Counts you can sign.
Steadeye is the GxP vision system for pharmaceutical counting and inspection. Up to six cameras become one validated station that counts units and flags damaged ones in the same capture. Every result lands in a tamper-evident batch record with electronic signatures and a SHA-256-chained audit trail. One Windows PC. No cloud.
OK
All 160 units found. The frame passes.
One capture. Four verdicts.
These four frames are unretouched evidence images from one capture event on the running station. Every frame gets a verdict, and every verdict has a consequence in the batch record, the PDF report and the PLC handshake.
Every expected unit found. The frame passes and the batch counter advances.
The same station also inspects for damage: switch the check logic and detections in a damaged class mark the frame DAMAGED. Damaged units land in the batch record, the report and the PLC result. Selectable per product run, fully audited.
Built for pharmaceutical production. Ready for any regulated line.
Steadeye is a vision system for pharmaceutical manufacturing, medical devices and every production where counts and inspections have to be documented. Start with the use case closest to yours.
- Pharmaceutical vision systemCounting and damage inspection with GxP-grade evidence, from trigger to signed batch record.
- Tablet & capsule countingUp to six cameras compare every tray with its expected quantity: OK, SHORT, OVER or NO_TRAY.
- GxP & 21 CFR Part 11Audit trail, e-signatures and a GAMP 5 validation kit: what QA needs to qualify a vision system.
Everything a validated station needs. Nothing it doesn't.
Detection and capture
- FS-01
AI detection engine
Current single-stage detector families and end-to-end ONNX exports are auto-detected. The runtime picks the fastest execution provider at startup, GPU or CPU, and logs the choice into the audit trail.
- FS-02
Damage detection
A switchable check logic inspects instead of counts: detections in a damaged class mark the frame DAMAGED, and damaged units land in the batch record, PDF report and PLC result.
- FS-03
Six cameras, one click
USB, RTSP and MJPEG-over-HTTP cameras stream live previews with detection boxes. CAPTURE ALL grabs timestamp-aligned frames from every camera in under a second on GPU.
- FS-04
PLC-triggered capture
Native drivers for the two most common industrial PLC families with a Ready/Busy/Done handshake: a rising trigger bit runs CAPTURE ALL and writes result code and counts back to the PLC.
Records and compliance
- FS-05
Tamper-evident audit trail
Every security, data and settings event lands in an append-only log secured by a SHA-256 hash chain. A built-in verify function re-walks the chain and flags any manipulation.
- FS-06
Electronic signatures
Closing a batch requires re-entry of username, password and signature meaning, 21 CFR Part 11 style. Closed batches are immutable.
- FS-07
PDF batch reports
One export contains every counted frame with its annotated image, per-camera deviations, the parameter snapshot with model SHA-256, operator identities and signatures.
Access and control
- FS-08
Local & Active Directory auth
Switch between bcrypt-secured local accounts and AD/LDAP with group-to-role mapping. Password policy, account lockout and forced first-login change are built in.
- FS-09
Editable role permissions
A permission matrix defines what each role sees and may change, editable in the UI. Safety-critical groups stay admin-only, enforced server-side.
Training and operations
- FS-10
Annotation & in-tool training
Label small objects, including a damaged class, in the built-in annotation tool. Train detection models as a background job and register the ONNX into a SHA-256-sealed registry.
- FS-11
Bilingual UI & operator manual
The interface switches between English and German, with an in-app operator manual one F1 away. Runs in any browser on the station or across the network.
- FS-12
Simulation mode
Synthetic trays with a known object count and a deterministic mock detector let you run the complete workflow without any hardware. Ideal for OQ dry-runs.
The shipped requirements traceability matrix maps every specification item to its qualification test.
The batch record writes itself.
Closing a batch requires username, password and signature meaning, 21 CFR Part 11 style. The signature seals a SHA-256 of the batch content; from that moment the record is immutable.
- Every image is hashed at write time, raw and annotated, per camera, per capture.
- The model is frozen into the record. Its SHA-256 travels with every count it produced.
- One click exports the PDF report with annotated images, deviations, identities and signatures.
Batch record
LOT 2026-0847- Capture events
- 3
- Detected
- 2397
- Expected
- 2400
- Missing
- 9
- Signed by
- admin
- Meaning
- Batch closed — reviewed and approved
- Signed at
- 2.7.2026 22:51:29
content_sha256 460bfc21…c680b20c
Closed
From this moment the record cannot be changed.
Built for auditors, not retrofitted for them.
Every security, data and settings event lands in an append-only log where each entry is chained to its predecessor with SHA-256. Change one byte anywhere in history and verification fails. Even a PLC-triggered capture is attributed, as user 'plc'.
