The latest news and updates from cognidox

Corrective actions: why, when and how?

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

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Understanding the regulation: challenges for UK IVD device developers

IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...

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How secure is your virtual collaboration process?

Last year, Slack, Zoom and countless other companies hoovered up business as companies shifted to support new ...

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Will ISO certification give you a competitive edge?

The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...

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Digital Signatures: New MHRA guide clarifies remote approval requirements

A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...

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Why corrective action management goes wrong

ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action ...

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What is effective CAPA management?

Mastering CAPA management is part of the proactive quality mindset that regulators demand, but it is also an a...

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The New Year Honours Debacle: A document management disaster

We’ve all been there, haven’t we? We’ve all accidentally published online the addresses of hundreds of celebri...

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Organisational knowledge requirements in iso 9001:2015

The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledg...

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ISO 27001 and ISO 9001: How an integrated response can work

Many high tech businesses who are implementing a Quality Management System (QMS) to gain ISO 9001:2015, are in...

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ISO 26262: How can DMS solutions support the development of driverless tech?

Advanced Driver Assistance Systems (ADAS) and even driverless cars, once the stuff of science fiction, are rap...

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Riding the wave of the med-tech quality management challenge

Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...

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Are you developing a medical device?

Are you developing a medical device? And are you certain about that? It might sound like a crazy question. If ...

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Why the FDA want Proactive Quality Management Systems

Reports from the U.S. tell us the FDA is continuing to prioritise Proactive Quality Management in the medical ...

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Is your QMS just for ISO certification?

 Is ISO certification the only reward you’ll receive for jumping through all those QMS hoops? And is it really...

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ISO 13485:2016 - decoding the enigma

Developing medical devices can be a process fraught with challenges. As a startup or established business abou...

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How digital signatures can help secure regulatory compliance

Digital signatures are proving valuable tools for businesses developing products for release in highly regulat...

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Cognidox achieves full iSO 27001 certification

Cambridge, UK, 1 August 2018 - Cognidox, the leading provider of document management solutions for the high-te...

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Is your information safe? Document security in the information age

Most people think of document security only in relation to highly sensitive documents. However, the security o...

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10 Minutes to Save Yourself from Whaling

The CEO, CFO, COO of a company: the people in charge, the brains behind the whole organisation. If not totally...

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White Paper – How to apply Risk-based Thinking to ISO 9001:2015

For the past several months we've published a series of blog posts on the application of Risk-based Thinking f...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part XI]

There are twelve posts in this series. To read Part X, please click here. If you have been reading this blog r...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part X]

There are twelve posts in this series. To read Part IX, please click here. In this and the following two posts...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part IX]

How to apply Risk-based Thinking to Quality Processes - a Summary There are twelve posts in this series. To re...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VIII]

RISK MANAGEMENT METHODOLOGY FOR QUALITY MANAGEMENT Steps 4-6 in the method There are twelve posts in this seri...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VII]

There are twelve posts in this series. To read Part VI, please click here.  Steps 1-3 in the method If you hav...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VI]

  There are twelve posts in this series. To read Part V, please click here. Risk based thinking is the new 'pr...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part V]

SO 31000 Risk management techniques - continued Attributes of a selection of risk assessment tools   There are...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part II]

ISO 31000 Risk management techniques: A selection of risk assessment tools you might like to consider Part 1 i...

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Cyber Essentials: Why your organisation should 'Get Badged'! - Part V

Part V:  Requirements 4. Malware protection, and 5. Patch management Malware protection software is a necessar...

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Cyber Essentials: Why your organisation should 'Get Badged'! – Part IV

Requirement 2. Secure configuration, and 3. User access control The second Cyber Essentials Requirement refere...

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Cyber Essentials: Why your organisation should ‘Get Badged’! – Part III

Technical Requirements for Basic Protection from Cyber Attack Standardised approaches to cyber security will b...

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Cyber Essentials: Why your organisation should 'Get Badged'! - Part II

    Does Cyber Essentials involve any form of Risk Assessment? A question that I posed to BIS and GCHQ at the ...

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Cyber Essentials: Why your organisation should 'Get Badged'!

What is the Cyber Essentials Scheme - and will Business buy in? The Jury is assembling. What will businesses m...

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ISO27001:2013: What has changed from 2005? - Part III

Documentation Requirements set out in ISO/IEC 27001:2013 For those of you who are currently 'transitioning' to...

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ISO 27001:2013: What has changed? - Part II

  Information Security Risk Assessments in ISO/IEC 27001:2013 ISO/IEC 27001:2013 aligns with the principles an...

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ISO 27001:2013 - What has changed from the 2005 version?

  The short answer is 'A lot more than many professionals currently think'. To start, though, the basic facts:...

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Do You Trust Your Ex-Employees?

  It's one thing to ask whether companies truly trust their employees with company information, but I think mo...

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Virus-infected Office Macro threats and self-signed SSL certificates

  I saw an article today whose headline ("Remember macro viruses? Infected Word and Excel files? They're back....

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CogniDox and Information Security Management - a white paper

 

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Single- versus multi-tenant cloud architectures

A few weeks back the topic of single-tenancy versus multi-tenancy in cloud architectures was mentioned. I made...

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