The latest news and updates from cognidox

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

ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...

Supplier management needs to be a collaborative and proactive process if it’s going to deepen key relationship...

Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...

The medical device development process is typically broken down into five distinct phases.  Each one requires ...

How much control do you have over the documents your business generates? How much do you need?

The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...

The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...

Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...

I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...

I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...

There’s plenty of document management and file-sharing software available on the market, but not all of it is ...

Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...

Colocation was one of the central tenets of the Agile manifesto, but times have changed. With all the new digi...

How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...

If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...

As your computer waits to load up Teams, Zoom, Slack, Accello and countless other collaboration apps every mor...

Will a phase gate process hold back or enhance your new product development? What are the pros and cons of sta...

Can product innovation really happen by accident? Penicillin, Viagra and the humble Post-It note were all famo...

Does your Document Management System (DMS) apply the five Lean principles to the way you work?

Companies often embark on business process modelling projects with the best of intentions. Modelling may be a ...

Change control in life science development is critical to ensuring the ultimate safety of end users. And havin...

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

For those who need ISO 9001:2015 certification, virtual audits are currently taking the place of face to face ...

Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...

In the history of product innovation, stories of happy accidents abound. The list of inventions stumbled upon ...

Remote collaboration is the new normal and set to be a major feature of the post-Covid world.  Workers have fo...

Choosing and installing a med tech eQMS is a resource and time-hungry undertaking. And the stakes are high. If...

Cambridge, UK, 18th Jan 2021: Cognidox, a leading provider of document management solutions for the medical de...

Would your business benefit from using electronic signatures within your digital quality management system (eQ...

The race for the development of a Covid-19 vaccine has been an incredible story of fast tracked innovation. Th...

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...

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...

  In a previous blog, we wrote that information findability is as worthy a topic for ISO 9001:2015 standards-m...

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...

The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...

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...

There are many reasons why an organisation might need to document their SOPs. From training staff and identify...

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 regulations and literature surrounding medical device development are packed with acronyms and technical t...

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 ...

Documenting your SOP (standard operating procedures) can be a drag. It can feel unnecessary for a relatively s...