The latest news and updates from cognidox

Organizing Organizational Knowledge: the case for information management in ISO 9001 (Part 1)

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

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Bionic pigs are not enough. How to win med-tech investment if you're not Elon Musk

When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...

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Knowledge or noise? Managing your company’s structured & unstructured data

Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...

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The 5 Pillars of GMP in the Pharmaceutical Sector

For pharmaceutical and other life science disciplines, the ‘5Ps of GMP’ are a useful way of thinking about the...

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QSR Compliance: What’s inside FDA 21 CFR Part 820?

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

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Why document review is critical to successful new product development

Inadequate document review is often to blame for failure in new product development and manufacturing processe...

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GMP v cGMP. What's the difference?

GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...

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Medical device audits: what, when, how and who?

Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...

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How Lean Documentation Creates Customer Value In The Development Cycle

In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...

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