October 23, 2018

Pharma 4.0 is here – we need to understand the compliance implications of big data and AI

Share this post

With Pharma 4.0 comes a paradigm shift in many aspects. We in the pharma industry know all too well that every move we make needs to consider compliance with regulation – it’s in everything that we do. Yet we can’t ignore the promise that these new technologies come with while at the same time speculating about the regulatory aspects.

Although it may seem overwhelming right now, we must change the way we think.  New technologies such as big data, artificial intelligence, machine learning, and deep learning offer unprecedented analysis of real-time data and can even predict trends in processes, operations, and quality. You probably have heard this many times before, but it is truer this time than before. The digital transformation technologies are really novel, different, and not something that we have seen before – they are disruptive. They promise manufacturers ways to understand and improve their manufacturing and bring about an order of magnitude productivity improvements, and the good news is that the FDA is also in on it.

So, new technologies, new terminology, maybe even new regulation? So much to take in and understand, so many questions – where is this cloud and why is the data big, and what about GMP? In an attempt to explain some of these concepts, technologies and the regulated perspective we recently published an article in the ISPE PE magazine. The article attempts to give a pragmatic approach to how we can use a cloud-based SaaS solution with an AI algorithm to support our pharma manufacturing operations and quality processes.

Note: ISPE member login required to see the article online. Let us know if you can’t access the article.