Case Study: Quality & Compliance Considerations for AI & Automation in TMF Management

Wed, May 13 | 01:15 PM - 01:40 PM

Session details:

  • Define how AI & automation-enabled TMF processes must align with GCP, ALCOA+, & inspection expectations
  • Establish validation & governance requirements for AI tools 
  • Specify clear acceptance criteria for automated outputs to ensure consistency & regulatory defensibility
  • Address compliance risks introduced by automated document handling 

Tags:
Clinical Quality , TMF
Track:
Clinical