Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
2026 Updates
Register Now- Interpreting 21 CFR Part 11 requirements for AI and modern digital systems
- Mapping SOPs, system features, infrastructure, and validation responsibilities
- Defining security controls including access, roles, and system logs
- Applying audit trail and electronic signature expectations
- Evaluating SaaS and cloud vendor responsibilities and hosting requirements
- Aligning validation approaches for vendors and system users
- Addressing Annex 11 and EU GDPR data privacy requirements
- Establishing data transfer, encryption, and retention controls
Data integrity decisions across cloud and local systems require clear alignment between system features, SOPs, validation scope, and regulatory expectations before implementation begins.
This session structures how regulatory requirements translate into system controls, documentation practices, and validation approaches across SaaS, cloud, and on-premise environments.
The session progresses through how regulatory expectations map to system design, SOPs, infrastructure qualification, and validation. It then addresses security, audit trails, and electronic signatures, before covering SaaS responsibilities, vendor evaluation, and data privacy considerations to ensure alignment across global regulatory frameworks.
David Nettleton brings more than 45 years of computer system validation experience across FDA-regulated industries. Her work in CSV, data integrity, large-scale system implementation, and 21 CFR Part 11 development provides direct context for evaluating spreadsheet risk, selecting appropriate validation activities, and maintaining Excel applications in a controlled state throughout their GxP lifecycle.