QA & compliance brief
QA & compliance brief (system description for qualification)
System description, controls and test evidence of d-dispensing as an input document for your risk-based qualification.
Document status
Draft. This document describes system boundaries, controls and test evidence of d-dispensing as an input document for the operator's risk-based qualification. It is not a validation statement and claims no compliance. Regulatory references at chapter/principle level; have QA/Regulatory review before release. Complete [Engineering] items from README/code.1. Purpose and scope
d-dispensing is a guided dispensing terminal for the manual weigh-out of starting materials against a bill of materials in batch manufacturing (pharma, cosmetics, detergents). It delivers the dispensing record as part of the batch record; it is not an electronic batch record (EBR), not an MES and not a recipe management system.
Division of responsibility
D-Automation provides software, system description, test evidence and change information. Qualification in the operating environment (Annex 15, GAMP 5), assessment against Annex 11 / 21 CFR Part 11, SOPs (including second-person check), master-data maintenance, scale calibration and user management rest with the operator.2. System description
2.1 Components
| Component | Function | GMP relevance |
|---|---|---|
| Site server (1/plant) | ERP/WMS integration, tolerance checks, booking transaction, audit trail, licence check, serves the UI | High – location of decision logic and audit trail |
| Station agent (1/scale) | Scale and printer connectivity, durable local store (outbox), update verification; outbound-only connection | High – origin of the measurement, location of local storage |
| Operator UI (browser) | Display and input | Medium – no decision logic; tolerances enforced server-side |
2.2 Data flow of a weighing
- 01Production order scanned; BOM comes from the ERP (myfactory or weclapp) via the site server.
- 02Position selected; container ID (Quant) scanned; server checks material against position. Refusal → audit trail.
- 03Measurement arrives serially from the scale via the station agent; no manual weight entry.
- 04Finish only within tolerance; server checks independently of the browser.
- 05Order: store durably locally → print label (barcode = record ID) → transmit to server → booking to the ERP (and WMS xstorage, where used) in one transaction → audit-trail entry.
- 06Proof of charging captured in the same record.
2.3 Interfaces
ERP myfactory with WMS xstorage, and ERP weclapp (implemented and tested); serial scales from Mettler Toledo, Sartorius, RHEWA and more, further manufacturers addable in the driver layer; ZPL to Zebra printers. Integration layer (ErpPort) implementation-agnostic; further adapters not available today.
3. Controls
| Control | Implementation | Requirement addressed (principle level) |
|---|---|---|
| Material check before weighing | Container ID against BOM position; refusal logged | EU GMP Ch. 5: correct starting material, check recorded |
| Tolerance enforcement | Server-side: single weighing ≤ 104 % of remaining; position closure 98–102 %; warnings 50 %/95 %. Client displays, server decides. | Manufacturing instruction; Ch. 5 quantity check |
| Attributability | Operator, station, timestamp, scale per record | ALCOA (attributable); Ch. 4 |
| Originality/accuracy | Measurement straight from the scale; no manual entry | ALCOA (original, accurate) |
| Contemporaneity | System timestamp at finish; "trusted timestamps"[Engineering: time source/method] | ALCOA (contemporaneous) |
| Completeness | Refusals, licence checks, updates in the same audit trail | ALCOA+ (complete) |
| Consistency of sequence | Store → label → book; a label cannot claim a non-existent booking | ALCOA+ (consistent) |
| Durability/tamper evidence | Hash-chained audit trail; checkpoints for verification; no rotation, no editing | Annex 11 audit trail; ALCOA+ (enduring) |
| Availability | Built-in export for QA review | ALCOA+ (available); Annex 11 review |
| Failure behaviour | Weighing in progress finishes offline, stored locally, booked idempotently; no new orders offline | Annex 11 business continuity; avoids double booking and stale data |
| Software change control | Ed25519-signed release manifests; signature → size → checksum before install; activation only without open weighing; update logged | Annex 11 change management |
| Network security | Station agent outbound only; server the sole ERP interface | Annex 11 security |
| Licence | Never stops a weighing; 3-week warning, 2-week grace, then no new orders; offline-verifiable | Availability |
| Hazard information | GHS pictograms/signal word from material master on screen during weighing | Workplace safety (CLP, national rules) |
4. Test evidence
- Automated tests: hundreds across server, agent and UI[Engineering: current count, coverage, CI evidence].
- Regression suite against production: reference fixtures from real operation since 2015 ensure that every release reproduces the proven bench behaviour – not just a specification written afterwards.
- Failure tests: offline behaviour (finish, local storage, idempotent replay) demonstrated as a tested property[Engineering: test references].
- Update verification: tests for signature check, size/checksum verification and rejection of tampered responses[Engineering: references].
Test reports and release notes are provided per version for supplier assessment.
5. Known limitations and open items (as of September 2026)
This list is part of the document because a qualification needs it:
- Uptime and reliability figures are not published as metrics; operating history since 2015 on request.
- Manual installation; signed Windows installer (MSI, code signing) not available.
- Updates without automatic restart: new version takes effect at the station's next manual start.
- Licensing off by default; never stops a weighing by design.
- Two ERP integrations implemented: myfactory (with WMS xstorage) and weclapp; no further adapters today.
- GHS pictogram set incomplete: GHS04 and GHS07 currently missing from the shipped assets[Engineering: status]. Display capability exists; full coverage is not claimed.
- Migration from an existing terminal: methodology (pilot bench, comparison of records, cutover) is developed per project with the operator.
- Electronic signatures / in-system second-person check:[Engineering: clarify scope] – until then the second-person check is governed organisationally (SOP).
6. Suggested qualification approach (GAMP 5-oriented)
- 01Supplier assessment: this document, test evidence, D-Automation's development and change process.
- 02User requirements (URS) compared against section 3; close gaps (e.g. second-person check) organisationally.
- 03Risk assessment: prioritise functions with direct impact on product quality (material check, tolerance, audit trail, failure behaviour).
- 04IQ: installation per the administration guide; document configuration (especially tolerance parameters).
- 05OQ: positive/negative tests at the station – wrong container, finish at 97 %, partial quantities, network interruption during weighing, label–record linkage, audit-trail export.
- 06PQ: pilot operation at one bench with a defined leading record; comparison with legacy/paper.
- 07Periodic review: audit-trail review, update history, licence events.
7. Glossary
See the separate Glossary page (English – German).
Version: draft 0.1, September 2026. D-Automation GmbH.
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