical Device Development: An A-Z Guide of Acronyms

The regulations and literature surrounding medical device development are packed with acronyms and technical t...

9 min read

The Pros and Cons of Phase Gate Processes in New Product Development

Will a phase gate process hold back or enhance your new product development? What are the pros and cons of sta...

5 min read

Is SharePoint the Right Choice for Your Medical Device QMS?

A Quality Management System (QMS) is a requirement for medical device developers across the globe. But should ...

4 min read

Evolving Quality Management: From Ad Hoc to Chaordic

How can you help your business evolve its mindset to achieve the most instinctive, frictionless and effective ...

4 min read

7 Key Considerations Before Using Dropbox for Document Management

Dropbox is an easy to use cloud storage and sync application that is increasingly used in work settings for fi...

5 min read

Demystifying FDA 21 CFR Part 820: A Comprehensive Guide

The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...

5 min read

5 Phases of Developing Medical Devices: A Comprehensive Guide

The medical device development process is typically broken down into five distinct phases. Each one requires i...

5 min read

Building Your Digital QMS: Is Microsoft Software the Right Choice?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...

5 min read

The Importance of Equipment Calibration in ISO 13485 and ISO 9001

Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure th...

4 min read

Understanding Document Control in ISO 9001:2015

Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...

4 min read

4 Steps to Effective Supplier Quality Management

How do you transform regular supplier reviews from a box-ticking exercise into a genuinely useful commercial a...

6 min read

Is Sharepoint a Document Management System?

What’s wrong with SharePoint, anyway? Why shouldn’t it be used as a document management system (DMS) for a gro...

5 min read

How is Software as a Medical device (SaMD) regulated by the FDA?

Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...

5 min read

Understanding the Differences: ISO 9001 vs ISO 13485

ISO 9001 is the internationally recognised standard for quality management used in many sectors from construct...

4 min read

Understanding Post-Market Surveillance for Medical Devices in the EU

The PIP scandal, in which thousands of women were injured by faulty breast implants over a period of twenty ye...

4 min read

8 Tips for Streamlining Your Document Review Process

How is the quality of your document review process affecting the speed and efficiency of the way you do busine...

3 min read

5 Reasons Why You Need Document Version Control Software

We’ve all been there. We’ve lovingly put the final touches to that important document and saved it to the shar...

3 min read

Understanding Medical Device Classification: MD, IVD, AIMD, or SaMD?

Question for you: what exactly is a medical device? Is the product you are developing a Medical Device, an In ...

5 min read

What’s the plan? A seamless product realisation process for ISO 13485

So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision ...

4 min read

FDA CAPA Requirements: Ensuring Compliance and Quality Control

Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...

4 min read

Understanding QMS, eQMS, and eDMS for Quality Management Success

There are different ways companies can build required quality management systems, from using traditional paper...

5 min read

Compiling a design & development plan for your medical device

What are the planning requirements for a medical device design and development process? And what tools can hel...

5 min read