This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates.

Learning Objectives:-

• Which data and systems are subject to Part 11 and Annex 11
• Computer Software Assurance impact on risk-based
• Impact of Electronic Systems… Clinical Investigations Q&A Guidance for Industry Oct 2024
• Avoid 483 and Warning Letters
• Requirements for local, SaaS, and cloud hosting
• Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Areas Covered in the Webinar:-

• What 21 CFR Part 11 means today
  • Purpose of Part 11
• What does Part 11 mean?
  • SOPs
  • System features
  • Infrastructure qualification
  • Validation
• Hardware is qualified
  • IQ/OQ/PQ
• GAMP categories
  • No validation
  • Software Validation (SV)
  • Computer System Validation (CSV)
• Expansion for industry categories
  • Qualification of software utilities
  • Hybrid Validation
  • Statistical Analysis Program Validation
  • Medical Device Software Validation
• Evolution of COTS CSV
  • Test-based
  • Risk-based
• Validation
  • Software Validation for vendors
  • Computer System Validation for users
  • Change control re-validation
• SaaS/Cloud hosting
  • Responsibilities for software vendor and hosting provider
  • Evaluation criteria
  • Hosting requirements
• How to implement compliance
  • Software inventory
  • Validation models and templates

Who Will Benefit:-

• GMP, GCP, GLP, regulatory professionals
• QA/QC
• IT
• Auditors
• Managers and directors
• Software vendors, hosting providers