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Lab balance software with a 21 CFR Part 11 audit trail - on the balance you have
Regulated labs, pharmacies, QA teams and inspectors must show that a balance is fit for use, that every record is complete and unchanged, and who did what. Usually that means a lab software package per balance and a PC next to it. UP↑SCALE ENTERPRISE & COMPLIANCE puts the audit trail, the signatures and the checks into a small device on the RS-232 port of your balance - from any maker.
In short
UP↑SCALE ENTERPRISE & COMPLIANCE is laboratory balance software for analytical and precision balances of any maker with an RS-232 port: users and roles, a hash-chained audit trail kept in the device, electronic signatures, reports and exports sealed by the device that anybody can check on up-scales.com/check, the routine check along USP <41> and Ph. Eur. 2.1.7, a test suite along OIML R 76-1, pipette checks and calibrations along ISO 8655-6, a compounding assistant and a validation pack (IQ / OQ / PQ). Built to the expectations of 21 CFR Part 11, EU GMP Annex 11 and ALCOA+. From 13.00 EUR a month or 599.00 EUR once, 14 days free.
Balance software for regulated work: what you need - and who has it
The usual ways to keep balance records in a regulated lab: the software package of the balance maker on a PC, or a paper logbook with a spreadsheet. Here is what each typically gives you.
| What you need | UP↑SCALE ENTERPRISE | Typical lab package of a balance maker | Paper logbook + spreadsheet |
|---|---|---|---|
| Price | ✓ from 13.00 EUR a month or 599.00 EUR once per device, 14 days free | several thousand EUR per balance, options extra | cheap - but hours of QA work |
| Balances | ✓ any maker with RS-232: METTLER TOLEDO, SARTORIUS, KERN, OHAUS, A&D, RADWAG, SHIMADZU ... | that maker's balances | any |
| Where it runs | ✓ phone, tablet or PC in the browser - the records live in the device at the balance | a Windows PC, often with a database server | paper and a PC |
| Audit trail | ✓ who, when, what and why, old and new value, the last 10,000 events SHA-256 hash-chained, for every connected device | yes, in the PC database | handwritten |
| Electronic signatures | ✓ name, date and meaning, checked by the device and linked to the record | yes | handwritten |
| Proof a file is unchanged | ✓ every report, PDF and export sealed - anybody checks it on up-scales.com/check, no account, no upload | inside the maker's software | none |
| Fit for use | ✓ routine check along USP <41> / Ph. Eur. 2.1.7 with minimum weight, test suite along OIML R 76-1 | often an option | by hand |
| Pipettes and glassware | ✓ checks and calibrations along ISO 8655-6 with uncertainty and a register | usually separate software | by hand |
| Validation | ✓ a validation pack (IQ / OQ / PQ) filled in by the app, with reference cases run on the device | often a paid service | all yours |
| Room and water conditions | ✓ from your sensors (Bluetooth, USB / RS-232, Modbus RTU, HTTP JSON, MQTT) with a register of certificates, due dates, U and corrections, every value with its source; a room log with limits | a separate monitoring system | read off and written down |
| LIMS / ELN | ✓ JSON to a server in your own network or a webhook - weighings, records and the room log; no third-party cloud | often, as an option | typed in |
Typical offers and prices from public price lists (November 2026) - they can change; examples are named on every scale. Brand names belong to their owners; UP↑SCALE is not affiliated with or endorsed by them.
21 CFR Part 11 and EU GMP Annex 11: the technical controls, built in
Everything an audit can expect from a balance and its software is built in. These are the technical controls:
- Audit trail in the scale: who, when, what and why, with the old and the new value, hash-chained, for every connected device (21 CFR Part 11 §11.10(e), Annex 11 §9).
- Access: users with permanent numbers and roles, lockout after wrong passwords, password age, and QM-signed reviews of the access and of the audit trail (§11.10(d), (g), §11.300, Annex 11 §12).
