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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