21 CFR Part 11, §11.10 and §11.50
21 CFR Part 11, §11.10 and §11.50 (ecfr.gov) (20 min)
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In: LABLOOP-W33 Notebook
WEEK 35 · LABDOCS, PART 3
Do one thing.
Then you are ahead.
This week the instruments start talking to each other. When batchlens raises an alarm (week 3), a QA person must write a deviation report: what happened, which SOP applies, what the corrective action is. labdocs drafts it: alarm + relevant SOP paragraph → draft → human approval → signed record in eLabFTW. The human stays in the loop, like a pilot who reviews the autopilot's plan before accepting it. Then the argumen…
If you only do one thing this week: the benchmark table
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THE NEXT BLOCK
How long have you got?
By Sunday you should be able to say: “I can show an alarm becoming a signed deviation, and a table of what a lab can run without sending data anywhere." --- # ACT VIII · Peer review and the crossroads (weeks 36-40) > Act VIII story. The expedition comes home. The maps go to the geographical society, where reviewers you have never met will check them. You give the lecture. A fund asks whether you can survey all its territories at once. And at the end, standing at the crossroads, you decide where to settle: your own office with long-term clients, a salaried seat at a map-making company, or both. The decision is written down, because a decision in your head is a mood”
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MOMENTUM
What you have actually done
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