- Electronic signatures: name, date and meaning, checked by the scale and linked to the record (§11.50, §11.70).
- Sealed records: reports, PDFs, record files and exports, which anybody can check on up-scales.com/check (§11.10(b), (c)).
- Time and storage: the device qualification for the clock and the WORM storage, plus the clock guard of the scale with the signed exact time from up-scales.com as its reference.
- Tests and maths: the test suite along OIML R 76-1, the routine check, and the validation of the calculations (IQ/OQ record).
What stays with you is what no product can do for you: your validation, your SOPs, training, checking who your users are, and the storage and time servers that your IT runs. The app brings the forms and templates for these too.
How it saves time:
- For QA: the documents for the binder come out of the app, filled in by the app, sealed and with signature lines: device records, the user access register, the device register, test records, routine check logs, review records and the IQ/OQ record. You need no consultant for the paperwork, no extra validation package and no subscription.
- For the auditor: checking a file takes a minute on the public check page, without an account or an upload. The reviews, the signatures and the log entry of every seal are in the records, so an auditor asks for a certain entry instead of leafing through paper logbooks.
Built to the expectations of 21 CFR Part 11, EU GMP Annex 11, ISO/IEC 17025, GLP and ALCOA+. No software is compliant by itself: compliance comes from your validated system together with your procedures. This is not a certification.
Part 11, Annex 11 and ALCOA+ point by point, with the limits →
The modules for the lab, QA and inspection
All in the same app, on the same device. Each card links to the module in detail - most with a checklist.
Audit trail & data integrity ENTERPRISE
Who, when, what and why in the device, hash-chained - mapped to Part 11, Annex 11 and ALCOA+ point by point.
Daily balance check (USP <41>) FREE+ ENTERPRISE
Repeatability, accuracy and minimum weight along USP <41> and Ph. Eur. 2.1.7 in one minute a day - a failed check warns on every device until a re-test passes.
Scale test suite (OIML R 76) FREE+ ENTERPRISE
Eccentricity, linearity, repeatability and every test of OIML R 76-1 Annex A at the balance, with checklist and a sealed final report.
Pipette check & calibration PROENTERPRISE
Pipettes, dispensers, burettes and glassware of every maker along ISO 8655-6: every value taken by the balance, the uncertainty, a register with due dates.
Compounding assistant ENTERPRISE
From the approved master formula to the signed batch record: lots with use-by dates, in-process controls, four-eyes approval.
📡 Sensors, register & room log PROENTERPRISE
Thermometers, hygrometers and barometers of any maker - on the bench, on RS-485 or in your monitoring system - fill the conditions; the register keeps their certificates and every change is in the audit trail.
Device qualification ENTERPRISE
The clock and the record storage of every PC, tablet and phone - templates, form and a signed record, plus the clock guard of the device.
QA guide & validation pack ENTERPRISE
Introducing it in a regulated lab: the QA tasks, IQ / OQ / PQ, an estimate of the effort, the validation summary report and the release by QA.
For auditors & QA teams ENTERPRISE
Check the records of many balances in minutes: every file checks itself, the reviews and signatures are in the records.
For service technicians & inspectors FREE+ ENTERPRISE
Test the scales of your customers and hand over a numbered test record the device sealed.
More for labs: laboratories & pharmacies in detail (air buoyancy, solutions, US labs, the rules) · security for your IT · free USP <41> minimum weight calculator
In the app: the activity log, the routine check, the seal
Who did what and when, a routine check before use with its verdict, and a sealed file checked on the public check page - real screenshots with demo values.
More about the app, with all screenshots →Screenshots of the real app with demo values - a screenshot may show the look of an older app version.
See the documents before you buy
- Sample validation pack (42 pages, sealed): plan, system, references, requirements, risk assessment, IQ, OQ with the reference cases, PQ and the Part 11 / Annex 11 checklist - PDF or read it in the browser.
