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In Part 1 of this series we considered the problem of reinvention, the unstructured nature of information, and...
In Part 1 of this series we considered the problem of reinvention, the unstructured nature of information, and...
Throughout the med-tech regulatory literature quality systems are cited as the way GxP (current best practice)...
If you’re not planning to improve your operational resilience, you’ve not been paying attention. How can a dig...
In a previous blog, we wrote that information findability is as worthy a topic for ISO 9001:2015 standards-mak...
When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...
Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...
For pharmaceutical and other life science disciplines, the ‘5Ps of GMP’ are a useful way of thinking about the...
Inadequate document review is often to blame for failure in new product development and manufacturing processe...
GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...
In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...
It’s much easier to screw up a new product development process than mastermind a successful one. Here’s how.
cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science ind...
Research shows one of the key challenges for life science companies is balancing the need for rapid innovation...
The outlook for many companies might be unpredictable at the moment, but access to the right document manageme...
The US human interface company, Snyaptics Inc announced this week that they are acquiring DisplayLink Corp in ...
Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...
There are five stages of document control critical to NPD and product management. If you have the digital tool...
Last week, news broke that Siemens is acquiring the Cambridge based company and Cognidox client, UltraSoC, in ...
The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...
There are four entities defined under the EU MDR and IVDR as “economic operators”. Under the regulation, these...
Cambridge, UK, 22 May 2020: Cognidox, a leading provider of document management solutions for the high-tech, m...
A brief internet search will confidently tell you that there are anywhere between 4 and 8 stages of the ‘ideal...
A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...
Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....
For medical device developers assembling and presenting all the required documentation for the DHF (Design His...
There's a long-running debate whether a bug or defect tracking software tool is just a synonym for a help or s...
One of the things Covid-19 has shown us, is that the digital agility of an organisation can mean the differenc...
There are many file sharing apps on the market right now. They range from ‘free’ or ‘low cost’ one size fits a...
Developing a robust stage gate process is a vital part of many new product development (NPD) and introduction ...
ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action ...
For most high tech companies, developing profitable new products is their entire reason for being.
One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is: ...
The third edition of ISO 14971 (Application of Risk Management to Medical Devices) was released in December 20...
Many organisations still operate without a central, shared Document Management System (DMS) that effectively m...
Cognidox’s commitment to improving usability and cross platform accessibility continues with the release of v1...
If you took a snapshot of document management around 20 years ago, the general situation was that in my indust...
Managing an NPI process can be fraught with difficulty as each new initiative brings with it the potential for...
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...
Cognidox’s story is bound up with that of the "Cambridge Phenomenon" the so-called Silicon Fen high-tech clust...
There’s no shortage of words in print and online written by regulators, consultants and software developers ab...
The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledg...
What should come first in a med tech project? Product development or documentation?
Companies working in heavily regulated sectors might have been historically slow to change and optimise their ...
Companies are often spurred to undertake business process mapping to improve their quality management.
How do you need your product management process to function? A classic article in the HBR got us thinking abou...
As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...
The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...
Many high tech businesses who are implementing a Quality Management System (QMS) to gain ISO 9001:2015, are in...
In 1969 quality management was truly the final frontier in the space race. As NASA engineers developed unique ...
A change control process is a vital part of any product development and management function. But if it’s not e...
Advanced Driver Assistance Systems (ADAS) and even driverless cars, once the stuff of science fiction, are rap...
A responsive new product development (NPD) process has always been a key part of a high tech business strategy...
Can you ever make a stage-gate process Agile? Can modern tools and a hybrid approach to Waterfall and Agile br...
Not all business management software solutions are created equal. They come in different shapes and sizes, wit...
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