Design Verification & Validation Protocol Authoring demo
Verification protocols drafted from the input, the standard and the risk file, with no unexplained choice reaching review. 1:28
What the demo shows
Protocol authoring for device test engineers: worst cases, sample sizes and criteria sourced.
Agents start each protocol from the closest approved one, then check every choice: the worst-case condition from the input's ranges and the tolerance stack, the sample size from the risk file's severity and the sampling procedure, and each pass/fail line against the input it proves. The test engineer accepts or edits each choice with a reason, the systems engineer settles any line that traces to no input, the biostatistician decides any smaller plan, and a design quality engineer opens every reason before approving with an e-signature.
Transcript
- Design Verification and Validation Protocol Authoring drafts device test protocols.
- ISO 13485 wants sample sizes justified; this copy justifies nothing.
- Agents check each choice against input, standard and risk file.
- Worst case: one milliliter an hour, narrowest set, ten degrees; the hazard is serious, so 59 trials become 299.
- Pallavi, the test engineer, accepts each reason.
- Corentine, the systems engineer, types her reason and signs: that line becomes recorded data.
- Pallavi signs it into review with her own user ID and password.
- Yevgenia must read each reason, including Corentine's ruling in her words.
- She reads the criteria, then signs as herself: approved for execution.
- Fausto books 299 trials: four lab days.
- Built on Botminds: agents, data, screens and governance on one platform.
The narration as written for the film. Captions are on the player.