WHY A PHARMA-DEFINED SOFTWARE ARCHITECTURE BEGINS WITH GMP
The following conversation occurred on April 8th as part of the 2022 IoT Day Slam.
Ron Ricci: When you’re selling a breakthrough innovation to a B2B customer, rank order these considerations: technology, process and culture?
What’s most important and what has the least impact on the decision?
Ed Lau: Least impactful? I think I would say Technology. And most impactful — Culture.
Ron: (Laughs) Thank you for playing along Ed. When I worked at Cisco, John Chambers said this all the time — whenever you’re trying to drive breakthrough change with a new technology, you have to remember that the easiest thing to actually buy is the technology.
But the hardest things to change are the existing process that technology is going to impact, and maybe the culture where the people are working and have built a certain way of doing things.
Ron: Knowing how important culture and process are, let’s go back to the conversation — what is GMP?
Ed, earlier you said GMP is really about the safety and efficacy of drugs. I take three prescription medicines every day and I have been told by my doctor they don’t have side effects … and none of them have.
Somebody invented something and discovered something quite remarkable. Somebody approved it — the FDA. And then someone has manufactured it and built it, and that’s really where GMP comes in.
GMP is really those systems processes and procedures that make sure we can trust a drug is safe to consume?
Ed: Yes, absolutely. It defines a robust framework for safety and efficacy of drugs, yes.
Ron: So if you were at a software company, would you ever ask a Pharma company to change their GMP processes?
Ed: (Laughs) Absolutely not. I think the efficacy and quality of the drugs we find here in the US is in large part due to this robust framework that exists to maintain quality standards for drugs.
Ron: On that topic, I know I have personally learned so much in the Pharma Industry. What would you say Phizzle has learned about how we need to think differently for Pharma when writing software involved with GMP and the FDA?
Ed: A couple of things. The documentation which is necessary to be a part of GMP is extremely rigorous. It requires verification and validation, for example, the software. In the documentation and user manuals you also need to identify what happens when the software encounters an issue, and what remedial action would be.
Generally speaking, with consumer software, you see some of that. In the case of GMP-based software, it has to be rigorous and robust.
Ron’s Big Prediction:
I believe Good Manufacturing Processes (GMP) is the key to unlocking the next billion-dollar IOT opportunity.
*Conversation is edited lightly for clarity. Full discussion available here: