Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026
Learn which systems fall under Part 11 and Annex 11, how to control SaaS and cloud systems, review audit trails, use e-signatures and meet EU GDPR privacy duties.
Speaker
Carolyn Troiano
Computer system validation consultant · 35+ years in computer system validation
Overview
Data integrity and privacy risks are not limited to one team. They appear wherever regulated data is created, reviewed, moved or relied on, from quality and IT to labs, clinical, manufacturing and suppliers. 21 CFR Part 11 expects electronic records and e-signatures to stay trustworthy and controlled throughout.
This 90-minute webinar connects Part 11, EU GMP Annex 11 and EU GDPR with how SaaS, cloud hosting, remote access, integrations and vendor logins really work. It looks at the weak points FDA warning letters keep citing: excess admin rights, audit trails not enabled or not reviewed, gaps in lab data backup, and invalidated failed results without a sound root cause.
The aim is clear governance, clear controls and evidence you can defend in an inspection, without overbuilding your validation program.
Why attend: Most data integrity and privacy failures come from everyday gaps in permissions, admin access, audit-trail review, reanalysis, exports and vendor access that build up until an inspection forces a costly cleanup. This session helps you spot them early and describe them in the terms regulators use. It is especially useful for hybrid environments that mix local systems, SaaS, spreadsheets and vendor portals, helping QA, IT, validation, lab, regulatory, privacy and audit teams agree on practical controls and SOPs.
What’s covered
- Which data and systems fall under Part 11 and Annex 11
- How to write a data privacy statement
- What the regulations mean, not just what they say
- Avoiding 483 observations and Warning Letters
- Requirements for local, SaaS and cloud hosting
- Current industry-standard software features for security, data transfer, audit trails and electronic signatures
- Using electronic signatures, ensuring data integrity and protecting intellectual property
- SOPs required for IT infrastructure
- Product features to look for when buying COTS software
- Reducing validation effort with simple fill-in-the-blank validation documents
Who should attend
What you get
About the speaker
Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
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