Conversations That Matter
No deviation’s Takeaways from 2025 ISPE Conference in Singapore
Panelists: Dave O’Connor, C&Q Digital Transformation Manager, No deviation, Hazem Eleskandarani, Senior Director, Global Quality Engineering, CSL Behring, Pierre Winnepenninckx, CQV CoP Lead, ISPE Singapore Affiliate & CEO, No deviation, Sebastian Scheler, MD & Chief Methodologist, Innerspace, Yiming Peng, Global Data Science Lead, Pharma Technical Operations, Genentech Inc
QRM, CQV & the Human Side of Digital: Insights from ISPE Singapore
“It’s not a licence to take risks.”
That line framed the ISPE Singapore panel on Quality Risk Management (QRM) and CQV in the digital era. Twenty years after risk-based approaches entered the room, we’re still correcting the same misconception: risk-based doesn’t mean do less—it means focus on what matters, prove it, and mitigate what parameters could impact patients and product.
From “risk-based” to risk-literate
Recent updates to guidance (e.g., ICH Q9) target subjectivity and bias in risk assessments. The panel’s message was blunt: too often, teams use “risk-based” to justify shortcuts. The discipline is the opposite—identify risks, assess their impact, and design proportionate controls.
Reality check: regulators are often less nervous than we are internally. One European inspector reviewed a single document and closed with, “Oh yeah, done a good job.” Competence, traceability, and clarity travel well.
What digital actually delivers
Digital isn’t just faster paperwork. The panel mapped tangible outcomes:
- Yield & quality gains – AI/ML helps operators tune complex processes (think biologics) to maximise product quality and throughput.
- Compliance by construction – Connected, traceable data enforces data integrity; in-system checks reduce human error and deviation patterns before they swell.
- Human capability boost – Drafting that took a week to get to 80% now gets there in a day—or an hour—with AI-assisted templates.
- Knowledge that compounds – Beyond static SOPs, organisations are building queryable knowledge management that preserve expert know-how as people rotate or retire.
Where it bites: applications that change the work
- Risk-proportional testing (CSA mindset) – Link URS directly to test artefacts; reserve robust testing for high-risk functions and apply exploratory/Ad-hoc testing where risk is low.
- Digital maintenance – Shift from fixed intervals to data-driven and predictive upkeep using sensors and analytics.
- End-to-end validation, requirements traceability matrix (RTM) – One digital thread from process understanding to test evidence, consistent and audit-ready.
Mind the maturity gap
Today’s tools still need work. Even simple tasks—like prioritising the most important risks—can feel clunky. The next wave emphasises transparent mechanics, stronger APIs, object-linked knowledge, and answers that are not only faster but verifiable.
The human element decides the outcome
- Start with “why” – Adoption follows value. Show the purpose and the win, not just the platform.
- Same team, new muscle – Digital validation still needs the validation team—plus early, cross-functional input to avoid late rework and narrow templates.
- Own the templates – Without stewardship, templates fossilise. With ownership, they learn and improve.
- Soft skills matter – Distinguish emotional resistance from legitimate concerns, coach through the change.
- A new workforce – Digital natives won’t go back to paper. Frontline roles need digital fluency and problem-engineering; data scientists still need code and domain sense.
Pick problems, not shiny tools
Don’t let AI novelty distract from impact. Define the problem, rank by business and patient value, then digitise where it moves the needle. And remember the hidden line item: the cost of not doing it.
What’s next
Cheap, ubiquitous sensors will reshape monitoring—continuous mapping may retire some periodic re-qualification routines. Vendors are competing hard, and that pressure is accelerating useful innovation.
The takeaway
Digital QRM and CQV are not about doing less—they’re about doing the right targeted work with evidence, visibility, and resilience. The organisations that win will be those that pair risk-literacy with digital governance and human capability—turning documents into decisions, and decisions into better outcomes for patients.
Want to go deeper?
Contact us at hello@nodeviation.com and let’s have a conversation that matters.
