WHY UP↑SCALE › FOR WHOM? › LABORATORIES & PHARMACIES
Laboratory balances with records you can prove
A laboratory has to show that its balances are fit for use, that its records are complete and unchanged, and who did what. UP↑SCALE adds the routine check, the test suite and a tamper-evident audit trail to the balance you already have - for work under ISO/IEC 17025, GLP/GMP and 21 CFR Part 11.
What helps you most
1Routine check before use - along USP <41> and Ph. Eur. 2.1.7
The short check before you work: put a known weight on a few times, the app takes every value by itself and says PASS or FAIL. Profiles for the pharmacopoeias: one weight 10 times, the repeatability as 2 × standard deviation / smallest net weight ≤ 0.10 % (a standard deviation below 0.41 d counts as 0.41 d), accuracy (USP, 0.10 %) or sensitivity (Ph. Eur., 0.05 %) with a weight of at least 5 % of Max - and the minimum weight of your balance (2000 × s). Or your own SOP with your own limits and number of weighings.
A failed check shows a warning until a re-test passes; removing it needs an ADMIN and a reason. The scale itself keeps the interval and the last result, so every device knows when the next check is due. With ENTERPRISE the whole log becomes a sealed PDF report.
The jobs in detail: Laboratory Scale
Manual: routine check
The routine check in detail →
2Users, roles and a reason for every change ENTERPRISE
Up to 50 users with login and password, kept in the scale - the same for every connected computer. Roles: user, operator (may weigh, may change nothing), QM / approver and ADMIN. With strict audit the scale refuses every change without a reason. Passwords never go over the air in plain text: they are encrypted with the key of the scale.
3A tamper-evident audit trail ENTERPRISE
The scale writes an activity log of the last 10,000 events: who weighed, changed, approved or deleted what, when and why - calibration and density changes with the old and the new value. Every entry has a running number and is linked to the one before by a SHA-256 hash chain. The app archives the log while it is connected and saves it as record files that are linked by hash too, with a matching printout. A changed, removed or missing entry shows up when it is checked.
The jobs in detail: Audit Trail & Sealed Records
Manual: how it works, all logs
Part 11, Annex 11, ALCOA+ point by point →
4Numbered reports, sealed by the balance ENTERPRISE
Every printed or saved report gets a running number counted by the scale and an integrity code. The scale seals it: it signs the SHA-256 of the report with its own key (ECDSA P-256) and writes the seal into its activity log. PDF reports, record files and exports are sealed the same way - and anybody can check a sealed file on up-scales.com/check, in the browser, nothing is uploaded.
Manual: the seal of the scale
5Four eyes: recipe approval and signatures ENTERPRISE
A recipe (a weighing procedure) saved by one person must be approved by a QM who did not save it - and with the gate on, only approved recipes can run. Reports get electronic signatures with their meaning (performed, reviewed, approved); the scale checks the password at every signature and logs it.
These are not qualified electronic signatures (no certificate of a trust service).
6The test suite and the calibration date
Repeatability, eccentricity, accuracy and linearity, creep, warm-up and more - along OIML R 76-1 Annex A and EURAMET cg-18, with a checklist per procedure. The equipment register keeps the test interval and the due date, the test history stays on the scale with a trend chart. ENTERPRISE (register, reports)
The jobs in detail: Scale Test Suite
Every test in detail →
7Validation of the calculations (IQ/OQ record) ENTERPRISE
The app carries reference cases worked out by hand from OIML R 76-1 and runs them against its own code - with a fingerprint of the code and the cases. The result is an IQ/OQ record for your own validation file. The cases are public on the check page.
Manual: validation
8And for the bench work
Weigh solvents and chemicals directly in ml (hundreds of densities built in), measure the density of solids, follow evaporation or drying over hours with the tracking mode, and use fine balances down to 0.1 µg steps with every digit (EXACT WEIGHT).
The jobs in detail: Laboratory Scale, Density Scale, Drying & Tracking Scale, Multi-Interval Scale
Audit trail & data integrity in detail → The routine check → The test suite →
Tips from the practice
- Validate your setup: no software is "compliant" by itself - compliance comes from the validated system together with your SOPs. The manual lists exactly what each control does, so you can judge it.
- Keep the record files on read-only, backed-up storage, and keep the fingerprint of the newest file apart.
- Time: the scale has no clock - the time comes from the connected computer; keep its clock right.
- Every user needs a password for strict audit - set it before you switch it on.
The rules you should know
- 21 CFR Part 11 (FDA) and EU GMP Annex 11: electronic records and signatures, audit trail, access control
- ISO/IEC 17025 and GLP / GMP: equipment fit for use, records complete and traceable (ALCOA+)
- USP <41> / <1251> and Ph. Eur. 2.1.7: balances for analytical work - repeatability, accuracy, minimum weight
UP↑SCALE gives you technical controls and records - it makes no claim that you comply with a rule or that an auditor accepts them. Tamper-evident, not write-once: the memory of the scale and files on a disk can still be overwritten or deleted, but that does not go unnoticed. The seal key sits in the flash of the scale (no secure boot). Details and limits: for regulated laboratories, tamper-proof.
Who else works with UP↑SCALE?
Every function is in the same app - these pages only show what matters most for each kind of work. All jobs at a glance: For what?
- Food producers & packers
- Shops, market stalls & farm shops
- Owners of verified trade scales
- Cannabis social clubs (Germany)
- Dispensaries & cannabis shops
- Bakeries & pastry shops
- Coffee roasters & cafés
- Restaurants & commercial kitchens
- Bars & cocktail bars
- Manufacturers & workshops
- Jewellers & gold buyers
- Service technicians & inspectors
- Entrepreneurs & start-ups
- Home cooks & families
- Makers & developers