GxP Data Integrity in Cloud-Based Quality Systems
Practical guidance for maintaining ALCOA+ compliance when your QMS, LIMS, and MES have moved to SaaS platforms — with case examples from recent FDA warning letters.
Moving quality-critical systems to the cloud collapses the traditional CSV playbook. This session unpacks how leading pharma companies are rebuilding data integrity controls under 21 CFR Part 11 and EU Annex 11 for SaaS-hosted QMS, LIMS, and MES environments, using a risk-based Computer Software Assurance (CSA) approach.
You will hear real audit narratives from the last 18 months, including three FDA warning letters that hinged on cloud audit trail gaps, and leave with a checklist you can apply on Monday morning.
Session agenda
The current FDA and EMA position on cloud-hosted GxP systems, and why the goalposts have moved in 2025.
Three recent inspection observations dissected — root cause, remediation, and the control gap that opened the door.
Bring your toughest data integrity questions — the panel will tackle them live.
What you'll learn
Your speakers
Good to know
Yes. Registered attendees receive the on-demand recording and slide deck within 48 hours of the live session.
Absolutely. The frameworks discussed scale from small CDMOs to global manufacturers — we call out where the effort differs.
A signed attendance certificate is provided; whether it maps to CPD credit depends on your professional body.
Get a calendar invite the moment a webcast is announced.
One short email per session — title, speakers, and a one-click add to your calendar. Nothing else.