With the recent publication of FDA’s CSA Draft Guidance, there is much discussion surrounding Computer Software Assurance implementation, critical thinking, and risk assessments. In addition, the new draft guidance has affected another FDA regulatory hot button – 21 CFR Part 11 (Electronic Records and Signatures).

This training uncovers the impact of FDA’s new Computer Software Assurance guidance on 21 CFR Part 11 and the controversy surrounding these areas. This will be in the next big task for FDA and global regulatory agencies are already tackling the challenges (PIC/s and EU’s Annex 11).

Delivering Computer Systems Validation & Software Assurance Best in Class Processes from A-Z

• FDA Releases Computer Software Assurance (CSA) Guidance – Get Up-to-the-Minute Details
• The Intersection of CSA and AI/ML Used in GxP Systems
• Conduct a 21 CFR Part 11 Electronic Records Gap Analysis
• Build a Modern, Risk-based CSV Program Using CSA, Part 11, Data Integrity, and Innovative Technology
• Modernize Conducting Software Risk Assessments
• Qualifying SaaS, IaaS, and Other Cloud Platforms
• Create and Use a Checklist for Conducting a GAMP® 5 Assessment
• Unpack FDA’s CSA Draft Guidance
• Modernize your risks assessments, critical thinking, and CSV programs by transitioning to CSA methodology
• Discover the Impact CSA has on 21 CFR Part 11 and What this Means for You
• Conduct a 21 CFR Part 11 Gap Assessment