Conversations That Matter
No deviation’s Takeaways from 2025 ISPE Conference in Singapore
Speaker: Dave O’Connor, C&Q Digital Transformation Manager at No deviation, One of the authors of the new ISPE Good Practice Guide author on digital validation.
“Four years ago, I was still working with paper.”
That’s how Dave O’Connor, an author of the ISPE Digital Validation Good Practice Guide, opened his session at ISPE Singapore. It was a simple statement but it set the tone for the entire talk: the industry has changed, and there’s no turning back.
From Need to Community
The guide itself was born out of recurring questions raised by major manufacturers, Lilly, Pfizer, and others around true copies, Audit processes, and engineering feedback. Instead of each company struggling alone, the solution was collective: “we need a Community of Practice.” That call for collaboration became the foundation of today’s digital validation movement.
What the Guide Covers
The structure of the guide reflects the journey most organisations face:
- Introduction & Good Concepts – defining digital validation.
- Business Case – building the argument for change and ROI.
- Implementation & Risks – moving from paper to digital.
- Governance – sustaining momentum after the excitement fades.
- Regulatory Considerations – ensuring alignment with inspectors.
And for those looking further ahead, a Concept Paper explores what digital validation could look like in 2030 and beyond.
The Current State: Acceleration, Not Stability
Despite being discussed for more than a decade, digital validation has only truly accelerated in the last five years, driven by the pandemic and shifting mindsets towards Pharm 4.0. Today, most of the top 10 pharma companies are onboard. Yet Dave was clear: “we have absolutely not reached a steady state.”
The market is dynamic, with new tools, suppliers, and integrations emerging constantly. What began with EDMS repositories has evolved into full digital execution and the next horizon is seamless integration across the pharma digital ecosystem.
Benefits That Stick
Dave highlighted the concrete wins:
- Data integrity by design – signatures, timestamps, and audit trails built in.
- Faster global collaboration – reviews done in 24 hours across time zones.
- Audit readiness – digital folders let auditors see only what has been requested
- Sustainability – eliminating paper across global operations.
- Integration – APIs linking validation with maintenance, change control, and project planning.
- Standardisation – governance and templates cutting costs and training time and improving Knowledge Management.
But the Hardest Part Isn’t Technology
“Don’t underestimate the cultural change,” Dave warned. Teams that have lived in a paper world for decades don’t shift overnight. Digital tools won’t fix a struggling validation group without proper resourcing, training, and governance. And organisations need to plan not only for adoption but also for the eventual retirement and migration of digital platforms as new tools come to the market.
Looking Ahead
The Concept Paper pushes suppliers for the next leap: smarter APIs, automated progress reporting, integration with P6 project tools, and direct data transfer between departments. In other words, not just digitising documents but digitising the way pharma works.
The Takeaway
For Dave, the Digital Validation Guide is more than a technical manual. It’s a collective effort, shaped by industry voices across the globe, designed to help teams avoid the mistakes of early adopters.
“It’s what I wish I had four years ago before I started my own digital journey,” he admitted.
At No deviation, we see conversations like this as milestones for our industry. They remind us that digital validation is not just a tool. It’s a mindset shift, a governance challenge, and a pathway to a smarter, more connected future.
Want to go deeper?
Contact us at hello@nodeviation.com and let’s have a conversation that matters.
