More about our sector?

this is your place

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

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

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.

Melissa Villalobos

Sales and Marketing Coordinator

Bigfinite Announces Additions to Executive Team

Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that Brian Sweeney, Lawrence Baisch and Glenn Griffin have been added to the leadership team.
Crystal Black VP of Marketing

AI Algorithm Qualification

Pharmaceuticals and Biotech companies have no doubt that Artificial Intelligence (AI) is here to stay. Nonetheless, the opportunities AI technology offers are developing at a slow pace in a rather conservative manufacturing industry, aimed at managing production risks under controls that are subject to strong regulations. Fear of change? Risk aversion? Likely not.
Jordi Guitart VP of Artificial Intelligence

Bigfinite Announces Senior Leadership Additions

Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that John Vitalie has been named Chief Executive Officer (CEO) and has been elected to the Board of Directors. David Merino has been named Chief Financial Officer (CFO) of Bigfinite.

Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

Technological Enhancements with Principal Component Analysis Combined with Artificial Intelligence

Bigfinite Closes Series B Financing with Atlantic Bridge and Honeywell Ventures to Drive Disruption in Manufacturing Analytics

2019 Xavier University AI Summit Reflections – Two Industries Ready for Change

Now that the dust has settled from the Xavier University AI Summit and our team is back to business, we’ve had time to process some of the highlights and key takeaways from the exciting event.  In the past few years, there has been a significant increase in the implementation of digital technologies into various industries that subsequently impacted the way we live, travel, and do business.  From driverless cars to 24/7 customer support chatbots, innovation and technology continue to spiral upward and as we’ve entered the 4th industrial revolution, and healthcare + biopharma should be no exception.  The Xavier University AI Summit is a great event that brings together a range of relevant stakeholders with common focus on artificial intelligence (AI).

Bigfinite and NNE Partnership

Bigfinite and NNE announced a strategic partner program agreement to collaborate around accelerating digital transformation within manufacturing operations at the world's leading pharmaceutical and biotech manufacturers. 

Where are Pharma Companies in the Age of Artificial Intelligence?

They say good things come to those who wait; we say good things come to those who wait but only the things left by the visionaries before them.  The pharmaceutical industry has long been known to lag in the adoption of new technology due to strong regulations. Even though regulators have recently begun to open up to several new ‘big data’ or pharma 4.0 technologies - the question remains, if pharma companies are doing the same?  In 2016, the European Pharmacopoeia 9.0 in Chapter 5.21 announced that neural networks (NN) and support vector machines (SVM) are valid chemometric techniques for processing analytical data sets. 

Data Scientist 4.0 – Bridging the World of Manufacturing and Data

Since the announcement of the 4th Industrial Revolution in 2011, multitudes of emerging technologies have transpired around “Industry 4.0”. Technologies such as digital twins, Industrial Internet of Things (IIoT), and cyber-physical systems have come into the scene as core elements, providing the necessary ingredients for a paradigm shift in manufacturing. Technologies around predictive analytics and artificial intelligence are pioneering new approaches with many use cases including predictive maintenance, autonomous process optimization, and pattern recognition - used to identify potential failures in real-time. Because of this, data science is becoming an invaluable discipline for our industry in order to transform information into knowledge.