From production plan to released batch.
On one platform.
Entelik replaces paper batch records, deviation logs, equipment binders, calibration spreadsheets, and the QA approval pile-up with one connected, 21 CFR Part 11–compliant system. Built for mid-size Indian pharma.
No SDR. No qualification call. You get the founder.
35 modules · 6-role hierarchy · 21 CFR Part 11 · GAMP 5 · Built in India, for India and SEA
What's actually broken in your plant.
Not "digital transformation." Four specific operational failures that show up in every audit, every release meeting, every Monday standup.
Your batch records take 8-12 days to release.
QA reviews every line of every paper record. By the time you spot a deviation, the operator has gone home, the equipment is in cleaning, and the memory is gone. Working capital sits idle. The CFO notices.
Your deviations stall because nothing is linked.
The deviation cites a step. The step references a material. The material has a CoA. The CoA references a supplier. None of it is one click away. So the investigation drags. So the CAPA is late. So the auditor flags it.
Your audit prep takes 3 weeks of a senior QA's life.
Two audits a year, six weeks of senior QA time pulled out of their actual job. The week of the audit, three people print binders. By 8 PM the night before, someone is photocopying the calibration log from 2023.
Your schedule, equipment, and batch live in three different places.
The production schedule is in Excel. Calibration is in a binder. The MES knows about neither. So you schedule a batch on a line whose CP-01 went out of calibration on Monday — and you find out on Wednesday, mid-granulation.
One example. Cross-module. Real.
A calibration goes overdue. Watch what happens before anyone schedules the next batch.
CP-01 thermocouple
Calibration overdue flag fires on the equipment ledger. PQ status flips to Requalification Required.
SE-2026-0102 At Risk
Production planning surfaces the schedule entry (Paracetamol, Line A2) as blocked with a calibration-overdue reason.
WO-CAL-2026-0017
Work order raised. Technician Mohit Verma performs the cal, signs with GmpSignatureModal.
Two QA signatures
Anita Desai (QA Reviewer) verifies. Suresh Patel (QA Approver) releases the equipment — second signature on the chain.
Batch can start
SE-2026-0102 clears to Confirmed. Plant Head and QA Head see the same status change in the same minute.
Most pharma SaaS treats production planning, calibration, and batch records as three separate purchases. We don't. The wiring between them is the product.
35 modules. One login. Six roles.
The full operational spine of an Indian formulator — manufacturing, quality, planning, regulatory, safety, calibration, and the platform underneath it all.
Manufacturing
- · Recipe Designer (MBR)
- · Batch Execution (eBMR)
- · Logbooks + Shop Floor
- · Materials + Dispensing
- · WIP Tracker + Warehouse
Quality
- · Deviations + AI Investigator
- · CAPA + Change Control
- · Batch Release (exception-based)
- · Cleaning Validation + LIMS
- · Audits + Complaints + Stability
Calibration & PM
- · Equipment ledger
- · Work orders, 3-stage e-sign
- · IQ/OQ/PQ qualification
- · PM scheduling + Standards
- · Breakdown tracking
Production Planning
- · Production Orders + ERP intake
- · Gantt schedule board
- · Operator Roster
- · Cross-module Conflicts engine
- · Reschedule + change-control
Regulatory & Safety
- · Submissions, dossiers, HA queries
- · Pharmacovigilance ICSR intake
- · Signals, PSUR, PSMF
- · Clinical Trials (CTMS)
- · Document control + training
Platform & Advanced
- · ERP + OT/SCADA integration
- · Intelligence (batch risk, yield)
- · Process Control + SPC
- · Multi-site enterprise view
- · Role-based access, 6-role
On a typical 500-employee site.
~100 batches/month · ₹20L avg batch value · 9-day avg release. Pick what you trust. The rest is upside.
| Lever | Annual impact |
|---|---|
| Working capital freed by faster release | ₹16-22 L |
| Avoided batch rejections | ₹30 L – 1 cr |
| Audit prep saved | ₹6-8 L |
| OEE lift from coordination | ₹40 L – 1.5 cr |
| Inspection-failure insurance | Hard to price |
| Total realistic year-one value | ₹50 L – ₹2 cr |
Annual cost: ₹18-25 L/yr per site, all-in. Payback typically under three months on working capital alone.
Run the numbers on your plantPilot in 30 days. Pay back in 90. Walk away clean.
A guided pilot designed to prove stability without disrupting current production lines.
Site audit
Free 2-day on-site compliance gap assessment. You get a 1-page paper-traps report. Yours to keep, whether you buy or not.
Digitization
Light deployment. One recipe. One line. Real operators. IQ/OQ validation protocols configured.
Parallel run
Real batches in parallel with paper. Paper stays the source of truth. Three batches to verify data integrity.
Go-live or walk
Pay-to-continue gate. If release time hasn't dropped 40%+, money back. Walk away clean.
Pilot fee ₹3-5L, refundable. Risk to you if it doesn't work: ₹0.
See full pilot termsFor the QA Head whose job is on the line. The Plant Head whose OEE is on the line. The Promoter writing the cheque.
The QA Head
You're the one who answers to the inspector. Entelik is 21 CFR Part 11 by default — every signature, every audit trail, every change reason. No checkbox shortcuts. No SSO passthrough on critical signatures. Three-strike lockout. Built so an FDA inspector walking in unannounced is a normal Tuesday, not a 14-hour fire drill.
The Plant Head
You're the one whose batches need to ship. Entelik connects the schedule, the equipment, and the batch — so you stop discovering calibration problems mid-granulation. Faster release. Fewer rejections. OEE up 3-5%. The math holds.
The Promoter / MD
₹18-25L/yr per site. Pilot is money-back. First-year ROI is 3-10x. No multi-year lock-in. No "call for pricing" games. The price is on the website.
Two ways in.
Book a 30-min demo with the founder.
No SDR. No qualification call first. You get me. We'll walk the platform end-to-end. If it's not a fit, I'll tell you in the first ten minutes.
Or book a free 2-day on-site compliance gap assessment.
We come to your plant. Two days. No software pitch. You get a 1-page paper-traps report at the end. Yours to keep, even if you never buy.
Or email hello@entelik.com.