WHY UP↑SCALE › FOR WHAT? › QA GUIDE: INTRODUCING IT IN A REGULATED ENVIRONMENT
Introducing UP↑SCALE in a regulated environment: what your QA team does - and what the app does for it
A short list of the tasks, what is already done for you, what it costs compared with the usual way, and the steps from the order to the sign-off. Written for QA teams in GMP, GLP, ISO/IEC 17025 and similar settings.
What a QA team has to do - and how much the app takes over ENTERPRISE
Putting a connected balance into regulated use is a small validation project. These are the usual tasks. ✓ = done by the app, ◐ = the app prepares, runs or checks it and you decide or sign, ✍ = your work.
| Task | What the app does | Part |
|---|---|---|
| Supplier and IT assessment | No cloud, no accounts: the data go only by Bluetooth LE from the scale to your browser, never over the internet (also with the online app). Nothing to audit at a data centre. | ✓ |
| Intended use, risk assessment | Manual and the limits list give the input. | ✍ |
| IQ / OQ of the software maths | Reference cases worked out from OIML R 76-1, run in the app, record with code fingerprint. | ✓ |
| Test and routine checks of the balance | Test suite, routine check (USP <41> / Ph. Eur. 2.1.7 profile), register with due dates, sealed reports. | ◐ |
| Users, roles, passwords | Roles (ADMIN, QM, operator), password rules, lock-out, access register. | ◐ |
| Audit trail, archive, review | Hash-chained log with old / new value, user and reason; archive rounds; signed review records. | ◐ |
| Device qualification (clock, storage) | Form that fills itself in, templates for Windows, Linux, Android, macOS. | ◐ |
| Long-term storage (write-once) | Record files that prove themselves; the storage is yours. | ✍ |
| SOPs, training, sign-off | Forms and reports to quote or attach. | ✍ |
We don't give a percentage: how much of your own validation work this replaces depends on your procedures. The table of the next section shows an estimate of the hours.
What it costs - the usual way and with UP↑SCALE
Our estimate, not a measurement and not a quote. The hours and subscription prices are typical orders of magnitude from our experience with such projects (no brand names, no price lists); yours will differ. Everything below is for one workplace with one scale, the last table also for a typical workplace with 5 scales. Change the hourly rate to your own.
1. The first time (one scale)
| Task | Usual | UP↑SCALE | Part |
|---|---|---|---|
| Supplier / IT assessment No cloud, no account: all data go only by Bluetooth LE from the scale to the browser on your device, never over the internet. No data centre to audit; you read the open protocol and the check page instead. | 10 – 30 h | 1 – 3 h | ✓ |
| User requirements and risk assessment Yours: the intended use, which records are GxP-relevant. Our manual, the Part 11 / Annex 11 table and the limits list are the input. | 8 – 16 h | 6 – 12 h | ✍ |
| Software maths: IQ / OQ record One button on the TEST page runs the reference cases (OIML R 76-1) and makes the record. You read and sign it. | 15 – 20 h | 0.5 – 1 h | ✓ |
| Metrological qualification of the scale The test suite and routine check run in the app, results are saved and sealed. You still need test weights, a person and acceptance criteria. | 8 – 16 h | 4 – 8 h | ◐ |
| Users, roles, passwords Roles, password rules, lock-out and the access register are built in; you decide who gets which role. | 6 – 10 h | 1 – 2 h | ◐ |
| Audit trail and records set-up Log, archive and record files run by themselves. You only choose the review interval and the reviewer. | 10 – 20 h | 1 – 3 h | ◐ |
| Device qualification (PC, tablet, phone) The form fills itself in; the tester runs the checks and signs. | 4 – 8 h | 2 – 4 h | ◐ |
| SOPs and training Always yours; our texts and forms can be quoted. | 12 – 24 h | 10 – 20 h | ✍ |
| Final report and sign-off The reports come sealed; the QA head signs. | 4 – 8 h | 2 – 4 h | ◐ |
| Total effort | |||
| Total at your rate | |||
| Saved (about) | |||
2. Every year again (one scale)
Re-validation after updates, periodic reviews and re-qualification. The weighing with test weights stays your work in both columns.
