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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

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

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

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 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

Navigating IVD Device Regulations in the UK: Challenges for Developers

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

4 min read

Securing Virtual Collaboration: Risks and Solutions

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

3 min read

The Competitive Edge of ISO Certification: A Path to Success

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

5 min read

MHRA Guide: Remote Approval Requirements for Digital Signatures

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

4 min read

Common Pitfalls in Corrective Action Management: How to Avoid Them

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

4 min read

Mastering CAPA Management in the Medical Device Industry

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 Data Breach: A Lesson in Document Management

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

3 min read

Unleashing Organisational Knowledge: ISO 9001:2015 Requirements

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

3 min read

Integrating ISO 27001 and ISO 9001: A Guide for High-Tech Businesses

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

3 min read

Unlocking the Potential of DMS for Driverless Tech Development

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

4 min read

Navigating the Challenges of Med-Tech Quality Management

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

4 min read

The FDA's need for Quality Management in Medical Device Development

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

3 min read

Unlocking the Value of ISO Certification Beyond Compliance

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

3 min read

Securing Regulatory Compliance: The Power of Digital Signatures

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

Document Security in the Information Age: A Two-Pronged Approach

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

3 min read

The Rising Threat of Whaling: Protecting Your Organisation from Fraud

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

3 min read

Apply Risk-Based Thinking in ISO 9001:2015 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

Risk-Based Thinking in ISO 9001:2015 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

Risk-Based Thinking in ISO 9001:2015 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

Apply Risk-Based Thinking in ISO 9001:2015 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

Apply Risk-Based Thinking in ISO 9001:2015 Quality Processes - Part V

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

5 min read

Apply Risk-Based Thinking in ISO 9001:2015 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 Documentation Requirements: A Comprehensive Guide

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

5 min read

Understanding Changes in ISO 27001:2013 Risk Assessments- Part II

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

4 min read

Understanding the Changes in ISO 27001:2013

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

4 min read

Can You Trust Your Ex-Employees with Company Data?

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

2 min read

Beware of Virus-Infected Macros 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 Comprehensive Guide

2 min read