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

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