The latest news and updates from cognidox

11 myths about ISO 9001 - busted!

Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...

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What are the FDA's requirements for CAPA (Corrective and Preventive Action)

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

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Can Product Innovation Tools help you go 'virtual first?'

Colocation was one of the central tenets of the Agile manifesto, but times have changed. With all the new digi...

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A 21 CFR Part 11 checklist: 7 key FDA e-signature requirements

How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...

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Why your QMS needs to be an eQMS

If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...

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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...

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12 issues with virtual team collaboration tools that should worry you

As your computer waits to load up Teams, Zoom, Slack, Accello and countless other collaboration apps every mor...

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Quality Control Vs Quality Assurance. How are they different?

What’s the difference between Quality control and Quality Assurance?

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Pros and cons of a phase gate process 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...

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