No cron sends this. A person does.

Run npm run digest against this product today and here is exactly what happens: it reads the approved items from the last seven days, renders them into an email, writes digest.html and digest.txt to disk, and prints the subject line to the terminal. Then it stops. There is no function anywhere in the codebase that sends that file to anyone. The script’s own header comment says why in one line: a human pastes this into a mail client and presses send, because that human is the last check before roughly fifty regulatory professionals act on it, and the moment an automated sender exists, that check is one forgotten cron job away from disappearing.

That is a real cost, stated plainly rather than hidden. A weekly digest that requires a person to open a file and paste it somewhere does not scale the way a cron-triggered send does, and the product says so: automate the send once the curation is proven, not before. What that buys, in the meantime, is a specific and narrow thing — not better curation, but a standing, un-automatable point at which a person looks at what is about to leave the building.

The quiet week is the case that matters most

The interesting failure mode isn’t a normal week with fifteen items in it. It is the week with zero. If no item cleared human review in the window, the digest still renders — as “nothing material changed,” per the product’s own design principle that silence has to be a stated finding, never a blank screen. But the script does not let that quiet output pass for free. It prints a warning in the terminal before handing control back: this renders as a finding, not a blank — confirm the review queue is actually empty at /review before treating it as one, because a quiet digest caused by nobody working the queue is wearing the same clothes as a quiet digest caused by an honestly quiet week, and only a person looking at the actual queue can tell them apart. The per-subscriber path is built the same way: quiet personal digests are generated and shown to the operator alongside the busy ones, specifically so nothing — including a subscriber’s all-clear — goes out unseen.

A decision to send nothing is still a decision. The product is built so that decision has to be made by someone, every time, rather than defaulted into by an empty inbox.

The same shape FDA asks of a complaint file

21 CFR 820.198(b) governs a different silence: a manufacturer decides a complaint does not need investigating. FDA does not forbid that outcome. It forbids it from happening quietly — the rule requires the manufacturer to maintain a record that includes the reason no investigation was made and the name of the individual responsible for that decision. “Nothing to investigate here” is allowed to be the right call. It is never allowed to be a call nobody made.

That is the same discipline this digest script applies to its own quiet weeks, at a much smaller scale and with nothing filed with a regulator. “Nothing material happened” is a legitimate thing for the digest to say. The script simply refuses to let that sentence leave the building without a named person having actually looked at the review queue and agreed with it — the same reason the busy weeks require a paste and a keypress rather than a cron entry.

This is regulatory intelligence about how the pipeline is built, not regulatory advice about your own complaint-handling procedure; §820.198 applies to your quality system, on your facts, and belongs with your own regulatory judgment. See our editorial standards for the rest of what stays human in this product and why.