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David Nettleton
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR - AI
Pharmaceutical
Live Webinar
Oct 08, 2026 , 01 : 00 PM EST

|  8 Days Left
 90 Minutes

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Description

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.

Why you should Attend:

  • How Part 11 works with AI
  • Which data and systems are subject to Part 11 and Annex 11
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents
  • What the regulations mean, not just what they say
  • Avoid 483 and Warning Letters
  • Requirements for local, SaaS, and cloud hosting
  • Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
  • How to use electronic signatures, ensure data integrity, and protect intellectual property
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software

Areas Covered in the Session:

  • What 21 CFR Part 11 means today
    • Purpose of Part 11
    • How Part 11 works with AI
  • What does Part 11 mean?
    • SOPs
    • System features
    • Infrastructure qualification
    • Validation
  • Security standards
    • Roles
    • Usernames and passwords
    • Restrictions and logs
  • Data transfer standards
    • Deleting data
    • Encryption
  • Audit trail standards
    • Types of data
    • High risk systems
  • Electronic approval standards
    • Electronic signatures
    • Single sign-on
    • Replacing paper with electronic forms
  • Infrastructure qualification
    • How to efficiently document qualifications
  • Validation
    • Software validation for vendors
    • Computer system validation for users
    • Fill-in-the-blank templates
    • Change control re-validation
  • SaaS/Cloud hosting
    • Responsibilities for software vendor and hosting provider
    • Evaluation criteria
    • Hosting requirements
  • SOPs
    • IT, QA, validation
    • Software development
    • Annex 11
    • Comparison with Part 11

Who Will Benefit:

  • GMP, GCP, GLP, Regulatory Professionals
  • QA/QC
  • IT
  • Auditors
  • Managers and Directors
  • Software vendors, Hosting Providers
Training Options
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Speaker

David Nettleton

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with developing, purchasing, installing, operating, and maintaining computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates...