Upcoming webcastRegulatory Compliance
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.
Host & moderator
Dr. Anika Desai
Head of Quality Assurance · Novartis
Date
Wed 22 Jul 2026
Time
10:00 UTC
Duration
60 min
Price
Free
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FreeRegister once — attend live or watch the replay.
About this session
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
10:00 – 10:10
Opening & regulatory landscape
The current FDA and EMA position on cloud-hosted GxP systems, and why the goalposts have moved in 2025.
10:10 – 10:35
Case studies from the field
Three recent inspection observations dissected — root cause, remediation, and the control gap that opened the door.
10:35 – 11:00
Live Q&A with the panel
Bring your toughest data integrity questions — the panel will tackle them live.
What you'll take away
1
How ALCOA+ principles translate to SaaS-hosted QMS and LIMS environments
2
Configuring audit trails and access controls that satisfy 21 CFR Part 11
3
A CSA-aligned risk assessment template for cloud vendor qualification
4
Three recent FDA warning letters — what went wrong and how to avoid it
Your speakers
Host
Dr. Anika Desai
Head of Quality Assurance · Novartis
Panelist
Ravi Menon
Director, Regulatory Affairs · Sun Pharma
Good to know
Will the recording be available afterwards?+
Yes. Registered attendees receive the on-demand recording and slide deck within 48 hours of the live session.
Is this session suitable for smaller CDMOs?+
Absolutely. The frameworks discussed scale from small CDMOs to global manufacturers — we call out where the effort differs.
Can I claim CPD credit for attending?+
A signed attendance certificate is provided; whether it maps to CPD credit depends on your professional body.
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