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The Grand Promise of Small Molecules

A continued trend in novelty saw the FDA (Food and Drug Administration) approving many structurally innovative drugs in 2020.    Powerful innovation of new drugs, biological products, and medical care usher in the promise of new and better treatment options for...

The Applicability of FDA’s Computer Software Assurance Guidance to Data Integrity

As technology progresses, new approaches to software inspection continue to be found. In the webinar ‘Understand the Applicability of FDA’s Software Assurance Guidance to Data Integrity’ (linked below), a new approach to validation is introduced. Computer Software...

Taking Shape: Artificial Intelligence Regulation and its Impact on CSV/CSA (III)

Part III: Overview   Overview of CSV for AI-based systems Artificial Intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. AI-based systems are software systems with functionalities enabled by at...

Taking Shape: Artificial Intelligence Regulation and its Impact on CSV/CSA (II)

Part II: Overview In the previous article, we discussed that AI has great potential to revolutionise the healthcare sector by deriving brand new insights from the data pool. Patients require protection from the elimination of bias built into algorithms, defective...
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