At a recent knowledge sharing and networking event in London, England, life science industry professionals gathered to glean insights from experts on the common...
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Survey says: Proactive quality risk management for life science companies is a must
Klavs Esbjerg, CEO and founder of Epista Life Science, is on a mission to help his clients continuously improve regulatory compliance and in turn, transform their...
Why digitised design control is essential for the sustainability of your DHF
Thanks to Laurence Sampson for writing this article, as a preview to the upcoming conference on Practical Solutions in CSV and SDLC for GXP & MedDev (London,...
The difference between data integrity & data quality in medical technology companies – and why you must care
Data is the lifeblood of any Life Sciences company - and trust is the heart. For those of us that manage data, we cannot and will not allow drugs or medtech devices to...
How paperless validation assists pharma success
Why should I implement paperless validation For many of the medtech and pharmaceutical companies I consult, there’s a common clash of the validation systems “worlds”...
Stuttgart Summit: Highlights & takeaways on how to validate software development tools for GXP and MedDev
Last week a select group of 15 health sector professionals representing businesses from startups to large pharmaceutical companies gathered in Stuttgart, Germany for...
Risk analysis for computerised systems
When done correctly, risk analysis can help to identify things that could go wrong in a process once it has been put into action. It may also trigger creative thinking...
When does a software tool require validation?
If a software tool is used for any process that affects product or quality systems in a regulated sector like life sciences - pharmaceuticals, medical technology or...
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