WHY UP↑SCALE › FOR WHAT? › AUDIT TRAIL & DATA INTEGRITY
Audit trail and data integrity for your balances
An auditor asks three things about a balance: was it fit for use, is the record complete and unchanged, and who did what - and why? UP↑SCALE answers them in the scale itself, with a hash-chained activity log, sealed reports and signatures. Here is every control, mapped to 21 CFR Part 11, EU GMP Annex 11 and ALCOA+ - and what stays your part.
Tamper-evident in four layers ENTERPRISE
1The audit trail lives in the scale
Users, roles, protections, the test history and the activity log are kept in the scale, the same for every connected computer - not in one browser. Every change (calibration, settings, users, recipes, test results, reports, sales, stock) becomes an entry: who, when, what and - with strict audit - why. Calibration and density changes keep the old and the new value. Entries can't be edited or deleted; the last 10,000 are kept.
2A SHA-256 hash chain
Each entry has a running number and contains the fingerprint of the entry before it. Change, remove or insert one entry, and every following fingerprint no longer fits - the check shows it. The sales log is a chain of its own.
3Record files, linked by hash
The app archives new entries while it is connected and saves them as record files (SAVE FOR THE RECORDS) with a printout of the fingerprint. Each file names the one before it - a missing or changed file is found by CHECK ARCHIVE FILES. With strict audit the scale stops changes, programs and sales before an entry would be overwritten unarchived.
4The seal of the scale
Reports, PDF files, record files and exports are sealed: the scale signs their SHA-256 with its own key (ECDSA P-256), our licence key vouches for that scale, and the seal goes into the activity log. Anybody can check a sealed file on up-scales.com/check - in the browser, nothing is uploaded.
Manual: tamper-proof in plain words, ENTERPRISE & COMPLIANCE, the seal, all logs
21 CFR Part 11, point by point
Our reading of the controls of Part 11 and what the balance contributes. No software is "compliant" by itself - your validation and your SOPs decide. ✓ = technical control in place, ◐ = partly / with your procedure, ✍ = your part.
| Clause | What it asks (in short) | What UP↑SCALE does | |
|---|---|---|---|
| 11.10(a) | validation | built-in validation of the calculations: reference cases from OIML R 76-1 run against the code, IQ/OQ record with code fingerprint; the validation of your system is yours | ◐ |
| 11.10(b) | accurate and complete copies, readable and electronic | reports as HTML and sealed PDF, record files (JSON), CSV / JSON exports | ✓ |
| 11.10(c) | protection of records for their retention | hash chain, linked record files, seal; the storage (read-only, backed up) is yours | ◐ |
| 11.10(d) | access limited to authorized people | users with login on every connection; a closed scale answers nobody else | ✓ |
| 11.10(e) | secure, time-stamped audit trail of create / modify / delete | activity log in the scale with user, time, what and why, old and new value for calibration and density; the time comes from the connected computer | ◐ |
| 11.10(f) | operational checks (order of steps) | guided recipes and tests, only approved recipes run (gate), strict audit refuses changes without a reason | ✓ |
| 11.10(g) | authority checks | roles operator / user / QM / ADMIN; ADMIN gates for deleting and settings | ✓ |
| 11.10(h) | device checks (valid source of data) | the weight comes from the scale; the seal names the scale; no record from a dead link (the app locks after 1 s without data) | ✓ |
| 11.10(i)-(k) | training, written policies, documentation control | the public manual describes every control; training and SOPs are yours | ✍ |
| 11.50 | signature shows name, date / time and meaning | signatures with the meaning performed / reviewed / approved, name and time | ✓ |
| 11.70 | signature linked to its record | the signature is tied to the hash of the report, checked against the log of the scale and its archive, and sealed | ✓ |
| 11.100 | signature unique to one person | unique user names; the check of the person's identity is yours | ◐ |
| 11.200 | two components: ID and password | user + password, checked by the scale at every signature; passwords encrypted over the air | ✓ |
| 11.300 | password controls | salted hashes; no password ageing, recovery only by an ADMIN - your SOP sets the rules | ◐ |
EU GMP Annex 11 - the main points
| Point | What UP↑SCALE does | |
|---|---|---|
| 4 Validation | validation of the calculations (IQ/OQ record); the system validation is yours | ◐ |
| 5 Data | data from the scale directly - no typing, no copy-paste | ✓ |
| 6 Accuracy checks | the scale checks every sale against its own weight; routine checks and the test suite for the balance | ✓ |
| 7 Data storage, backups | record files with fingerprints, CHECK ARCHIVE FILES; the backup routine is yours | ◐ |
| 8 Printouts | numbered, sealed reports | ✓ |
| 9 Audit trails | activity log with reason (strict audit), chained, archived | ✓ |
| 12 Security | users, roles, gates, encrypted passwords | ✓ |
| 14 Electronic signature | signatures with meaning, linked to the record, checked by the scale | ✓ |
ALCOA+ in practice
| Principle | How |
|---|---|
| Attributable | every entry carries the logged-in user |
| Legible | plain reports, PDF and CSV - and the record files in JSON |
| Contemporaneous | written when it happens, with the weighing - not typed in later |
| Original | the weight of the scale; RS-232 EXACT WEIGHT keeps the value of a verified scale unchanged |
| Accurate | routine check, test suite, validated calculations |
| Complete | running numbers and the chain show gaps; lost entries are recorded |
| Consistent | one sequence per scale, the same for every connected computer |
| Enduring | record files linked by hash - on your read-only, backed-up storage |
| Available | exports any time; anybody can check a sealed file without the app |
Compared with the usual ways
| Balance + paper logbook | Balance + PC software | UP↑SCALE | |
|---|---|---|---|
| Who / when / why | signature on paper | yes, on the PC | in the scale, for every connected device |
| Changes visible | crossed out | depends on the vendor | hash chain + seal, checkable by anybody |
| A PC at the balance | no | yes, with its own validation | no - phone, tablet or any computer |
| Costs | time | licences per seat, often a yearly fee | 121.30 EUR once per scale |
The limits - for your validation
- Tamper-evident, not WORM: the memory of the scale and files on a disk can still be overwritten or deleted - but not unnoticed. Keep the record files on read-only or write-once, backed-up storage, and the printed fingerprint of the newest file apart.
- The log keeps the last 10,000 entries; without strict audit older unarchived ones are overwritten (the lost numbers are recorded).
- For most settings the log records which one was changed, by whom, when and why - but not the old and new value (only calibration and density).
- The time comes from the connected computer - set its clock automatically.
- The seal key sits in the flash of the scale without a secure element: someone with the scale in hand and special tools could copy it (seals made with a copied key have no entry in your archived log). The seal does not prove unchanged firmware.
- Signatures are not qualified electronic signatures (no trust-service certificate) - sign the PDF with your own qualified tool if you need one.
- Recipe approval covers recipes only, not THINGS or settings.
UP↑SCALE gives you technical controls and records - it makes no claim that you comply with a rule or that an auditor accepts them; this is not a certification. All details: for regulated laboratories. The page for laboratories →