- A sealed report - and a changed copy: check both on up-scales.com/check. The sealed lot report is valid; in the changed copy one number differs, and the check shows it.
Made on a test unit with demo values.
Hardware and costs
- The device at the balance: the ESP32-C3 RS232 Adapter (sold by TinyTronics, 13.50 EUR) with the UP↑SCALE firmware - or soon the 232 UP↑SCALER, the boxed professional dongle with 12 months of ENTERPRISE & COMPLIANCE (prototype, about 200 EUR). The records are kept and sealed in the device - so ENTERPRISE needs one; the virtual scale in the browser has no ENTERPRISE.
- LISTEN ONLY and EXACT WEIGHT: the device never sends a byte to your balance and shows its weight exactly as the balance sends it.
- ENTERPRISE & COMPLIANCE: from 13.00 EUR a month, 144.00 EUR a year or 599.00 EUR once, for ever - 14 days free to try on your own balance. Includes everything of PRO.
- What you save: our estimate for one balance is about 12,000 EUR in the first year in validation hours and software subscriptions - the table, with your own hourly rate.
Prices incl. VAT. All prices · Shop · Security: encrypted link, keys, algorithms
Lab balance software and compliance: questions and answers
Is there 21 CFR Part 11 software for an analytical balance without a big lab package?
Yes. UP↑SCALE ENTERPRISE & COMPLIANCE adds the technical controls of 21 CFR Part 11 and EU GMP Annex 11 - users and roles, a hash-chained audit trail, electronic signatures and sealed records - to the balance you already have, through a small device on its RS-232 port. From 13.00 EUR a month or 599.00 EUR once, 14 days free to try.
Does the software make my balance 21 CFR Part 11 compliant?
No software is compliant by itself: compliance comes from your validated system together with your procedures, training and storage. UP↑SCALE brings the technical controls and the documents for it - the validation pack with IQ, OQ test scripts, PQ and a Part 11 / Annex 11 checklist - and says where the limits are. This is not a certification.
Which balances work with it?
Analytical, precision and industrial balances of any maker with an RS-232 port: presets for METTLER TOLEDO, SARTORIUS, KERN, OHAUS, A&D, ADAM, RADWAG, SHIMADZU and more, plus auto-detect. The device only listens and shows the exact weight of the balance, so the balance itself is not changed.
What does the audit trail record?
Who, when, what and why - with the old and the new value - for logins, settings, calibrations, routine checks, reviews, signatures and sealed reports. The last 10,000 events are kept in the device, every entry chained to the one before by a SHA-256 hash, so a changed, removed or missing entry shows up when it is checked.
How can anybody check that a report was not changed?
Every report, PDF and export is sealed by the device with its own key. Open up-scales.com/check and drop the file in: it is checked in your browser, without the app, an account or an upload. Tamper-evident, not write-once: keep the files on read-only, backed-up storage.
Is there balance calibration software for USP <41>?
Yes. The routine check runs repeatability, accuracy and minimum weight along USP <41> and Ph. Eur. 2.1.7 in about a minute, with profiles and a record - a failed check warns on every connected device until a re-test passes. The test suite runs the tests of OIML R 76-1 Annex A (eccentricity, linearity, repeatability ...) with a sealed report. The traceability comes from your calibrated weights.
Can the balance send its results to our LIMS or ELN?
Yes. The app forwards the live weight, the activity log, weighings, sealed reports, the release state of the balance and the room log of the sensors as JSON to a server in your own network or a webhook - no third-party cloud. The activity log catches up by itself at the next connection.
Is there pharmacy compounding software that works with our balance?
Yes: the compounding assistant of ENTERPRISE & COMPLIANCE runs on the balance you have - master formulas approved by a QM, lots with use-by dates (an expired or recalled lot blocks the start), in-process controls and a signed, sealed batch record.
The same app, for other work
Every function is in the same app - at home, in business and in the lab. Your kind of work in detail: For whom? · every job: For what?
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