Ten steps, about four minutes. You make the decisions; the software
does the arithmetic and keeps the record. Every name, product and detail
below is fictional.
Step 1 of 10 · A complaint arrives
Friday, 4:52pm
A message lands in the support inbox at Northwind Botanicals, a
fictional supplement brand.
support@northwind-botanicals.example · received Fri 12 Jun, 16:52
Hi - I bought your Magnesium Complex last month and took two capsules on
Wednesday evening like the label says. About an hour later I felt really dizzy and
my heart was racing. My husband took me to A&E and they kept me in overnight.
I'm home now and okay. I still have the bottle but I can't read the number on the
bottom, it's smudged. Can you tell me if this has happened to anyone else?
- Dana Whitfield
The clock has already started. Not when someone reads this on
Monday - the reporting clock runs from the moment the information reached the
company. That is Friday at 16:52.
Step 2 of 10 · Recorded as it arrived
Her words, not a summary
The message is kept exactly as received, with where it came from and when. Nobody
tidies it into a sentence.
Source
Support inbox (monitored channel)
Reached the company
Fri 12 Jun 2026, 16:52
Staff became aware
Mon 15 Jun 2026, 09:14
Original wording
Preserved, unedited
Two dates, deliberately. The gap between them is where lateness
hides, so both are recorded and the clock uses the first one.
Step 3 of 10 · Matching the order
Which purchase was this?
She said “Magnesium Complex” and “last month”. Candidate
orders are suggested from that - you confirm which is right.
#NB-10442 · 14 May 2026 ·
d.whitfield@example.com
Magnesium Complex 400mg, 120 caps × 1 -
strong match
#NB-09877 · 3 Mar 2026 ·
d.whitfield@example.com
Magnesium Complex 400mg, 60 caps × 1 -
older, outside the window she described
Suggested, never automatic. A person confirms the match, and the
record shows who did and when. Software guessing at evidence is not evidence.
Step 4 of 10 · What is missing
The lot code is smudged
The confirmed order carries the product and variant. Some fields a report needs are
not there, and the case says so plainly rather than leaving blanks.
Product
Magnesium Complex 400mg - from order
Purchase date
14 May 2026 - from order
Lot code
Unreadable - reporter cannot make it out
Dose taken
2 capsules - from her message
Other medicines
Not yet asked
Clinician seen
Yes - A&E, admitted overnight
“Unreadable” is a recorded answer, not a gap. An
empty field looks like nobody asked. This shows somebody did.
Step 5 of 10 · Follow-up
One message, asking for what is missing
Drafted for you. Nothing is sent automatically - you edit it
and send it yourself.
Draft · not sent
Hi Dana, thank you for telling us, and I'm glad you're home and feeling better.
So that we have a complete record, could I ask three things when you have a moment?
1. If you still have the bottle, a photo of the base - even a smudged code
sometimes reads in a picture.
2. Were you taking any other supplements or medication that week?
3. Did the hospital give you any paperwork or tell you what they thought it was?
No rush at all, and thank you again.
The clock does not stop while you wait. If she does not reply,
the determination is made with what is known, and the attempts to reach her are part
of the record.
Step 6 of 10 · Seriousness
Six criteria, assessed one at a time
Not one judgement called “serious”. Each is considered separately, by a
named person.
Death
Life-threatening experience
✓Inpatient hospitalisation - admitted overnight, per her
message
Persistent or significant disability
Congenital anomaly or birth defect
Intervention required to prevent one of the above
The software did not decide this. It laid out the criteria and
recorded which one a reviewer marked, who they are, when, and on what basis. It will
never make that determination, on any plan, in any version.
Step 7 of 10 · The deadline
A calculation, not a countdown
One criterion is met, so a serious adverse event report is due within 15 business
days. Here is the whole arithmetic - and it stays with the case.
Day 0 Fri 12 Jun 2026
Confirmed by R. Okonkwo, Safety Reviewer
Reason Timestamp on the original support email
Calendar us-federal, version 2026.1
Counting 15 business days from 15 Jun… excluded Sat 13, Sun 14 Jun - weekend excluded Sat 20, Sun 21 Jun - weekend excluded Fri 19 Jun - Juneteenth (federal holiday) excluded Sat 27, Sun 28 Jun - weekend excluded Sat 4, Sun 5 Jul - weekend
Due Mon 6 Jul 2026
Why record the calendar version? If the holiday list changes next
year, this calculation must not change with it. Eight months from now, someone can
see exactly how this date was reached.
Step 8 of 10 · Public FDA data
What is publicly on record
Northwind watches the ingredient names it sells. Two public records mention
magnesium preparations in the last 24 months.
Search term
magnesium (ingredient watch)
Public records found
2 - neither names Northwind
Data retrieved
Today
This proves nothing, in either direction. Public reporting is
voluntary, incomplete and unverified. A match is a prompt to look, never a finding,
and it never shows that a product caused anything. No matches does not mean no
problem.
Step 9 of 10 · Review and submission
Approved by a second person, then filed
The Form 3500A content is assembled from the case. A second named person approves it
- the reviewer and the approver cannot be the same account.
Prepared
From case AE-2026-000118
Assessed by
R. Okonkwo, Safety Reviewer · 15 Jun
Approved by
M. Halvorsen, Regulatory Approver · 29 Jun
Submitted
1 Jul 2026 - 3 business days early
Acknowledgement
Recorded against the case
The app does not file anything. It prepares the content and
records what you submitted, through the route you already use. Submitting is a human
act.
Step 10 of 10 · Eight months later
Someone asks to see the file
A retailer's quality team, an inspector, or your own insurer. This is what exists,
without anyone assembling it from email.
Original message
As received, with its timestamp
When you first knew
Fri 12 Jun, 16:52 - with evidence
Who confirmed Day 0
R. Okonkwo, and why
The deadline calculation
Every excluded day, calendar 2026.1
Seriousness
Six criteria, one met, assessed by a named person
What was asked of the reporter
The draft, when sent, what came back
Every change since
Who, when, why - append-only
Signatures
Attributable to named individuals
That last row is the one a spreadsheet cannot do. A cell shows its
current value. It cannot show what it said before, who changed it, or prove nothing
was altered afterwards.
That is the whole workflow.
It works in a spreadsheet too, if you
are disciplined about it - our operations kit has the checklist, free and with
no signup.
Everything above is fictional. Northwind Botanicals, Dana
Whitfield, the order numbers and the dates are invented for this walkthrough. No real
complaint, person or brand is depicted.