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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.

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.

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.

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)

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.

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).

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.

READY TO UP↑SCALE YOUR SCALE?

Start with the free version - the board costs under 15 EUR and you may never need more. If you do, unlock PRO once for 46.50 EUR incl. VAT - or ENTERPRISE & COMPLIANCE for 121.30 EUR. Both are once and forever: no subscription, no advertisements, they work offline FOR EVER, updates stay free.