WTF were you lawyers doing for 250 year?

You can, and should castigate The Defiler, and his minions.

You should also #Lookinthemirror, learn what #CAPA means, and shut down all the poisoned Ivy Halls.

A complaint isn't automatically a reportable incident, and an incident isn't automatically a CAPA. Confuse those three clocks and your own procedure becomes the finding. #MDR #CAPA #Vigilance

QSIT findings get written up as "procedure not followed." The recurring root cause across warning letters: one QA person covering four sites, CAPAs closed because the deadline hit, no one reading management review. Resources, not SOPs. #FDA #QSIT #QMS #CAPA

158,673 reports on failure-to-osseointegrate and most of us are filing them one-by-one. We shouldn't be.
api.fda.gov/device/event.json?search=date_recei…

#CAPA #RiskManagement #RegulatoryAffairs

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O novo Brasil que a política (ainda) ignora.
- bsoplvr
https://outraspalavras.net/crise-brasileira/novo-brasil-que-a-politica-ainda-ignora/
#CriseBrasileira #Acessointernet #Bigtechs #Capa #Dados #Eleies #Esquerdabrasileira #FlvioBolsonaro #Industrializao #Infraestruturadigital #Lula […]

管理レビュー前日のQAデータ集め、あの慌ただしさはQMS設計の鏡 (mirror of QMS design). Good reporting means answers are already there. QmsWrapper is one option, weigh against MasterControl, Greenlight Guru, Qualio. #MedicalDeviceQMS #ISO13485 #AuditReady #CAPA #qmsWrapper
youtube.com/watch?v=76pQv-X7cpA

Assim se encara a ultradireita.
- bsoplvr
https://outraspalavras.net/crise-brasileira/assim-se-enfrenta-ultradireita/
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OncoMate's PMA is impressive; but approval day is day one of the harder job. Evrey change,, supplier shift from here defends that approval for the device's lifetime.

#ChangeControl #CAPA #RegulatoryAffairs

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Milícias, Faria Lima e governos: a zona cinza.
- bsoplvr
https://outraspalavras.net/crise-brasileira/milicias-faria-lima-governos-a-zona-cinza/
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Milícias, Faria Lima e governos: a zona cinza.
- bsoplvr
https://outraspalavras.net/estadoemdisputa/milicias-faria-lima-e-governos-a-zona-cinza/
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Sequential task forms in modern eQMS lock each step behind the prior one. Step 3 doesn't open until steps 1 and 2 are signed, so the 'did they actually do it' question stops reaching the auditor's inbox. #eQMS #CAPA #QMSR

Class III PMA approval and a Class II recall trending in the same week. Companies obsess over the DHF. The QMS that handles the post-market grind is what determines whether you stay on market.

#RegulatoryAffairs #DesignControl #CAPA

68k events coded "no identified device or use problem." "we don't know" is not a status. Feed unfiltered and your benefit-risk file is a story you're telling yourself.
api.fda.gov/device/event.json?search=date_recei…

#FDACompliance #MedTech #CAPA

Investigation clock starts the moment a record opens. AI autofill pulls complaint ID, device serial, CAPA parent, risk file ref in seconds: #QMS #CAPA #eQMS
youtube.com/watch?v=UoErqQW-hOo

Derrotar Flávio e libertar Lula do arcabouço.
- bsoplvr
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