Jason Cohen

asmartbear.com

28 May 2026 14:35

How do I 𝘬𝘯𝘰𝘸 that it’s 100x easier to make software than to understand customers, get their attention, and sell to them? Because I know 100 engineers who can build software for every 1 founder who got 100 people to buy something.

Daniela K.

samqadani.bsky.social

27 May 2026 16:55

If devs live in jira/github, stop pasting tickets into "docs" two weeks before audit. Capture immutable snapshots in your, connected workflow, reviewability &. Audits stop being panic theater. #Compliance #eQMS #Traceability

Thomas Brenner

regafraid.bsky.social

27 May 2026 16:54

To be technically accurate, AI/ML SaMD change control must treat model updates as ongoing validation events, linking predefined release criteria to documented acceptance, real-world monitoring, and retraining governance; otherwise a predetermined plan is lip service.

heartgest

heartgest.bsky.social

27 May 2026 16:52

Okay hear me out, SaMD audits reveal the gap: DHF traceability gaps when AI updates outrun change control, so CAPAs look closed but evidence trails crumble in notified-body audits. EQMS migrations (MasterControl to qmsWrapper) expose it in practice.

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