19 — 21 September 2022
The pharmaceutical industry as a whole (including the rapid development of new vaccines) is heavily regulated and competitive at the same time. The regulatory issues and its high risk products make it often the leader among manufacturing industries in adopting new technologies which then bring new regulations. US FDA Title 21 CFR Part 11 (1997-) is the most famous example of the now globally accepted code of regulations on electronic records and electronic signatures. And right now, moving from electronic towards digitalized metrology brings a whole new set of possibilities and challenges to GxP guidelines, ALCOA, and relevant data that has huge impact on product quality and patient safety. Especially important part of that is data integrity, and the main challenge is how to fulfill requirements to be compliant and produce data relevant for making quality decisions.
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