AI visual inspection · pharmaceutical manufacturing

Inspect every unit. Explain every deviation.

Phamqyra learns each format from good units, catches the particles, cracks and closure defects nobody labelled, and traces every deviation to the batch or component lot behind it — with a record QA can sign.

RUNNING
Simulated
inspection
PASS
PASS
REJECT
PASS
PASS
pass 0reject 0
on-prem inference · frames retained 30 d
Inspection recordbatch 24-0917
  • Awaiting units…
e-record · audit trail on · sha256 per frame
Investigation signal

No correlated pattern in this batch yet.

01Few-shot teaching
A few dozen conforming units teach a new format. No labelled defect library, no rules recipe.
02Zero-shot deviations
Particles, cracks, fill and closure deviations it was never shown — flagged on first occurrence.
03Batch-level root cause
Every deviation tied to batch, line, station and component lot, with a signed audit trail.

Formats inspected

F-01
Liquid vials
F-02
Lyophilised vials & ampoules
F-03
Prefilled syringes & cartridges
F-04
Tablets, capsules & blister
F-05
Bottles & cartons
F-06
Labels & serialisation

01 / Method

Learn. Detect. Investigate.

Three steps that replace a recipe engineer, a labelled defect library and a tired inspection booth on the night shift.

Teach a format from conforming units.

Capture a few dozen good units on your own station, with your own lighting. Phamqyra builds a self-supervised model of what a conforming unit looks like for that presentation — then locks it as a versioned recipe ready for qualification.

  • Few-shot: conforming units only, no defect library
  • One locked model per product, presentation and station
  • Re-teaching is a change-controlled new version
learn · 2R-clear · station 3simulated
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02
03
04
05
06
07
08
09
10
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Model 2R-clear-v7 ready
24 conforming units · self-supervised · sha256 3f9a…c21e
Submit for qualification

02 / Investigation

From “reject” to “here’s why.”

Rejecting a unit is the minimum. Phamqyra charts every deviation class against batch and component events, and tells QA which change explains the shift — while the batch is still on the line.

Visible particle · reject rate per sub-lot
batch 24-0917 · 2,500 units per sub-lot · synthetic data
11 sub-lots above UCL
0.0%0.1%0.2%0.3%0.4%0.5%SL-01SL-06SL-12SL-18SL-24SL-30SL-36mean 0.12%UCL 0.28%stopper lot ST-2291 loaded
Hover to inspect. Draft deviation DR-24-0412 raised at SL-27 · stopper lot quarantine recommended.
Context on every frame
Batch, sub-lot, station, shift and every component lot travel with each inspection result.
Statistical, not anecdotal
Deviation classes run on control charts continuously. A shift above the limit surfaces within the sub-lot.
Closed loop to your QMS
Draft deviations go to QMS, results to MES and LIMS — over OPC-UA, REST or file drop.

03 / Comparison

Manual inspection tires. Rule-based AVI ossifies.

Phamqyra learns each product's normal and keeps learning under change control.

CriterionManual visual inspectionRule-based AVIPhamqyra
Set-up for a new product
Qualify inspectors with defect kits
A recipe engineer per presentation
A few dozen conforming units
Deviation types nobody defined
Sometimes — attention dependent
Only what the recipe encodes
Zero-shot deviation detection
Consistency across a shift
Fatigue limits booth sessions
Consistent, until the product changes
Same model, every unit, every shift
False rejects of good product
Conservative by necessity
Tight thresholds reject variation
Learns conforming variation
Root cause for investigations
Inspector notes, after the fact
Pass/reject counts only
Correlated to batch and component lot
Records for batch release
Paper forms and signatures
Machine logs, limited context
Signed e-records with frame hashes

04 / Compliance

Built for GMP, not retrofitted for it.

AI that QA can actually release: locked, versioned models, a validation package per version, and records that stand up to an inspection.

model lifecycle · 2R-clearv7 released · v8 in qualification
01Teachdraft model · v802QualifyIQ / OQ / PQ evidence03Releasee-signed · locked04Monitordrift · trending05Change controlreason for change0 untracked model changes
Audit trail by default
Every action attributable and time-stamped, with reason-for-change captured. Designed to support 21 CFR Part 11 and EU GMP Annex 11 workflows.
Electronic signatures
Model release, threshold changes and deviation dispositions are signed with role-based approval.
Validation package
URS, risk assessment, IQ/OQ/PQ protocol templates and a traceability matrix ship with every release.
Locked models
A released model does not learn in production. Improvements arrive as new versions through your change control.
Data integrity
ALCOA+ records, sha256 hash per frame, configurable retention, and exports ready for an inspector.
On-prem or air-gapped
Inference and records stay inside your validated network. Nothing leaves the site unless you decide it does.

06 / Pricing

From $200 per camera per month.

Priced as software, not as a capital project. False-reject recovery and fewer investigations show up within weeks — which is why pilots convert.

Per camera

$200
per camera / month

Up to $800 depending on resolution, frame rate and station count.

  • Few-shot teaching, unlimited products
  • Zero-shot deviation detection and maps
  • Inspection records with audit trail
  • Reject signal to the machine over OPC-UA
  • Edge appliance included during pilot

Per line

Most pilots
Custom
per line / month

All stations on a line, batch investigation and system integration.

  • Everything in Per camera
  • Batch and component-lot correlation
  • Draft deviations to QMS, results to MES and LIMS
  • Validation package per model version
  • Named validation engineer during pilot

Site & enterprise

Let's talk
multi-line, multi-site

Air-gapped deployment, CSV support and SLAs.

  • Everything in Per line
  • Air-gapped and segregated networks
  • Computer system validation support
  • Cross-site deviation intelligence
  • Uptime and response SLAs

Pilot pricing and volume discounts available. Camera pricing scales with resolution and throughput; we'll quote after a 30-minute line review.

07 / Questions

What QA asks first.

Validation, data integrity and how it fits the line you already run.

  • Yes — if the model is treated like any other configured system. Each Phamqyra model is locked at release, versioned with the units it learned from, and shipped with protocol templates (IQ/OQ/PQ), a risk assessment and a traceability matrix. A released model does not change in production; improvements arrive as new versions through your change control.

Start a pilot

One station, one product, a few dozen good units.

Pilots run alongside your current inspection, so you see what Phamqyra catches — and what it stops rejecting — before anything changes in your batch record.