HeyJaredJon O'Connell
- Indexed articles, last 90 days
- 3
- Latest publication
- Sep 28, 2026
- Outlet visibility, for Meddeviceonline
- Top 10M sites
- Earliest in this view
- Sep 3, 2026
Latest articles
ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions (opens the original)
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A conversation between Katie Duncan at GSK and Life Science Connect's Jon O'Connell ICH M4Q(R1) — the quality module of the common technical document — was written for a pre-digital era of regulatory CMC review. Today's submissions are vastly more complicated, and they're expected to support much faster regulatory assessments. To catch up with regulatory expectations and greater data demands, the International Council for Harmonisation (ICH) set out to overhaul M4Q(R1) and develop the M16 Struct
Building Trust In AI For Computerized System Validation (opens the original)
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A conversation between Frank Henrichmann at Q-Finity and Life Science Connect's Jon O'Connell Misguided confidence is one of artificial intelligence's greatest traps. Anybody who has watched ChatGPT return an incorrect response with utter confidence can imagine the danger it poses when allowed to play within validated systems, let alone assist in the validation to begin with. With a measured level of trust and the correct guiderails, however, AI can slice out some of the repetitive work of compu
When To Trust And When To Verify AI-Enabled Validation Systems (opens the original)
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A conversation between Louie Rayal of GSK and Life Science Connect's Jon O'Connell FDA's 2022 guidance on computer software assurance (CSA) and other recent regulatory position papers have paved the way for artificial intelligence to support the validation life cycle. When the focus is on assessing risks and potential failure modes, AI can substantially speed up the steps through test development and script writing, among other mundane validation-associated tasks, giving the humans more time to
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