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Data integrity in life sciences: the vital role of ALCOA principles

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

5 min read

Corrective action: why, when and how?

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

6 min read

Calibration of equipment 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

A short guide to non-conformance reports; what, why and how

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

5 min read

ISO 9001 vs ISO 13485. What’s the difference?

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

4 min read

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...

4 min read

How secure is your virtual collaboration process?

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

3 min read

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 -...

5 min read

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...

4 min read

Why corrective action management goes wrong

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

4 min read

What is effective CAPA management?

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

4 min read

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...

3 min read

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...

3 min read

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...

3 min read

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...

4 min read

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...

4 min read

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 ...

3 min read

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 ...

3 min read

How digital signatures can help secure regulatory compliance

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

3 min read

Cognidox achieves full iSO 27001 certification

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

2 min read

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...

3 min read

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...

3 min read

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...

10 min read

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...

9 min read

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 have...

9 min read

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 'prev...

9 min read

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 t...

5 min read

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...

7 min read

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...

5 min read

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 and ...

4 min read

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: I...

4 min read

Do You Trust Your Ex-Employees?

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

2 min read

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......

2 min read

CogniDox and Information Security Management - a white paper

2 min read