1、Using AI Demonstrate Value of QA,Martin Lush MLC Quality Business Leadership Summit 2025 16 May 2025 NIBRT,Dublin,1,Before we get started My Stake in the Ground,AI Applications:Here to stay Containment IMPOSSIBLEFaster,cheaper,more scalable ubiquitous powerful.Speed velocity:Overwhelming but beware
2、AI Snakeoil Every job has an expiry date clock is ticking.Longer you leave it bigger your personal risk.Traditional regulatory and governance WONT workAccelerants:Political Social Economic Pressures=ACT without thinking of unintentional consequences.We dont fully understand AI The technology will fa
3、il mistakes will happen we must remain capable.Education Systems exposing future generations,and your business,1a,Briefly:My A-ha Moment 2022,Knowledge(study guide)Martins decision-making algorithmCase studies&scenariosProduct release stress testing,2,Hello,Im Martin the idiot in the room(aka The Vo
4、ice of Common Sense),Before we start What is nonnegotiable?What questions must we answer?Focus on outputs and unintended consequencesAI+PEOPLE(unique qualities)=Win:Win,“Martin In my experience one idiot in the room is worth at least a dozen subject matter experts”,3,Your Due North:Common Sense Ques
5、tions,OK,why now?(Business imperative,FOMO,Silver Bullet?)What is our Design Intent?Algorithm Components and accuracy?What is our Data Source?What is our Training Protocol?How do we Validate Outputs-and maintain validated state?Unintended Consequences(fear and resistance)What are the Guardrails(syst
6、em safeguards?).current?!,4,Adapt Integrate-Or Be Automated.,Last Six Months:,Pharmacovigilance Regulatory submissionsAnnual Product Quality ReviewsDeviation investigations/report writing SOP creation,simplification and administration Product release life cycle Regulatory updates(consultants)Remedia