By Magnus Jahnsson, Principal Consultant, Epista Life Science
Validation is expensive, time-consuming – and, let's be honest, often frustrating. But in my 30+ years working in GMP-regulated industries, including qualification and validation, I've seen how a clearer, risk-based approach can improve efficiency. That's where ASTM E2500 comes in.
It's a standard that lets you outsource design and documentation, focus on what matters, and – when applied right – get your system into use faster – but only if you apply the standard correctly.
ASTM E2500 replaces the traditional DQ–IQ–OQ–PQ sequence with a more flexible, risk-based mindset.
Instead of treating everything as critical, it asks: "What actually affects product quality?"
Then you can separate requirements into two groups: critical aspects and supporting ones (good engineering practice). And it gives you flexibility in terminology. As I often say:
Verification is a flexible umbrella term. You don't have to use the terms DQ, IQ, OQ, PQ – only prove equivalence with them.
On paper, that sounds like a clear improvement. In practice, many teams struggle to break free from traditional habits – and that's where the problems begin.
They don’t dare to rely on the supplier’s competence. They redo all verifications in-house. They validate what doesn't need to be validated. And sometimes they assign critical tasks to junior staff who lack the experience to challenge documentation or design decisions.
As validation often sits at the end of a long process, everything that was swept under the carpet will come to the surface causing stress and costly last-minute problem solving, when all you should have to do at that stage is to verify functionality.
So, where should you start if you want to move from traditional validation to the E2500 mindset? There are three key areas to get right:
Start by defining what's critical. Use your R&D risk assessments to guide the depth of verification. Not everything needs the same treatment.
A mature supplier with a strong QMS can handle a lot of the work – if you've qualified them properly. You still review. You still take responsibility. But you don't have to replicate all the FAT and SAT-tests they do.
I like to challenge our clients by saying: We should be more like Star Trek. We should boldly go where no one has gone before – not always wait for others to go first.
Start with a minimal URS focused on critical aspects. Link it to risk. Then verify against it. You don't need endless protocols – you need justification and a clear line of logic.
Let’s translate the principles into a real-world scenario.
Theory is one thing, practice another. So let's look at how this works using a real example:
We worked with a large pharma company. Rather than writing a very long URS, they trimmed it to just a few pages – focused only on critical aspects. The supplier ran FAT and SAT under their own QMS. They reviewed the suitability of the test documentation, performed minimal internal testing where the supplier’s results couldn’t be leveraged, and tied it all back to the risk-based URS.
The outcome delivered what they aimed for:
regulatory acceptance, significant time savings, and QA oversight maintained throughout the process. This is what I call the aggressive model.
You can compare it to a more conservative approach where more testing is duplicated and a more conservative nomenclature (DQ, IQ, OQ) is used. Both can be compliant – it depends on your context.
Even with good intentions, applying ASTM E2500 isn't always straightforward. Many teams stumble on the same hurdles.
The approach works best when you use suppliers with solid technical knowledge and mature quality systems – combined with Subject Matter Experts who provide oversight based on a focused URS.
It struggles when teams treat changes to legacy systems like greenfield projects, place blind trust in weak suppliers, or push validation responsibilities to junior staff without proper guidance.
The difference often comes down to experience – knowing when to trust, when to verify, and when to dig deeper.
ASTM E2500 isn't a silver bullet. Validation will always require effort. But if you apply the standard with focus, experience, and smart supplier collaboration, you can reduce complexity – and still meet every regulatory expectation.
In short: ASTM E2500 works when you have the right foundation and approach.
At Epista, we help companies apply ASTM E2500 in a way that actually works – not just in theory. If you're ready to rethink your approach to qualification and want a practical way forward, let's start the conversation.
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.
