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Top 5 GxP Controls

The quality and safety of a product have always been one of the biggest concerns in the pharmaceutical industry. To address this,  GxP was established and its compliance is mandatory in the healthcare environment. The GxP is a generic term, where ‘G’ stands...
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Can the Use of Unlicensed Font on your Website, Marketing Materials, or Packaging amount to a Copyright Breach?

"Type designers are, at their best, the Stradivari of literature: not merely makers of saleable products, but artists who design and make the instruments that other artists use." ― Robert Bringhurst  A good webpage and marketing...
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What is and what is not a Software as Medical Device (SaMD)?

The pandemic lockdown has sped up digital transformation in this era. It is increasingly accepted that the availability of certain mobile or web-based apps have helped medical personnel better handle their jobs and allowed patients to access medical information or...
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Agile and Scrum in GxP Environments – How does it Work in Practice?

“Intelligence is the ability to adapt to change.” (Stephen Hawking) Introduction To date, classical methodologies, such as Waterfall or V-model, are standard practices. But Agile frameworks like Scrum are lately gaining more and more popularity. Several big companies...
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