21 CFR Part 11 is where 'approve by email' shops quietly fail — a typed name is not a signature
This story is from 2026-10-11. It is preserved in the archive; the latest stories are on the live feed.
The CAPA that taught me what an email isn't Two years ago I inherited a CAPA queue that included a finding from our prior notified body audit. The wording was polite but unambiguous: "The approval records for the post-market surveillance report could not be verified against a Part 11-compliant syst…
Read the full story at DEV Community — AI ↗
Timeline · 1 report
- 2026-10-11 01:24 · DEV Community — AI
21 CFR Part 11 is where 'approve by email' shops quietly fail — a typed name is not a signature
More stories
- Introducing GPT-6 in ChatGPT with Intelligent UI — OpenAI YouTube
- An Anthropic AI model sent a false homicide tip to Philadelphia police — TechCrunch AI
- Anthropic bans users from ‘needless abusive or cruel behavior’ towards Claude — The Guardian AI
- Philadelphia police receive false homicide tip from Anthropic AI model — The Hill Technology
- Qwen Image 2.1 Turbo Released -- Hugging Face — r/StableDiffusion
- Impactful scheduling for GPU clusters — Allen Institute for AI (Ai2)
- Sophos cuts threat investigation time by 96% with OpenAI Daybreak — OpenAI News
- Welcome to Gemini at Work 2026: Introducing the Gemini agent — Google Cloud AI Blog
Get the daily brief of stories like this at 6:30 every morning →