You implement clinical trial software, you get validation documentation. Job done, right?
Not even close.
Here’s what actually happens: you’re mid-implementation and gaps appear in the validation package, your QA team asks questions you can’t answer, auditors want to understand methodology and testing details that aren’t documented, and you end up filling gaps yourself and crossing your fingers that everything holds up under scrutiny.
This isn’t your fault; it’s an industry-wide problem where vendors deliver documentation but not the support infrastructure that makes that documentation actually useful. Let’s talk about what you should be demanding instead and why it matters for every software implementation you do.
The Validation Support You’re Not Getting (But Should Be)
Most software vendors treat validation documentation as a checkbox exercise, here’s the URS, here’s the FRS, here’s the IQ/OQ/PQ, and good luck. But documentation without context, guidance, and transparency isn’t validation support, it’s just paperwork.
Here’s what comprehensive validation support actually looks like and what you should expect from every vendor you work with:
Documentation Developed By Specialists Not Generalists
Your vendor’s product team shouldn’t be writing your validation documentation. Computer system validation is a specialised discipline that requires people who do this full-time and understand the nuances of GxP environments.
When specialists write validation docs, you get thoroughness that covers edge cases, methodology that stands up to audit scrutiny, and risk assessments that actually reflect real-world implementation scenarios.
Ask your vendors: who writes your validation documentation? Is it someone whose entire job is computer system validation, or is it someone on the product team doing their best?
Guidance That Helps You Actually Implement
Documentation is useless if you can’t explain it to your QA team or present it confidently to auditors. Comprehensive validation support means having access to experts who can help you understand what the documentation means, how it applies to your specific environment, and what questions auditors are likely to ask.
This isn’t just nice to have, it’s critical when you’re trying to get software implemented quickly without taking shortcuts on compliance. The difference between having guidance and not having it is the difference between confident implementation and crossing your fingers.
Ask your vendors: What happens when I have questions about the validation approach? Do I get access to the people who created it, or am I on my own?
Complete Transparency On Validation Activities
Black box validation is a compliance risk, you need to know exactly what validation work took place, what methodology was used, what testing was performed, and why decisions were made the way they were. When auditors start asking detailed questions about your validation approach you can’t afford to say “I don’t know, that’s what the vendor gave us.”
Transparency means you can trace every requirement back to testing, understand the rationale behind risk classifications, and explain the validation strategy to anyone who asks. This is what separates adequate documentation from documentation you can actually defend.
Ask your vendors: Can you explain your validation methodology in detail? Can I see evidence of testing activities? Do I understand why you made the decisions you made?
Validation That Adapts To Your Specific Needs
Generic validation packages don’t account for your specific use case, your unique regulatory requirements, or your particular GxP environment. When you implement software, you shouldn’t be trying to shoehorn your needs into someone else’s template; the validation approach should flex to match your reality.
This matters because no two implementations are identical. What works for a small biotech implementing basic vendor management might not work for a global pharma sponsor with complex SOPs and multiple regulatory jurisdictions. Adaptive validation means the strategy evolves with your needs.
Ask your vendors: what happens when my implementation doesn’t match your standard documentation? Can you adapt the validation approach, or am I stuck with what you’ve already built?
Why This Matters Beyond Just One Vendor
Understanding what comprehensive validation support looks like changes how you evaluate every software vendor you work with. It gives you a framework for assessing whether you’re getting adequate support or just adequate documentation, and there’s a massive difference.
When you know what good looks like, you can demand it. When vendors know you’re demanding it, they have to raise their standards. This is how the industry gets better, one informed buyer at a time, who refuses to accept documentation without the support infrastructure that makes it actually useful.
How We’re Delivering This Standard With DQA
We’ve partnered with Digital Quality Associates because we wanted to demonstrate what comprehensive validation support should actually look like, not just tell you about it.
Matt Jones founded DQA, with nearly a decade of computer system validation expertise, that expertise is now embedded directly into every Mayet solution we deliver, compliance thinking shapes how we build software from day one, not bolted on afterward, and every client gets access to the guidance, transparency, and adaptive validation approach we just described.
Here’s what this means in practice:
For Mayet Vendor Management Software: validation documentation developed by specialists who understand vendor management systems in GxP environments, not generic CSV templates, backed by guidance throughout implementation.
For TrialTrack: comprehensive validation packages with complete transparency on methodology and testing, supported by expert consultation when you need it.
For AI as a Service: validation documentation that addresses the unique regulatory questions AI raises in clinical trials, with depth and transparency that comes from having specialists embedded in the development process.
As the regulatory landscape becomes more complex around AI, cloud systems, and data integrity, having embedded validation expertise positions you ahead of the curve rather than scrambling to catch up.
For Bespoke Software Development: validation strategies designed alongside the technology with complete transparency on methodology, testing, and compliance approach, adaptive from the start.
Tom from Mayet and Matt from DQA meet monthly to ensure every client engagement has comprehensive validation support from the beginning, all validation documentation stays with Mayet, so you have permanent access with full transparency on what was done and why.
Want to see something we already built with DQA?
Check out our GXP computer system assessment form and start learning what validation requirements really are for all your systems:
Use This As Your Benchmark
Whether you implement Mayet software or not, use this partnership as your standard for what comprehensive validation support should look like with every vendor you work with.
When you’re evaluating software, ask these questions:
- Who develops your validation documentation, and what are their qualifications?
- What guidance do I get when I have questions about the validation approach?
- Can you explain your validation methodology and show me evidence of testing?
- How does your validation approach adapt to my specific needs?
- What happens six months after implementation when I have an audit?
The pharmaceutical industry shouldn’t face a choice between innovation speed and regulatory confidence. Through this partnership, we’re proving they can have both.
Matt jones
What This Changes For You
If one of your main concerns with clinical trial software is the lack of guidance on system compliance and documentation, what we’re doing with DQA sets a new standard. Use it as your guide for how things should work with every system you implement.
This isn’t just about Mayet, it’s about raising your expectations for what validation support should look like across the board, because in clinical development, the question isn’t whether documentation exists, it’s whether that documentation actually supports you when auditors show up and you need to defend your validation approach.
Ready to see what comprehensive validation support actually looks like? Contact the Mayet team, we’ll show you the difference, and you can use that understanding to evaluate every software vendor you work with.
Because you deserve validation and support that gives you confidence, not just paperwork that gives you anxiety.
About Mayet Solutions Ltd Mayet transforms clinical trial vendor management through software solutions built for sponsors and CROs who need to bring drugs to market faster while maintaining robust compliance standards.
About Digital Quality Associates Ltd Digital Quality Associates provides end-to-end compliance services for GxP-regulated industries, specialising in computer system validation, quality assurance, and regulatory compliance consulting for modern software environments.