BATCH_CREATED admin, LOT 2026-0847
ffb2cc…280322:46:10prev 000000…0000
CAPTURE_EXECUTED plc, capture #1, 6 cameras
3515b2…318f22:48:02prev ffb2cc…2803
CAPTURE_EXECUTED plc, capture #2, 6 cameras
d9036c…150f22:49:40prev 3515b2…318f
CAPTURE_EXECUTED admin, capture #3, 6 cameras
c3674c…648422:51:18prev d9036c…150f
BATCH_SIGNED admin, reviewed and approved
43ad55…ea8a22:51:29prev c3674c…6484
BATCH_CLOSED admin, record sealed
b8df69…975022:51:29prev 43ad55…ea8a
Chain verified: 6 of 6 entries intact.
Illustration of how entries chain. The real trail of this batch is shown next to it.
Qualification documents in the box.
Qualification templates and a full requirements traceability matrix ship with the system.
- IQ
- Installation Qualification
- OQ
- Operational Qualification
- PQ
- Performance Qualification
- RTM
- Requirements Traceability Matrix
Your objects. Your model.
No vendor round-trips, no per-image cloud fees, no shipping your product photos to anyone. New product, new packaging, new object? Retrain on the station and keep the model. It's yours.
- 1
Label
Box, circle and polygon tools with deep zoom, built for hundreds of small objects per image, including a damaged class.
- 2
Export
Freeze labels into a versioned dataset: open text format, SHA-256 sealed, listed with image and shape counts.
- 3
Train
A cancellable background job fine-tunes a detection model on your objects and exports ONNX. On the station's GPU, or any PC.
- 4
Register
The result lands in a sealed model registry. Activation is audited and blocked during an active batch.
From the operator manual: label images → export a dataset version → train → register the result in the model registry → activate it. Every step is audited.
Your PLC pushes the button. The record still holds up.
One process image and handshake over three transports: native drivers for the two most common industrial PLC families, plus a simulated PLC for validating the integration without hardware. Captures fired by the line are audited as user 'plc', so attribution survives automation.
- PLCsets the TRIGGER bit
- Stationruns CAPTURE ALL into the active batch
- Stationwrites result code and per-camera counts
- Stationraises DONE while the heartbeat keeps ticking
- PLCreads the results and clears TRIGGER
Integration files, generated for you
Download engineering files that already match your configured offsets. No manual address bookkeeping on the PLC side.
- GSDML
- PROFINET device description
- DB source
- PLC data block, matching offsets
- GVL export
- global variable list
Admin-only, test before you trust
PLC settings live in an admin-only section, enforced server-side regardless of the permission matrix. Test the connection before saving, apply and reconnect live, and fire simulated triggers to rehearse the line.
Written for the people who have to qualify it.
Guides on the questions that come up long before a purchase order: what Part 11 expects from a camera system, how counting methods really compare, and how to validate one without writing the documentation yourself.
21 CFR Part 11 for vision systems
The seven technical controls to check before you buy, and the gaps that surface in an audit.
7 min read
Manual, weight-based or camera counting?
How the three methods fail, what evidence each leaves behind, and when to pick which.
8 min read
How to validate a vision system
GAMP 5 categories, the document set, the challenge tests that prove something, and what to do about model changes.
9 min read
From download to counting in one afternoon.
- 1
Download
One signed installer, both editions inside.
- 2
Activate
Paste your license key. Fully offline, no account.
- 3
Count
Open the station in any browser. Cameras, PLC and audit trail are ready.
Counting the same afternoon.
One installer, no dependencies
Steadeye ships as a single Windows setup. Run it on any Win10/11 x64 PC and you get program files, a writable data tree, an auto-start background service and optional HTTPS remote access. Nothing else to install.
GPU without the pain
The bundled ONNX Runtime drives any DirectX 12-capable GPU through the standard vendor driver, with no extra GPU toolchain, and falls back to CPU automatically.
One process to qualify
The whole station is a single audited executable: web server, detection, PLC drivers and database in one process. The bundled proxy adds HTTPS across the network; all data stays on the machine.
License edition
Count
The full production station: counting and damage detection, batch records, e-signatures, PDF reports, audit trail, PLC integration.
License edition
Train
Everything in Count, plus the annotation-to-training pipeline: label datasets, train detection models in-tool and register them into the sealed registry.
Offline, fail-closed licensing
One installer serves both editions; the pasted key decides. Activation works fully offline, the station refuses to start without a valid license, and upgrading Count to Train is a new key, not a reinstall.
Ready to make every count provable?
Try the complete workflow in simulation mode, with no cameras, model or hardware, or book a live demo on your own parts.