Machine Overview
SENTINEL 01 · Operator interface concept
Sample inspected
0 / 315
Illustrative inspection
Accepted units
0
All required checks passed
Flagged units
0
Queued for QA review
Nominal capacity
~100k
Tablets/hr design target · not measured here
Active inspection profile
ProductRound 10 mm · White
ProfileIP-DEMO-001 / Rev A
Sample plan315 units · Illustrative
Change partsNot verified
Machine & control boundary
GuardLogix PLCNOT CONNECTED
Vision stationsSIMULATED
Door interlocks / STONO LIVE INPUTS
Physical RUNRequired on production machine
This demonstration cannot energize motion, issue safety commands, or make a GMP batch-release decision.
Inspection Workflow
Guided operator sequence · illustrated electronic sampling
1 · SETUP
2 · VERIFY PARTS
2.5 · QA PLAN
3 · INSPECT
4 · REVIEW
Batch identification
IP-DEMO-001 · Rev A ● Approved (simulation)
Inspection plan
WorkflowOff-line AQL sample inspection
Sample size315 units
Sampling locationsBeginning / middle / end
CriteriaPer approved customer QA profile
The initial 315 is an illustrative demonstration size, not a universal AQL requirement. Actual sample plans and acceptance numbers depend on the customer's approved method.
Products & Recipes
Representative solid-dose formats · controlled recipe concept
Commercial recipe controls
Product master & revisionControlled
Vision configuration & calibrationValidated machine method
Format/change-part associationIdentity + revision check
Approved inspection profileCustomer QA approval required
Quality / AQL
Approved Inspection Profile — illustrative QA-owned specification
Approved Inspection Profile
Profile revisionIP-DEMO-001 / A
StatusAPPROVED · DEMO
SamplingBeginning / middle / end
Illustrative sample315
Defect classesCritical / major / minor
QA responsibilityPlan, criteria, approval, disposition
Approved profiles are immutable in the intended commercial design. Changes create a new controlled revision; demonstration profile here has no real approval.
Responsibility boundary
Customer QualitySpecifications + final batch decision
Fulcrym systemRepeatable inspection execution
Evidence serviceCounts, images, events, reports
Acceptance numbersDefined by customer-approved plan
Sample counts, threshold values, and depicted defects do not demonstrate sensitivity, specificity, or validation.
Batch Records & Evidence
Electronic inspection package concept · illustrative data only
| Batch | Format | Sample | Flagged | Profile | Status |
|---|---|---|---|---|---|
| DEMO-WAHID-001 | Round 10 mm | 315 | — | IP-DEMO-001/A | QA review required |
| DEMO-1020-B | Oblong caplet | 315 | 0 | IP-DEMO-002/A | Example closed |
Example evidence manifest
Batch + recipe revisionLINKED
Profile / sample locationLINKED
Individual sample decisionsSIMULATED
Inspection imagesPLACEHOLDERS ONLY
Electronic signatureNOT IMPLEMENTED
QA disposition
Batch disposition is intentionally NOT simulated as an automatic release. Customer QA owns investigation, review, and approval.
PENDING QA REVIEW
This is a sales demonstration, not a validated or Part 11-compliant electronic batch record.
Diagnostics / Service
Restricted engineering functions concept
Machine communications
Galaxy Tab HMIDEMO DISPLAY ACTIVE
Advantech UNO servicesNOT CONNECTED
GuardLogix / CIPNOT CONNECTED
Kinetix 5300 servoNOT CONNECTED
Basler camerasSIMULATED
Safety interlocksNO LIVE STATUS
Production architecture guardrails
Operator and service privileges must be distinct. The local HMI may request approved operations but cannot replace hardwired emergency stops, PLC permissives, safety-rated interlocks, or the physical RUN control.
For the Wahid demonstration, all sensor values, defects, motion, classifications, and communications are local simulation only.