Table 3 Impact of Industry 4.0 on... | Emerald Publishing

Table 3

Impact of Industry 4.0 on regulatory compliance

“If you are talking about a Regulatory Compliance impact perspective, that does not come into the equation. None of what we are doing will impact any of that. You are making the product so that it is less likely to have a quality impact. I suppose one of the key things that can be said about Industry 4.0, I suppose, is that you reduce the amount of risks by taking out human error. So, by automating these processes and having these systems talk to each other over the network as opposed to having people manually enter values, you reduce the risk of error. So, on reflection, this improvement positively impacts compliance.” (P1)
“From the perspective of the Pharma or heavily regulated industries, the big challenge would be the speed at which you can roll Industry 4.0 out. Because any change you make to a system would have to be validated, or you have to ensure that you are not impacting a validated system when rolling it out.” (P5)
“I think EBR is maybe an example of where we put in a system to try and help improve compliance. So today, as you know, right, you get a batch manufacturing record where you have all the paper, and you know, you follow the paper in sequence, and you fill it out as you go. Now if somebody chooses to, they do not need to be contemporaneous in how they fill it out. Everybody should be Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) compliant. But in reality, when you finish the paper document, nobody knows the sequence you filled it out in. When you put in an EBR, EBR steps you down in a sequence. So, it will say do this, and then you do that, and then it will say do this, or it will say do a group of things. And so, from an ALCOA point of view, it helps” (P7)
“But the regulators have already embraced Industry 4.0, and even that is reflected in the training of and the types of personnel that they are hiring. They are hiring in the knowledge that we are in an Industry 4.0 environment. Thus, with them, they are coming to audit us, and some of those auditors are even well ahead of us in their knowledge. Moreover, we are worried about what are they asking.So, this is not a new adventure; some industries are much further ahead than others. We in this company are behind the curve and must catch up.” (P11)

Source(s): Authors’ own work