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In clinical trial management two sets of documents are essential to success: the Trial Master File (TMF) and t...
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In clinical trial management two sets of documents are essential to success: the Trial Master File (TMF) and t...
Q-Pulse (by Ideagen) is a long-standing quality management system used across pharma, aviation, and life scien...
EU Annex 11 provides guidelines for the use of computerised systems in ensuring Good Manufacturing Practices (...
Post-Brexit, there is still confusion about the future use of the UKCA (UK Conformity Assessed) markings and w...
It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...
Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...
How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...
Data integrity is central to the safe development and manufacturing of every life-science product on the marke...
Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure th...
ISO 9001 and ISO 13485 are both internationally recognised quality standards, but they serve different industr...
IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...
Last year, Slack, Zoom and countless other companies hoovered up business as companies shifted to support new ...
The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...
A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...
ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action ...
Mastering CAPA management is part of the proactive quality mindset that regulators demand, but it is also an a...
We’ve all been there, haven’t we? We’ve all accidentally published online the addresses of hundreds of celebri...
The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledg...
Many high tech businesses who are implementing a Quality Management System (QMS) to gain ISO 9001:2015, are in...
Advanced Driver Assistance Systems (ADAS) and even driverless cars, once the stuff of science fiction, are rap...
Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...
Reports from the U.S. tell us the FDA is continuing to prioritise Proactive Quality Management in the medical ...
Is ISO certification the only reward you’ll receive for jumping through all those QMS hoops? And is it really ...
For companies operating in highly regulated sectors like medical devices, biotech, and pharma, digital signatu...
Cambridge, UK, 1 August 2018 - Cognidox, the leading provider of document management solutions for the high-te...
Most people think of document security only in relation to highly sensitive documents. However, the security o...
The CEO, CFO, COO of a company: the people in charge, the brains behind the whole organisation. If not totally...
How to apply Risk-based Thinking to Quality Processes - a Summary There are twelve posts in this series. To re...
RISK MANAGEMENT METHODOLOGY FOR QUALITY MANAGEMENT Steps 4-6 in the method There are twelve posts in this seri...
There are twelve posts in this series. To read Part VI, please click here. Steps 1-3 in the method If you have...
There are twelve posts in this series. To read Part V, please click here. Risk based thinking is the new 'prev...
SO 31000 Risk management techniques - continued Attributes of a selection of risk assessment tools There are t...
ISO 31000 Risk management techniques: A selection of risk assessment tools you might like to consider Part 1 i...
Documentation Requirements set out in ISO/IEC 27001:2013 For those of you who are currently 'transitioning' to...
Information Security Risk Assessments in ISO/IEC 27001:2013 ISO/IEC 27001:2013 aligns with the principles and ...
The short answer is 'A lot more than many professionals currently think'. To start, though, the basic facts: I...
It's one thing to ask whether companies truly trust their employees with company information, but I think most...
I saw an article today whose headline ("Remember macro viruses? Infected Word and Excel files? They're back......
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