Computer Software Assurance: Use industry standards to be efficient and compliant

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:

1. What 21 CFR Part 11 means today
   • Purpose of Part 11
2. What does Part 11 mean?
   • SOPs
   • System features
   • Infrastructure qualification
   • Validation
3. Hardware is qualified
   • IQ/OQ/PQ
4. GAMP categories
   • No validation
   • Software Validation (SV)
   • Computer System Validation (CSV)
5. Expansion for industry categories
   • Qualification of software utilities
   • Hybrid Validation
   • Statistical Analysis Program Validation
   • Medical Device Software Validation
6. Evolution of COTS CSV
   • Test-based
   • Risk-based
7. Validation
   • Software Validation for vendors
   • Computer System Validation for users
   • Change control re-validation
8. SaaS/Cloud hosting
   • Responsibilities for software vendor and hosting provider
   • Evaluation criteria
   • Hosting requirements
9. 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

Industries which will get benefit from this training include Pharmaceutical, Medical Device, Biologics, Food, Cosmetics, FDA regulated companies, Software vendors, SaaS providers, Data centers