Reinvention Lab: Building Decision Quality in Regulated Industries
Reinvention Lab: Building Decision Quality in Regulated Industries
This session is the preview. The full hands-on workshop, the Reinvention Lab Mini-Lab, runs the morning of October 8 in Philadelphia, Day 2 of KENX MedTech Validation University. August 19 shows you the framework. October 8 is where you apply it to your own organization.
CSV was built for on-premise software, waterfall development, and paper-based quality systems. That framework delivered value in its time. The world it was designed for no longer exists.
- What organizational reinvention means in a regulated environment — not a rebrand, not a technology upgrade, not a compliance response
- The three conditions every quality decision must satisfy: Conscious, Defensible, Continuous
- Why "coverage roulette" is the hidden cost no one is measuring
- A first look at the DQI Framework you'll work with hands-on at the October 8 Mini-Lab
Free to attend. Can't join live? Register and we'll send the recording.
You're registered.
The join link is on its way to your inbox. Add it to your calendar for Wednesday, August 19 at 11:00 AM EDT — and if you can't make it live, the recording comes to the same address.
While you wait: the Mini-Lab on October 8 is where this becomes hands-on work on your own organization's decisions.
See the Mini-Lab on the agenda
ProcellaRX is a strategic consulting and digital validation firm specializing in computer software assurance (CSA), computerized system validation (CSV), AI governance, and regulatory compliance for life sciences, pharmaceutical, biotech, and medical device companies.
Your facilitator.
Dori Gonzalez-Acevedo
Dori created the Decision Quality Intelligence (DQI) Framework and founded the Reinvention Lab to rebuild how regulated organizations make quality decisions. She facilitates the Mini-Lab in Philadelphia on October 8.
Validation practice is anchored to an era that is over.
Today, organizations deploy cloud-native SaaS platforms updated weekly. AI and machine learning are moving from research curiosities into production-quality workflows. Regulators have clearly signaled that least-burdensome, risk-based approaches are not merely acceptable — they are preferred. And yet many validation practices remain anchored to an era that is over.
The Reinvention Lab was founded on the conviction that this moment demands more than incremental adjustment. Join Dori Gonzalez-Acevedo for a conversation about what the Lab is, why it exists, and why this industry moment demands it.
"Davos for Digital Validation." Reinvention is not disruption. It is not innovation theater. It is the deliberate, disciplined reconstruction of how an organization makes decisions — at the system level, not the surface level.
What we'll cover in sixty minutes.
- Why the industry is at a decision-quality inflection point, and what organizations that are not reinventing will look like five years from now
- What organizational reinvention means in a regulated environment: not a rebrand, not a technology upgrade, not a compliance response
- The three conditions every quality decision must satisfy — Conscious, Defensible, Continuous — and how most organizations satisfy none of them by design
- Why "coverage roulette" is the hidden cost no one is measuring, and what replaces it in a risk-based, process-first model
- How the Lab structures hands-on practitioner work across People, Process, Tools, and Culture
- Why the Lab format produces different outcomes than panels and conference sessions
- How to determine which Reinvention Lab offering is the right entry point for your organization
What the 2025 cohort produced.
On October 24, 2025, thirty-seven practitioners met at the NC Biotechnology Center in Research Triangle Park — five pharmaceutical companies, five vendor organizations, quality leaders, validation engineers, technology partners, and regulatory professionals. They named four systemic challenges, then wrote a shared thesis.
"We believe digital validation must be reinvented from the ground up to align assurance with real risk, accelerate value delivery, and make trust visible."
Who should attend.
- Quality directors and VP-level leaders responsible for the design of quality systems, not just their maintenance
- Validation and CSA practitioners managing digital quality programs, software governance, and lifecycle strategy
- Regulatory affairs professionals building documentation frameworks that must hold under inspection
- R&D and quality engineering leaders navigating AI integration, design control, and product change governance
- Device manufacturing professionals managing DHF/DMR systems and design control lifecycle decisions
- Operations and IT leaders who make or influence People, Process, and Tools decisions in regulated environments
And any leader who has built a compliant quality system and still asks why the same problems keep recurring.
August 19 is the conversation. October 8 is the work.
The Reinvention Lab Mini-Lab runs the morning of October 8 — Day 2 of KENX MedTech Validation University, co-located with GMP University. It is a condensed, hands-on session where participants apply the DQI Framework to their own organization's decision failures, with ProcellaRX facilitation. No product pitches. No passive audiences. Seats are limited.
