My original title for this blog was...Challenging the Old Guard: Why Dismissiveness Has No Place in CSV/CSA Conversations (Or: How I Learned to Stop Worrying and Love the Risk Matrix) as usual I will poke the bear. It also makes be think of an article I wrote years ago, after reading George Lakoff's Don't Think of an Elephant!
So Let's talk about the elephant in the validation room, the one wearing a vintage GAMP 5 t-shirt and clutching a three-ring binder like it's 1999.
For decades, Computer System Validation (CSV) has been our North Star in regulated industries. The FDA's General Principles of Software Validation (2002) and GAMP 5 were never about creating paper monuments to bureaucracy. They were always risk-based at their core, asking us to apply actual science, critical thinking, and (gasp!) proportionality.
Here's the plot twist: CSV has always been about risk. What's evolved isn't the principle, it's our ability to actually measure and manage that risk without drowning in documentation. Whether we're validating a coffee maker in the break room (kidding... mostly) or software as a medical device, today's landscape would make our 1990s predecessors' heads spin. And that's exactly the point.
That's the beauty of the regulatory system: it gives us frameworks, not rigid recipes. It pushes us to continuously evolve with science and technology while never losing sight of product quality, patient safety, and data integrity.
Or at least, that's what it's supposed to do.
The Problem: Death by a Thousand "Actually..."s
Recently, LinkedIn has become a battleground where seasoned professionals deploy tactical "actually"s and strategic eye-rolls whenever someone under 40 mentions CSA. Words like "rubbish" and "clearly you haven't read the guidance" fly like validation grenades.
When seasoned experts dismiss new perspectives instead of engaging with them, we don't strengthen our field, we weaken it. We risk creating an echo chamber where only the loudest voices are heard, and where innovation goes to die in a committee meeting.
News flash: Gatekeeping isn't a validation strategy. When we dismiss instead of discuss, we're not protecting the field, we're turning it into a museum exhibit titled "Things We've Always Done This Way."
The Dialectical Dance: When Both Sides Are Right (And Wrong)
Here's where it gets spicy.🌶️🌶️🌶️ The CSV vs. CSA debate is a perfect example of dialectical thinking, where two seemingly opposite truths can coexist:
Thesis: "CSV has always been risk-based!" (The old guard, probably adjusting their reading glasses)
Antithesis: "But CSA brings fresh perspective and modern approaches!" (The new generation, definitely on TikTok)
Synthesis: Both are right. CSV was always intended to be risk-based, but CSA emerged because too many organizations turned it into a paper-pushing exercise that would make Kafka weep.
The beauty of dialectical thinking? It lets us hold space for complexity instead of picking teams like we're at a validation Super Bowl.
Did the FDA Spend Six Years on a Regulatory Prank?
Let me get this straight, do we think the FDA, an agency that moves at the speed of continental drift, spent SIX YEARS developing CSA guidance as... what? An elaborate practical joke? A marketing stunt?
FDA Meeting, Year 3: "Should we work on that drug shortage crisis?" "Nah, let's keep wordsmithing this validation guidance to mess with people."
Come on. The FDA created CSA because they were tired of seeing companies validate their validation of their validation documentation. They wanted us to think, not just document our way to compliance nirvana.
The guidance exists to:
To dismiss this as "marketing" not only disrespects the work regulators put in, it sends the wrong message to the next generation: that guidance doesn't matter and change is the enemy.
Let's Talk Numbers: Quantitative Risk Management (Because Math Doesn't Lie)
Here's what many miss in the CSV/CSA conversation: modern risk management isn't about gut feelings or "because I said so." It's about actual, quantifiable risk assessment:
Traditional Approach: "This system is critical, so we'll do EVERYTHING." Translation: Risk Score = ∞
Quantitative Approach:
See the problem? We've been treating every system like it's handling plutonium when some are just tracking office supplies.
Consider this risk matrix evolution:
The Mathematical Reality Check:
The numbers don't lie. We're often solving for X when X stopped being a variable years ago.
Risk Tolerance: It's Personal (And That's the Problem)
Here's the uncomfortable truth: Risk tolerance is like spice tolerance, deeply personal and often projected onto others without consent.
Every professional brings their own interpretation of risk, shaped by their comfort level, bias, and past trauma from that one audit in 2015, and that directly influences how validation is executed. When those individuals sit in positions of authority, their personal risk tolerance often becomes organizational culture.
When "Bob" from Quality decides every system needs 47 test scripts because "that's how we've always done it," that's not regulation, that's Bob's anxiety manifested as policy. And suddenly, Bob's risk neurosis becomes company culture, passed down like a cursed heirloom.
This is why some manufacturers validate cleaning, product, and peripheral applications with a "one-size-fits-all" rigor. Not because regulations demand it but because someone's personal risk threshold set the tone, and it was perpetuated by people too afraid to ask "why?"
