Recorded live at CSV & CSA University 2025 · Top-rated session
Balance Scripted and Unscripted Testing Using Risk-Based Impact Assessments
Which tests need a full script, and which can be unscripted? How a risk-based impact assessment sets the level of testing for new systems, upgrades and SaaS releases. A practical starting point for teams new to CSA.
Margaret Hindley, MBA, PhD, CQA, CQE
Director, Computer Software Assurance, IT, Taiho Oncology, Inc.
“Best session of the event.”
“The best presentation of the second day, very practical.”
4.51 / 5 from 39 attendee ratings · 90% rated it 4 or 5
What you'll take away
- How to decide, test by test, between scripted and unscripted testing based on the risk of the change
- How the decision changes for a new system, an upgrade, and a SaaS release you don’t control
- Using a risk-based impact assessment to set the level of testing for each change
- Documenting the testing decision so it holds up
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Balance Scripted and Unscripted Testing Using Risk-Based Impact Assessments
Sessions like this one are what CSV & CSA University 2026 is built on. Keep scrolling for 35+ more, live in San Diego, CA on December 9 & 10, 2026.
If you liked this session, there are more like it at
CSV & CSA University 2026
December 9 & 10, 2026 · San Diego, CA · In person or virtual
Rates and deadline to confirm
December 9 and 10, 2026 · San Diego or virtual
This year’s agenda picks up where Hindley left off.
Two days of practitioners presenting the work they run: making the move from CSV to CSA, right-sizing CSA evidence, supplier assurance for SaaS and AI, continuous validation for AI systems, and validating the software that runs your plant. Plus a cross-industry panel on CSV, CSA and AI adoption.CSA transition
CSV vs. CSA: Understanding FDA's Shift — What Changes, What Stays & How to Transition Your Validation Program
What the move from CSV to CSA changes in practice, what stays the same, and how to transition an existing program.
Paul A. LabasHead Clinical QA IT and Validation CoE, Sarah Cannon Research Institute
CSA evidence
Right-Sizing Your CSA Evidence Package: A Decision Framework for What to Keep, Cut, and Defend
A decision framework for how much evidence each change needs, and how to defend what you left out.
Joanne GoldbergSr. Principal Business Analyst, Medtronic
Supplier assurance
Quality Agreements for SaaS & AI Suppliers: Assuring the Vendors You Can't Audit
How to assure SaaS and AI vendors when a traditional audit is not an option.
Geetanjali (Geetu) AbbiDirector, Head of Digital Quality Assurance, Alkermes
AI validation
Continuous Validation for AI Systems: Managing Drift, Retraining & Change Control
Keeping an AI system in a validated state as models drift and get retrained.
Funmi Ladigbolu, MBA, MPA, MAQA & Compliance, Gilead
“The best presentation of the second day, very practical.”
Attendee, CSV & CSA University 2025, on Margaret Hindley’s session
Speaking from inside the regulated world
Who is on the faculty.
Case studies from the quality, validation and IT leaders who own CSV and CSA in their organizations.
Medtronic
Sarah Cannon Research Institute
Gilead
Alkermes
Alcon Laboratories
Johnson & Johnson
Guardant Health
RCM Data & Solutions
ProcellaRx
Genari AI
See the rest of the sessions in December.
December 9 and 10, in San Diego or virtual. Two days of CSV and CSA sessions from practitioners.
