✓Real-time Connectors: OPC-UA, MQTT, REST API, HL7 FHIR (Device Data)
✓Trend Analysis: 90-day
✓Alerts: Email, SMS, WhatsApp
✓Multi-site Aggregation
📈 Real-time Chart
metric:device_precision
unit:μm
timeframe:real-time
chart type:scatter
tolerance upper:5
tolerance lower:-5
nominal:0
update interval ms:3000
data source:OPC-UA
topic:assembly/precision/measurement
📊 KPI Card
metric:first_pass_yield
label:First Pass Yield
format:percentage
target:99.2
critical low:97
description:Devices passing QC on first attempt — ISO 13485 requires documented yield tracking
📊 KPI Card
metric:dhr_completion_rate
label:DHR Completion
format:percentage
target:100
critical low:98
description:Device History Record completion rate — FDA requires 100% DHR before release
📊 KPI Card
metric:bioburden_count
label:Bioburden (CFU)
format:integer
target:100
critical high:500
description:Colony forming units — must remain below threshold for sterile device assembly
📉 Trend Analysis
metrics:["device_precision","first_pass_yield","dhr_completion_rate"]
periods:[7,30,90]
chart type:multi_line
show control limits:true
show cppk:true
export format:["pdf","csv","xlsx"]
📋 Data Table
title:Device Traceability
columns:[{"key":"serial_number","label":"Serial #","sortable":true},{"key":"lot_id","label":"Lot ID","sortable":true},{"key":"device_type","label":"Device Type","sortable":true},{"key":"assembly_line","label":"Line","sortable":true},{"key":"operator_id","label":"Operator","sortable":true},{"key":"precision_um","label":"Precision (μm)","sortable":true,"type":"number"},{"key":"qc_result","label":"QC Result","type":"badge","badges":{"pass":"green","fail":"red","rework":"yellow"}},{"key":"timestamp","label":"Timestamp","sortable":true,"type":"datetime"}]
sort by:timestamp
sort order:desc
filters:["device_type","qc_result","assembly_line","date_range"]
pagination:25
📄 Compliance Report
standards:["ISO 13485","FDA 21 CFR Part 820","EU MDR 2017/745"]
report types:["device_history_record","traceability_matrix","ncr_summary","corrective_action"]
frequency:per_batch
auto generate:true
pdf template:med_device_compliance_report
include signature block:true
retention days:3650
🔔 Alert Engine
rules:[{"name":"Precision Out of Tolerance","metric":"device_precision","condition":"outside_range","range":[-5,5],"severity":"critical","message":"Device precision outside ±5μm tolerance — production hold required","channels":["email","sms","whatsapp"]},{"name":"DHR Incomplete","metric":"dhr_completion_rate","condition":"below","threshold":100,"severity":"critical","message":"Device History Record incomplete — device cannot be released per FDA 820","channels":["email","sms","whatsapp"]},{"name":"Bioburden Elevated","metric":"bioburden_count","condition":"above","threshold":500,"severity":"warning","message":"Bioburden CFU above 500 — cleanroom investigation required","channels":["email","whatsapp"]},{"name":"FPY Drop","metric":"first_pass_yield","condition":"below","threshold":97,"severity":"warning","message":"First Pass Yield below 97% — assembly process issue suspected","channels":["email"]}]
channels:{"email":{"enabled":true,"recipients":["quality_manager","production_manager"]},"sms":{"enabled":true,"recipients":["quality_manager"]},"whatsapp":{"enabled":true,"group":"med_device_quality"}}
🏭 Site Aggregator
max sites:3
metrics:["first_pass_yield","dhr_completion_rate","device_precision","bioburden_count"]
comparison mode:side_by_side
ranking metric:first_pass_yield
Compliance Standards
ISO 13485:2016 (QMS)FDA 21 CFR Part 820EU MDR 2017/745IEC 62304 (Software Lifecycle)
Supported Data Connectors
OPC-UA
● Connected
MQTT
● Connected
REST API
● Connected
HL7 FHIR (Device Data)
● Connected