21 CFR Part 11 - Compliance with SaaS/Cloud Software Applications 2018

Topics

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

Who should Attend

• IT
• Computer System Users
• QC
• QA
• Managers
• Laboratory Staff
• Auditors
• GMP, GCP, GLP Professionals
• Software Vendors