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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...

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

Part I: Overview These days human life is touching Artificial Intelligence (AI) in one way or the other, for example, by searching for the next holiday destination over the internet, following Netflix recommendations on movies, asking Alexa if an umbrella is needed...

Computerised System Validation vs Computer Software Assurance by the Example of ERP System Validation

The pharmaceutical, biotech, and medical device industries are subject to strict health authority regulations to protect data integrity, product quality, and patient safety. Validation of computerised systems is crucial for nailing these three objectives. Life...