WHY UP↑SCALE › FOR WHAT? › DEVICE QUALIFICATION: CLOCK & STORAGE
No clock in the scale, no WORM disk? Close both in an afternoon
Every FDA, GMP or ISO audit asks two things about a connected balance: where does the time come from, and can the records be deleted? The answer is a short procedure of yours - and UP↑SCALE has the tools for it built in: templates for your IT, a qualification form that fills itself in, a sealed record for your binder that you sign electronically and a device register on the scale.
The two questions of every audit
1Where does the time come from?
The scale has no battery-backed clock: the time of every record comes from the phone, tablet or PC that runs the app - the device. An auditor wants to see that this time comes from a time server and that operators can't change it to backdate a record. Your answer: the clocks of the devices are synchronized and locked, and you recorded it (time integrity, ALCOA+ "contemporaneous", 21 CFR 11.10(e)).
2Can the records be deleted?
Our records are tamper-evident: hash chain, record files linked by hash, the seal of the scale - a change or a gap shows up. But a file on a disk can still be deleted. Real write-once (WORM) is a feature of the storage, never of an app. Your answer: every record goes straight to write-protected storage, and you recorded it (record retention, 21 CFR 11.10(c), EU GMP Annex 11 point 7).
Both are the same for every connected balance and every software - not a gap of UP↑SCALE, but a part of every validation. The difference: here the tools to close them are in the app.
Three steps ENTERPRISE
1Your IT applies the templates
The app writes ready-made settings, filled with your time server and your records folder: a Windows .reg file (browser policy, time server, the hidden Date & time page), Linux (chrony / timesyncd, Chrome policy), an Android MDM policy (automatic time enforced, developer options off), macOS, and the browser policy as JSON: developer tools off, the download folder = your records share, no incognito, no new profiles, no extensions. The app never changes your systems - they are templates for your IT, best rolled out by Group Policy or MDM. free
2The tester runs the form on every device
One form per device, with the tests of its system. Every test has its command with a COPY button; paste what the command printed, and the app proposes PASS or FAIL (it reads "Operation not permitted", "System clock synchronized: yes", a time source that is not the local CMOS clock - also the German and Spanish messages). Clock checks against the scale and a live reference clock, a test file for the records folder, and the storage tests (delete, overwrite, retention, second copy). The tester decides every result. free
3QA signs the record - the scale keeps the register
SAVE SEALED PDF makes a numbered PDF sealed by the scale, with lines for the printed name, signature and date of the tester and the QA reviewer - and both sign it electronically right after saving (performed / reviewed), with their password, which the scale checks every time and writes into its log. The scale enters the device in its device register with the due date of the next qualification. With strict audit, a device that is not qualified can't change settings or book sales. ENTERPRISE
Manual: station qualification, time per system, record storage, register, clock guard
The checklist
What the form tests - run every test as the operator of the device, not as an administrator. ✓ = the app reads or proposes it, ✍ = the tester looks.
| System | Test | Expected | |
|---|---|---|---|
| Windows | operator is no administrator: whoami /groups | not in Administrators | ✓ |
| Windows | set the time / the time zone: time, tzutil /s | "A required privilege is not held" / access denied | ✓ |
| Windows | time source: w32tm /query /source | your time server - not "Local CMOS Clock" | ✓ |
| Windows | Date & time page, BIOS / UEFI password | hidden or locked; password set | ✍ |
| Linux | groups, date -s, timedatectl set-timezone, set-ntp false | no sudo / wheel; "Operation not permitted"; admin password asked | ✓ |
| Linux | timedatectl status, chronyc sources | synchronized: yes, NTP service: active, your server | ✓ |
| Android | Settings app, automatic time and time zone, developer options, restart offline | blocked or locked by the MDM; the time corrects itself | ✍ |
| macOS | groups, date 1200, Date & Time, startup security | no admin; "Operation not permitted"; automatic | ✓ |
| Browser | chrome://policy, F12, incognito / guest / extensions | DevTools off, download folder = records folder; blocked | ✓ |
| Clock | this device against the scale; against a reference clock; time zone; clock jumps since the last qualification | ≤ 5 s; ≤ 2 s (your limit); the site; none | ✓ |
| Storage | test file lands in the records folder; delete / overwrite as operator; retention lock; second copy | without a dialog; refused; set; present | ✍ |
| Storage | newest record file and its fingerprint; browser storage persistent | fingerprint in your binder; yes | ✓ |
The settings behind it, per system: time integrity in the manual and record storage. Check the steps against your own systems - names of policies and menus change between versions.
Filled in for you
Most of a qualification record is typing what is already known. The app does it, read at the moment of the test:
- The device: its ID, browser and mode (installed app, tab, offline file), time zone, app version, the logged-in user - and a system proposed from the browser.
