GMP-Validated · 21 CFR Part 11 · EU Annex 11
Pharmaceutical Manufacturing
Intelligence Platform
AriLinc brings AI/ML to pharma batch manufacturing — predicting deviations, optimising yield, automating compliance records, and reducing OEE losses. Validated, audit-ready, and deployable in weeks.
Rs 32–56 Cr
Annual value · per plant
3–5%
API yield uplift
45%
Deviation reduction
100%
21 CFR auto-compliance
Active Batch Status
Plant Efficiency — 7-Day Trend
LIVE
Live Alert Feed
REAL-TIME
Module Status
Batch Yield Prediction — API Manufacturing
LIVE · XGBoost + LSTM
Critical Process Parameters — Reactor R-04
IN-PROCESS
Golden Batch Score — Active Batches
AI SCORED
Batch Deviation Prediction
PREDICTIVE
Recent Batch Records — Auto-Generated
21 CFR READY
OOS / OOT Trend — Last 90 Days
TRENDING
CAPA Status Dashboard
LIVE
Open Deviations by Category
Deviation Log — AI Root Cause Tagged
AI TAGGED
Active CIP / SIP Circuits — Manufacturing Block A
Conductivity Profile — Vessel V-201
LIVE
Chemical Saving vs Manual CIP
AI CONTROLLED
CIP Validation Records — Cleaning Efficacy
21 CFR §211.67
SIP Steam Profile — Autoclave A-3
IN-PROCESS
OEE — Critical Equipment (Last 30 Days)
MEASURED
Predictive Maintenance — Fault Probability
AI FORECAST
Downtime Analysis by Loss Category
Maintenance Work Orders — AI Prioritised
SCHEDULED
Electronic Batch Records — Part 11 Audit Trail
21 CFR PART 11
Audit Trail — System Access & Changes
PART 11 §11.10(e)
Compliance Score Trend
IMPROVING
Regulatory Readiness Checklist
Business Value · ROI Analysis
Six use cases. One platform.
Measurable from Day 30.
Indicative for a mid-size pharma plant · 5–8 API product campaigns/year · Full-scale numbers proportionally higher
Monthly Value Ramp — Year 1 (Rs Lakhs)
PROJECTED
5-Year TCO — Status Quo vs AriLinc
Proposed 60-Day Pilot — 1 Manufacturing Plant
Read-only connection to existing DCS / SCADA historian and LIMS. No process changes. Day 30 report shows measured batch yield delta, deviation count delta, and OEE improvement vs baseline.
Scope: Batch Intelligence + Quality + OEE
Data: Read-only historian + LIMS
Report: Day 30 ROI vs baseline
GxP: Validation plan included
Rs 24L
Total pilot investment