Recorded live at GMP University
Surviving a Data Integrity Audit
Red flags, best practices, and lessons learned. How a data integrity program was built from an unapproved draft policy and one open CAPA — then held up under an FDA pre-approval inspection and an EMA audit without a single data integrity observation.
Ivan Soto
Director IT Digital Quality & Governance, Dyne Therapeutics
What you'll take away
- What an FDA investigator assigned to nothing but data integrity actually does in the QC lab
- The four red flags that show up in the first hour of a data integrity audit
- A remediation plan that is 60% procedure controls and 40% technical — and why that ratio holds
- How to size a data risk assessment: 15 questions and half an hour per system, not an FMEA
- Where most data integrity issues hide: the paper-to-electronic handoff
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Surviving a Data Integrity Audit
Sessions like this one are what GMP University 2026 is built on. Keep scrolling for 35+ more, live in Philadelphia on October 7 & 8.
If you liked this session, there are 35+ more like it at
GMP University 2026
Co-located with MedTech Innovation & Validation University
Advance rate ends August 21 · from $1,595 · register 3, the 4th is free
October 7 and 8, 2026 · Philadelphia, PA
Where The Rest Of The Sessions Are.
Two days, 35+ case study sessions, and a faculty of practitioners who have sat in the front room: inspection readiness, data integrity, quality systems and remediation, CSA, Annex 1, and the questions inspectors are asking in 2026.
Featured session · Day two
Surviving a Data Integrity Audit: The Red Flags Inspectors Find in the First Hour
David DeLuca, Director, Strategic Consulting, Compliance Group
The 2026 edition of this session, live: the data integrity red flags inspectors find before lunch, and what a defensible program looks like when they do.
Also on the agenda
How to Survive an Audit of Your Validated Computerized Systems
Raul Soto, MedTech Senior Manager, Johnson & Johnson
What inspectors look for in real audits of validated systems, from the front line — and how to stay ready between them.
“60% of our remediation was procedure controls. We didn't get a single observation.”
Ivan Soto · at 23:48 in this recording
Chapter by chapter
What's In The Recording.
Ten chapters across 37 minutes. Complete the form above and the recording opens in place.
03:01Red flag one: no governance framework, and no risk-based approach
06:01Audit prep that fails — wrong SMEs in the
front room, wrong documents out of the back
08:22Remediating pH meters while ignoring the
HPLCs
09:25QC teams still running analytical development
data practices
12:05The 2023 FDA PAI: what the data integrity
auditor actually looked at
16:19The remediation plan: system inventory, gap
assessment tool, data mapping
21:59The ~100 data risk assessments he ran, then
stopped doing
23:4860% procedure controls, 40% technical — and no
observations
29:41Q&A: paper-to-electronic handoffs, where most
DI issues hide
33:39Keep it to 15 questions and half an hour per
system, not an FMEA
Speaking from inside the regulated world
Who is on the faculty.
Case studies from the quality, validation, and manufacturing leaders accountable when an inspector walks in.
Johnson & Johnson
Medtronic
Organon
Alcon
Takeda
Cencora
iRhythm Technologies
PQE GroupSTERIS Corporation
Yale School of Medicine
QualityHub
Compliance Group
The Silverman GroupProcellaRx
VTI Life Sciences
Kneat
Genari AI
Dyne Therapeutics
See 35 More Sessions Like This One.
Philadelphia, October 7 and 8. Advance rate ends August 21.
Advance rate $1,595 through August 21, first 15 attendees · Register 3, the 4th is free · Attend in person or virtually
Co-located with MedTech Innovation & Validation University