- The scale: name, firmware, Device ID, serial number, licence, certificate data, last calibration, the calibration and configuration counters, the last passed routine check.
- Its data-integrity setup: users and roles (and whether everybody has a password), strict audit, the protections, the device register, heartbeat lock, tare guard, EXACT WEIGHT, the seal key and its certificate.
- The clock: this device minus the scale, clock jumps since the start of the scale, and every jump the scale logged since the last qualification (from the archived activity log).
- The archive: the state of the activity-log archive, the newest record file with its SHA-256 fingerprint, persistent browser storage and its use.
- Remembered per device: asset ID, location, time server, records folder, kind of storage, retention - a re-qualification only needs the tests again.
- People: tester and QA reviewer picked from the users of the scale (name and title).
What the auditor gets
| Part | Content |
|---|---|
| Header | your company and logo, report number counted by the scale, date, user |
| 1 Device | asset ID, location, system and version, time server, records folder, kind of storage, retention, second copy, linked scale with serial number |
| 2 Read by the app | device, scale, data-integrity setup, archive and storage - as listed above |
| 3 Tests | per group: number, action and command, expected, observed (the pasted output), result |
| 4 Result | QUALIFIED / NOT QUALIFIED, the deviations with the action taken, the next qualification |
| 5 Signatures | lines for the printed name, signature and date of the tester and the QA reviewer, and their electronic signatures (performed / reviewed: name, time, meaning, checked by the scale) in the signed report file |
| Footer | integrity code, the seal of the scale, the address of the public check |
| Attached | the HTML report, all pasted outputs as text, the form as JSON |
The PDF is sealed by the scale: anybody checks it on up-scales.com/check, in the browser. The blank paper form (all systems, tick boxes) is free - for a site that wants to start on paper.
Many devices? One register
A scale is often run from several devices - the PC in the lab, a tablet at the bench, the phone of the QA. Each is a device and gets its own record. The scale keeps the device register: the same list for every app, up to 50 devices, with system, state, date, due date, report number and who saved it.
- Add a device: run the form on it - the signed PDF enters it.
- Re-qualify: every 3, 6, 12 or 24 months; a due device is marked due.
- Remove a device: RETIRE with a reason (replaced, broken, lost, not used any more) - it stays listed, because older records were made on it. Nothing is ever deleted.
- Enforced with strict audit: a device that is not qualified (or due) can weigh and print, but the scale refuses its changes and sales; a sale is kept and sent again after the qualification.
- The register as a signed PDF with all devices and the device events and clock jumps from the archived log - one page for the binder.
- The clock guard of the scale: a time that differs by more than 2 minutes from the running time of the scale is written to the activity log - with strict audit the scale keeps its own time.
Effort and costs
| Usual way | UP↑SCALE | |
|---|---|---|
| Validation documents for the devices | written by hand or bought as a package | form, templates and record in the app |
| Typing the system data | by hand, per device | read by the app |
| Judging the command outputs | by eye | proposed by the app, decided by the tester |
| List of qualified devices | a spreadsheet | the register on the scale, the same for every app |
| Costs | consulting days, often per seat | 149.90 EUR once per scale - the form, the blank paper form and the templates are free |
Still your part: your IT applies the settings and runs the storage, your QA signs and keeps the SOP. Less work - not none.
The limits - for your validation
- Tamper-evident, not WORM: the app can't make a disk write-once. The WORM part is your storage (WORM folder, immutable snapshots, object lock); a folder that is only write-protected by rights can be changed by an administrator.
- The time still comes from the devices: the qualification shows that they are locked and synchronized; the clock guard of the scale shows big jumps (more than 2 minutes), not small ones. After a restart of the scale the first app that connects sets its time again.
- A device is a browser profile with a random ID, not a hardware ID - the asset ID on the record and your SOP tie it to the device; block new browser profiles with the policy.
- Templates are templates: names of policies and menus change with the versions of the systems - your IT checks them. The app proposes results; the tester decides and signs.
- The register holds 50 devices per scale (the oldest retired one is reused when it is full). A retired device can be taken off the list to keep it clean - at once while the scale has no users, with users by an ADMIN or QM 12 months after the retirement. The removal is logged in the chained activity log.
UP↑SCALE gives you tools and records - it makes no claim that you comply with a rule or that an auditor accepts them; the record is your own qualification, not a certificate. All details: device qualification in the manual. Audit trail & data integrity → The page for laboratories →
More in detail
All jobs in short: For what? · your kind of work: For whom?
Cannabis club documentation (KCanG)
The workflow and a checklist of every record point - done while weighing.
Audit trail & data integrity
21 CFR Part 11, EU GMP Annex 11 and ALCOA+, point by point - with the limits.
Scale test suite
Every test of OIML R 76-1 Annex A at the scale, with checklist and final report.