Get clarity on exactly what 21 CFR Part 11, Annex 11, and EU GDPR require — covering local and cloud environments, AI-enabled software, electronic signatures, and validation documentation.
Includes live access & recording
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local and SaaS/Cloud hosted applications. It explains how to validate software employing Artificial Intelligence (AI).
What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
Participants will leave with a clear understanding of current industry standards for security, data transfer, audit trails, and electronic signatures — and with practical fill-in-the-blank validation tools to reduce the resources required for compliance documentation.
Many organizations struggle to distinguish between what 21 CFR Part 11 and Annex 11 literally say versus what they actually require in practice. The result is over-validation in some areas, dangerous gaps in others, and expensive rework when 483s or Warning Letters arrive.
SaaS and cloud adoption adds another layer of complexity — shared responsibilities between software vendors, hosting providers, and regulated users are frequently misunderstood, leaving organizations exposed.
This session provides the practical clarity needed to avoid 483s and Warning Letters, correctly scope validation efforts, and select and configure COTS software with confidence across local, SaaS, and cloud environments.
By the end of this session, participants will have the practical knowledge to scope, execute, and document compliant validation programs for local and cloud-hosted regulated systems.
Understand how 21 CFR Part 11 works with AI-enabled software in regulated environments.
Identify which data and systems are subject to Part 11 and Annex 11 requirements.
Reduce validation resources by using easy-to-understand fill-in-the-blank validation documents.
Understand what the regulations mean, not just what they say, across all four compliance areas.
Avoid 483 observations and Warning Letters by implementing the correct compliance framework.
Apply requirements for local, SaaS, and cloud hosting environments and understand vendor/user responsibilities.
Understand current industry standard software features for security, data transfer, audit trails, and electronic signatures.
Use electronic signatures correctly, ensure data integrity, and protect intellectual property in regulated systems.
Develop and maintain the SOPs required for IT infrastructure in a compliant, audit-ready state.
Identify key product features to look for when evaluating and purchasing COTS software.
Four focused areas that will sharpen your organization's approach to data integrity and Part 11 compliance.
Cut through ambiguity — learn what 21 CFR Part 11, Annex 11, and EU GDPR actually require across SOPs, software features, infrastructure, and validation.
Understand the shared responsibilities between software vendors and hosting providers and the evaluation criteria for compliant cloud-hosted regulated systems.
Master current industry standards for roles, passwords, encryption, audit trails, electronic signatures, and data transfer in regulated applications.
Use fill-in-the-blank templates and a risk-based approach to dramatically reduce validation effort while maintaining full compliance documentation.
A comprehensive 12-module deep-dive covering every critical dimension of 21 CFR Part 11, Annex 11, and EU GDPR compliance.
Professionals across regulated industries who need clarity on electronic records and signatures compliance for local and cloud-hosted systems.
GMP, GCP, GLP & Regulatory Professionals
QA/QC Departments
IT Departments
Auditors
Managers and Directors
Software Vendors & Hosting Providers
21 CFR Part 11 has governed electronic records and electronic signatures in FDA-regulated industries for decades, yet it remains one of the most misunderstood regulations in the life sciences. The rise of SaaS and cloud-hosted applications, combined with the rapid adoption of AI-enabled software, has introduced new layers of complexity around system validation, vendor qualification, and shared infrastructure responsibility.
Annex 11 provides the European equivalent framework, and organizations operating across both regulatory environments must reconcile the two. Meanwhile, EU GDPR requirements add data privacy obligations that intersect with — but differ from — the data integrity mandates of Part 11. Understanding where these frameworks align and diverge is essential for organizations managing multinational compliance programs.
This session delivers the practical clarity that compliance, IT, and validation professionals need to correctly scope validation efforts, implement the right software features, structure defensible SOPs, and avoid the 483 observations and Warning Letters that result from misunderstanding what these regulations actually require versus what they appear to say.
David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is Risk Based Software Validation – Ten Easy Steps, which addresses the development, purchase, installation, operation, and maintenance of computerized systems used in regulated applications.
He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. David has completed more than 185 mission-critical software validation projects across a wide range of regulated industries.
Don't miss this essential training on 21 CFR Part 11, SaaS/Cloud compliance, and EU GDPR. Get the clarity you need to avoid 483s and validate with confidence.