End paper labels in your cleanroom
Digital room status with an Annex 11-compliant Audit Trail
An E-Ink display at each room, a status board for the shift lead, full history for your validation team. A 4-week pilot — without an 18-month MES program.
Easy mounting: no drilling, no cabling — optionally on a magnet or 3M double-sided tape.
A paper label is a risk you do not want before an audit
In pharma plants, room status — in use, to be cleaned, QA-released — is still typically a card in a plastic sleeve on the door. Easy to change, easy to forget, easy to lose. The consequences are serious:
Cross-contamination
An operator enters a room that someone forgot to release after the previous product.
Annex 11 non-compliance
No Audit Trail, no electronic signature, no record of who, when, why.
Operator time wasted
Paperwork for every status change, manual transcription into the batch record.
Audit = stress
Reconstructing six months of room history means digging through an archive of paper labels.
Three pillars of the solution
One display at the room. One dashboard for the zone. A full trail for validation.
Dashboard
- A single view of every room in the production zone.
- Top-level status colors match your plant's GMP procedure.
- KPIs: room availability, average time between batches, longest stops.
- Wall TV in the break room, manager's office, or dispatch — no login required.
Operator panel
- An E-Ink display on the wall or door frame of the production room.
- Operator login via card, barcode, or username.
- Two-click status change — with a forced second-person signature where the procedure requires it (line clearance, QA release).
- Product selection from the list assigned to the room.
- Offline-friendly: loss of network does not block a status change.
Audit Trail and configuration
- Every change — status, user, permission, configuration — recorded with who, when, old value, new value.
- Immutable records, PDF and CSV export for the auditor.
- Admin panel for the validation team: rooms, statuses, products, roles, operator lists.
Designed to the standards: Annex 11, 21 CFR Part 11, GAMP 5, ISO 27001
AndonCloud takes its role as a GMP computerized system seriously. We do not sell an app — we sell a validatable module ready for FDA, EMA, and GIF audit.
Requirements covered out of the box
- Second-precision Audit Trail with ALCOA+ fields.
- Access control: roles, permissions, password policy, account lockout.
- Electronic signature: single and dual (four eyes).
- Backup in the protocol of your choice (S3, Azure, OneDrive, Google Drive, FTP, ssh/scp, rclone, WebDAV).
- Documented and testable disaster recovery procedure.
- GAMP 5 category 4 classification (configurable system).
Validation document pack included with the deployment
- System description (architecture, data flow, hardware requirements).
- DSP — vendor's response to your URS.
- TSP — technical and configuration specification.
- Functional test (FAT) protocols and reports.
- Technical infrastructure specification.
- User and administrator manuals.
- Backup and recovery procedure.
From paper labels to a validated system in 4 stages
We map together: rooms, primary and extended statuses, the product list, user roles. You get access to the admin panel and the Status Board.
We install an E-Ink display by the selected room (typically initial weighing or mixing). First-shift operators train and run it across 5 production days. Daily feedback sessions.
We run IQ/OQ protocols jointly with your validation team. The validation document pack reaches its final version. Your QA signs the internal release.
Scale-up to the remaining rooms in the zone. Integration with the Status Board in the manager's office. Change-control procedure in place for future changes.
We map together: rooms, primary and extended statuses, the product list, user roles. You get access to the admin panel and the Status Board.
We install an E-Ink display by the selected room (typically initial weighing or mixing). First-shift operators train and run it across 5 production days. Daily feedback sessions.
We run IQ/OQ protocols jointly with your validation team. The validation document pack reaches its final version. Your QA signs the internal release.
Scale-up to the remaining rooms in the zone. Integration with the Status Board in the manager's office. Change-control procedure in place for future changes.
Customers whose production model we know best
- Drug manufacturers (Rx, OTC)
- Powder zone, sterile, packaging. Weighing, mixing, granulation, tableting, blistering. Full Annex 11 regime.
- Biotech and biologics
- Classes A–D, laminar flow, isolators, fill & finish. CSV validation and full access control required.
- Medical devices (ISO 13485)
- ISO 14644 class 7/8 cleanrooms, controlled-environment assembly, sterilization. Aligned with MDR and FDA QSR.
- Cosmetics (ISO 22716)
- Filling and packaging zone, cosmetic-GMP production. Often light validation — but Audit Trail still required.
- Veterinary (Vet-GMP)
- A regime that mirrors human pharma. Often smaller plants where a heavy MES is not economically justified — our sweet spot.
Cleanrooms in other industries
AndonCloud is also a fit wherever ISO 14644 enforces environmental control:
Semiconductors / microelectronics
ISO class 1-4, wafer fabrication and IC packaging
Medical devices
ISO 13485, implants, biosensors, sterile packaging
Optics and precision instruments
Lenses, satellite components, R&D-grade lasers
Aseptic food packaging
UHT dairy, infant formula, aseptic juices
What your plant gains in the first year
−70%
Time spent on labels — operators change status in 5 seconds instead of 2 minutes of paperwork.
0
"Missing label" findings — auditors get a full history, not a hunt through paper cards.
+100%
Visibility for the production manager — real-time view of where the bottleneck is.
* Figures based on pilots at Polish drug manufacturers. We will calculate your ROI during the demo.
Plugs into what you already run
AndonCloud is API-first. Room statuses can be enriched with ambient data and used by upstream systems.
MES / eBR
Körber PAS-X, Siemens Opcenter, Apprentice Tempo, Tulip, MasterControl, in-house systems (REST API)
ERP
SAP, Comarch ERP XL, Comarch Optima, Microsoft Dynamics
LIMS
Labware, LabVantage, in-house
EMS / BMS
Siemens Desigo, Honeywell, Schneider EcoStruxure — auto-quarantine on environmental excursion
User identity
Active Directory, SAML SSO, OIDC, proximity cards, barcodes
Balances and label printers
Radwag, Sartorius, Mettler Toledo, Zebra (via LAN/USB gateways)
FAQ
Frequently asked questions
- Yes. We deliver a documentation pack (system description, DSP, TSP, tests, infrastructure spec, user manual, backup procedure) plus a full Audit Trail. IQ/OQ/PQ validation is on the customer side — we provide templates and support the execution.
- Both. Cloud: EU hosting, GDPR-compliant. On-premise: installation inside your network, accessed via browser and E-Ink display. The choice affects validation — we advise during the demo.
- For GMP customers we deliver a validated-release track. Updates land first on your staging environment with a full release-notes and impact-assessment pack. Production rollout only after validation team approval.
- Automatic daily backups in the protocol of your choice. The DR procedure is documented and tested annually. The customer receives the test report.
- The operator's E-Ink display works locally for up to 24 hours. Once the network returns, changes sync with the event timestamp (not the sync timestamp) — the Audit Trail stays trustworthy.
- Yes — we map the interfaces during discovery. Most integrations take 2–6 weeks. Complex projects (e.g. eBR integration with an existing MES) are scoped separately.
- Annual subscription per room. Low barrier to entry — a 1–3 room pilot fits inside a production manager's operational budget, no CapEx needed. Details after a short discovery call.
- The system supports controlled electronic signatures and an Audit Trail consistent with Part 11. Full Part 11 validation requires additional customer-side testing — we support you through it.
- Operator interface in Polish and English. Technical support 8–17 in PL; 24/7 SLA with response time per contract.
Manufacturers who trust us