The old guard often says "CSV has always been risk-based", and they're right. But then we must ask: Why did so many organizations drift into burdensome, check-the-box validation?
The answer isn't in the regulations. It's in people's risk tolerance and the biases that got institutionalized.
Lessons from StarWest (Or: When "Quality" Met "Quality" and Nobody Recognized Each Other)
This isn't just a regulated-industry problem. But here's where it gets absolutely ridiculous.
Last week at #StarWest in Anaheim, I watched something beautiful and absurd unfold. Software engineers from every industry proudly called themselves "Quality" professionals. They wore it like a badge of honor. Software Quality Assurance. QA. Testing. Quality Engineering.
Meanwhile, I'm sitting there knowing that if I brought these same talented people to a pharma validation conference, half the room would clutch their pearls at the suggestion that what they do is "merely" Software Quality Assurance.
"We're Validation Engineers!" "We do Computer System Validation!" "We're in Quality, but not THAT kind of Quality!"
Friends, we've created our own caste system where we're too fancy to admit we're doing... checks notes... software quality assurance.
Here's the kicker: These "mere" QA engineers at StarWest? They're achieving higher quality metrics with automated testing, continuous integration, and risk-based approaches that would make our 500-page validation plans look like we're compensating for something. Which we are. Our insecurity.
One engineer showed me their entire quality framework, fully automated, completely traceable, with real-time risk dashboards. Time to complete: 2 hours. Our equivalent validation package? 2 months and a small forest worth of paper.
When I explained that in my world, some validation engineers would be offended to be called Software QA, the response was a long pause followed by: "But... that's literally what you're doing? Just with more documents?"
The Dialectical Identity Crisis:
The Great Acronym Apartheid:
We've somehow convinced ourselves that:
It's the same work, people! We're all making sure software doesn't kill anyone, steal data, or accidentally order 10,000 units of the wrong thing. The only difference? Their "bugs" don't get FDA warning letters.
But here's the thing — sometimes their bugs are WORSE. When their software fails:
Yet somehow, these QA engineers manage catastrophic risk without generating a validation package that could double as a doorstop. They use something we've apparently forgotten exists: discernment.
My point is NOT that every application has direct impact to patient safety. That's exactly the orthodoxy that got us here! You need to be able to apply discernment — to look at a system and say "this tracks office supplies" versus "this controls drug dosing" and validate accordingly.
The unregulated world gets this. They don't treat a marketing website like it's air traffic control software. But in our world? We'll validate that office supply system like it's managing nuclear launch codes, because someone, somewhere, once said the magic words: "GxP system."
At the heart of software quality, regulated or not, is always the same principle: Does the system do what it's intended to do?
Many of those engineers would be flabbergasted at the mountains of paper still produced in regulated organizations under the belief that more documentation equals more validation. It doesn't. It never has.
Over the past 30 years, and exponentially in the past 6 months, digital tools and digital testing have transformed the landscape. If you're not being curious, if you're not asking questions, you are already behind.
And here's where I'll add a bit of self-awareness: I was skeptical in the beginning too. I've been in this field long enough to remember thinking, "Isn't this just old wine in a new bottle?" But over the last several years, I've come to see the value in helping organizations discover their "Big Why", the core reason behind their validation choices. That's what keeps me curious and leading the way. If I can change my lens, so can you.
The Call to Action (With Actual Actions)
The FDA didn't spend six years telling us to think differently just so we could keep doing the same thing with new acronyms. They're begging us to evolve. The question is: Are we brave enough to do the math, embrace the dialectic, and actually change?
To the old guard: Your experience is invaluable. Your dismissiveness is not. Try this dialectical exercise: Next time you want to say "that's not how we do it," ask "what if we could do both?" Move beyond defensiveness. Model curiosity. Reflect on your own risk bias. And for the love of all that is validated, stop treating Software QA like it's beneath you, they're eating our lunch on efficiency.
To the new generation: Bring the data. Show the math. Respect the scars of those who've been audited. But don't back down from innovation. And when someone tells you "we don't do Software QA, we do Validation," smile and nod. Then show them your automated testing suite.
To everyone: Risk is measurable. Opinions are not validation strategies. And if you're still printing validation packages in 2024, we need to talk.
Because here's the synthesis we need: Experience + Innovation + Actual Math + Humility = Modern Validation
The next generation is watching. And leadership is not about shutting doors it's about leaving them open wider than you found them. Even if that means admitting we're all just doing quality assurance with different acronyms.
P.S. — To all your "Bob's" from Quality: It's okay to let go of the three-ring binder. I promise the validation police won't come for you. Probably. And yes, you're doing Software QA. We all are. And that's actually pretty cool when you think about it.