| Task per year | Usual | UP↑SCALE |
|---|---|---|
| Software re-validation after updates | 8 – 12 h | 0.5 – 1 h |
| Metrological re-qualification and routine-check records | 8 – 16 h | 4 – 8 h |
| Review of user access | 3 – 6 h | 0.5 – 1 h |
| Review of the audit trail, archive check | 6 – 12 h | 1 – 2 h |
| Device re-qualification | 2 – 4 h | 1 – 2 h |
| Periodic report | 4 – 8 h | 1 – 2 h |
| Total effort | ||
| Total at your rate | ||
| Saved per year (about) | ||
3. Software and hardware per scale
| Per scale and year | Usual | UP↑SCALE |
|---|---|---|
| Balance / lab data software with audit trail and user management Licence or subscription, per scale or workstation | 600 – 1,800 EUR | None. One licence for the scale, no subscription: 149.90 EUR once incl. VAT (ENTERPRISE & COMPLIANCE). |
| Calibration / equipment management software Share for one scale | 400 – 1,200 EUR | |
| Document / validation management (eQMS) Share for one scale | 300 – 900 EUR | |
| Records archive and review / signing tool Share for one scale | 200 – 600 EUR | |
| Subscriptions per year | 0 EUR | |
| Hardware, once | Terminal or balance with the compliance functions - by quote | about 13.50 EUR for the adapter board (ESP32-C3 RS232 Adapter) on your existing serial scale, plus the PC / tablet / phone you already have |
| Updates | Renewals, re-validation | Every update is your decision and needs your impact assessment (hours in table 2). |
4. The sum: 1 year and 5 years
"1 year" = the first time + one year of repeat work and subscriptions; "5 years" = the first time + five years. UP↑SCALE side includes the licence (149.90 EUR) and the adapter (13.50 EUR) once per scale. For 5 scales the supplier assessment, the risk assessment and the SOPs are counted once for the workplace, everything else per scale. Middle of the estimated ranges.
| Usual | UP↑SCALE | Saved | |
|---|---|---|---|
| 1 workspace / 1 scale | |||
| 1 year | |||
| 5 years | |||
| Typical workplace: 5 scales | |||
| 1 year | |||
| 5 years | |||
The big saving is the hours, not the licence. Prices of UP↑SCALE from the shop, incl. VAT, as of today; all hours and the prices of the usual way are our estimates. Not included on either side: test weights, your own devices, your storage.
The steps: from the order to the sign-off
1Decide the use and the risk yours
Which scale, which records are GxP-relevant, who works with it. Read the manual section for regulated laboratories and the Part 11 / Annex 11 table; note the limits in your risk assessment.
2Get the system and freeze the version
Order the ENTERPRISE & COMPLIANCE licence for the Device ID of the scale and flash the firmware you validate. The data never leave the Bluetooth link between scale and browser, online app or offline app alike. To freeze the app version, use the offline single-file app of that firmware version (the online app only changes when you click the update button). Note app and firmware version in your validation plan.
3Qualify the devices ENTERPRISE
Every PC, tablet or phone that runs the app: run the device qualification (clock from a time server, no changes by operators, record folder), sign the sealed form. Until a device is qualified the scale can refuse changes and sales from it.
4Set up users, roles and the protections ENTERPRISE
Create the first user (ADMIN, with a password), then the QM users and operators. Switch on the protections and strict audit (every change needs a reason; every user needs a password). Keep the user access register and sign its first review. Document who has which role in your own matrix.
5Run the software validation ENTERPRISE
TEST page, validation box at its end: run the reference cases, save the IQ/OQ record, have it reviewed and signed.
6Qualify the scale itself
With your test weights: the test suite (strict procedure along OIML R 76-1 Annex A where you need it), set the interval and the due date in the register, choose the routine-check profile and its limits. Save the sealed reports.
7Define the archive yours
The app archives the activity log while it is connected and saves record files. Decide where they go: write-once or read-only, backed-up storage; keep the SHA-256 fingerprint of the newest file separately. Test restoring and checking a file on the check page.
8Write the SOPs and train yours
At least: commissioning of devices; routine check (when, limits, what on a FAIL); user management (who assigns roles, password rules, leavers); change control for firmware and app; archive and restore; periodic review of the access and of the audit trail.
9Sign off
The QA head signs the validation report with the sealed records attached: on paper, or with your own qualified signature tool (the signatures in the app are not qualified electronic signatures). Then release the scale for use.
In operation
- Every day (or by your SOP): the routine check; a FAIL shows a warning until a pass or a documented removal.
- At the interval you set: the test suite; the register shows what is due.
- Regularly: review the user access and the audit trail in the app (signed), save the record files, check the newest one.
- On every update of the firmware or the app: your change control; run the validation box again and keep the record.
- When people leave: remove or lock the user; the log keeps who they were.
The limits, said plainly
- No certification: UP↑SCALE gives technical controls and records built along OIML R 76 / USP <41> / Part 11 / Annex 11 ideas. It makes no claim that you comply with a rule or that an auditor accepts it.
- Tamper-evident, not write-once: changes and gaps are noticed, but files on a disk can be deleted. Write-once storage and the second copy are yours.
- Time comes from the connected device (the scale has no clock): hence the device qualification.
- The seal shows the file is unchanged and which scale it came from, not that the firmware of the scale is genuine.
- Not a legal-for-trade approval: the test records are self-checks and test records, not a verification.
- Electronic signatures in the app are not qualified signatures.
More: Auditors & QA teams · Laboratories · Check a file.
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.
Device qualification: clock & storage
No clock in the scale, no WORM disk? Lock the time and the storage of every device - with templates, form and a signed record.
Scale test suite
Every test of OIML R 76-1 Annex A at the scale, with checklist and final report.