Oct 27, 2025
Step into the future of pharmaceutical and medical device innovation with Steve on The Life Science Effect. In this episode, Steve explores the transformative power of Pharma 4.0 and Validation 4.0, drawing insights from two thought-provoking blog posts by Robert Perks of Performance Validation. Discover how digital-first strategies, artificial intelligence, and continuous monitoring are reshaping compliance, quality assurance, and operational efficiency in life sciences. Steve breaks down the shift from paper-based systems to predictive analytics, highlighting the importance of aligning people, processes, and technology in a highly regulated industry. Whether you’re a new entrepreneur, engineer, or project manager, you’ll gain actionable takeaways on embracing digital transformation, collaborating with regulators, and staying ahead of industry trends. Tune in for key lessons, expert perspectives, and a call to action for leaders ready to drive change in pharma and medical devices. Keywords: Pharma 4.0, Validation 4.0, AI in life sciences, regulatory compliance, digital transformation.
BLOG POSTS MENTIONED:
Embracing Pharma 4.0 — A Strategic Imperative for a Digital-First Future - Performance Validation
MUSIC: Acid Jazz-Kevin MacLeod used under the Creative Commons Attribution 4.0 International License
TRANSCRIPT:
00:00:00
HOST: You are about to experience the Life Science Effect, Season
2, brought to you by our presenting sponsor, BPM Associates.
00:00:15
HOST: Extraordinary people.
HOST: Relationships that matter.
HOST: Important change for a better world.
HOST: The joy of belonging.
HOST: Life. Science. Leadership.
00:00:29
HOST (Steve): This is Steve, and it's time for another active
ingredient.
00:00:33
HOST: I thought for a minute about not calling this segment "active
ingredient" today because it's not just one article—it's two blog
posts. But it's still off the cuff. I’ve read these two blog posts
and I’m going to interview myself about them. Both are from the
website of a great company called Performance Validation.
00:00:54
HOST: Performance Validation is a compliance company. They do
validation services, commissioning qualification, building
commissioning, temperature mapping, computer system
validation—really involved in the nuts and bolts of our industry to
ensure processes and equipment run in compliance.
00:01:24
HOST: They’re a great company. Check them out at PERFVAL.com.
00:01:32
HOST: The two blog posts are by Robert Perks, Director of Digital
Solutions for Performance Validation. I don’t know Robert
personally, but I really enjoyed these posts. Maybe I’ll get to
know him someday.
00:01:52
HOST: The first is “Embracing Pharma 4.0: A Strategic Imperative
for a Digital First Future.” The second is “The Transformative
Impact of Artificial Intelligence on Validation in Life
Sciences.”
00:02:16
HOST: What caught my eye about these articles? If you heard a
recent episode where I talked about Industry 4.0, you know I
admitted I don’t really know what I’m talking about there. So these
posts caught my eye—maybe I can learn more about Industry 4.0 if
Robert is talking about Pharma 4.0 validation. He even uses the
term “Validation 4.0” in the AI article.
00:02:51
HOST: My first reaction was excitement. Pharma 4.0 aligns with
Industry 4.0 by connecting resources, information, people,
equipment, and software through digital systems. It aligns
organizations, processes, and culture with emerging technology.
00:03:24
HOST: Pharma 4.0 is actually a trademarked term by ISPE—the
International Society for Pharmaceutical Engineering. They’ve
broadened their scope to include computer systems and medical
devices, not just pharmaceuticals.
00:04:13
HOST: ISPE coined Pharma 4.0 to show how Industry 4.0 applies to
pharmaceutical manufacturing, development, and distribution. At a
high level, it’s about aligning resources, systems, organizations,
processes, and culture to fit our regulated environment, ensuring
quality and compliance while breaking down silos and moving away
from paper-based systems.
00:05:13
HOST: Now, we live in a paperless world. How do we align digitally
enabled processes to take full advantage?
00:05:31
HOST: Is this a big deal or just noise? It’s a big deal. Mr. Perks
points out this isn’t a future vision—it’s happening now. It
reminds me of the late 90s when computer systems started replacing
paper, and the FDA was asked how they’d regulate digital
records.
00:06:32
HOST: Now, there’s more collaboration between regulators and
industry, leading to optimal solutions. This is the right now, not
just the future.
00:06:55
HOST: The second post is “The Transformative Impact of Artificial
Intelligence on Validation in Life Sciences.” So, what is
validation?
00:07:09
HOST: Validation means proof that a medicine, device, or system is
fit for its intended use. Proof is evidence—often test results or
measurements.
00:08:17
HOST: In pharma and medical devices, validation means proving the
system, process, device, or medicine is fit for its intended
use—safe, effective, and reliable.
00:08:54
HOST: Historically, validation was retroactive: something happens,
a report is written, signed, and filed until an auditor reviews it.
If bad product was made, it might already be on the market, leading
to recalls and potential harm.
00:09:54
HOST: With Validation 4.0, we’re using AI and digital technologies
for continuous monitoring and testing. AI can analyze data streams
and alert us to issues before bad medicine is made—predictive, not
just reactive.
00:10:44
HOST: My company just brought on a new consultant with high-speed
manufacturing experience. Life sciences often lag in adopting
advanced manufacturing technologies, but Industry 4.0, Pharma 4.0,
and now Validation 4.0 are being embraced.
00:11:23
HOST: This is the future—and in some cases, it’s today. The next
four or five years will be transformative for our industry. I want
my company at the forefront, so I’m asking folks to read, listen,
try things out, and embrace technology.
00:12:18
HOST: I’d love to hear from others actually working in this space.
Someone smarter than me might say it’s easier than it looks, or
that we could go faster if we removed obstacles.
00:12:39
HOST: Check out these blog posts—I’ll link them in the show notes.
Let me know what you think. Is Robert Perks onto something? If you
have questions or want to see something addressed, let me know.
00:13:00
HOST: As always, you can reach me at
stephen.vincent@bpm-associates.com. Visit thelifescienceeffect.com.
Find us on all podcast platforms. Like, subscribe, do all the
internet things. Most importantly, take care of each other, stay
strong, and thanks for listening.