Entelik
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The Platform · 35 modules

The full operational spine of a mid-size Indian formulator.

Production planning to calibrated equipment to released batch. Every record linked. Every signature enforced. Every change traceable.

Book a 30-min demoWalk the spine
12 steps · 6 phases · 5 logins

Walk the spine.

One real order. One real batch. End-to-end. Played across role-switched logins.

Phase 0Production planning + equipment readiness
  1. Step 0a
    Kavitha Nair — Admin
    /planning/orders

    ERP pulls SAP-PRO-2026-7842. Field mapping resolves to PO-2026-0042 (Paracetamol, 1.2M tablets, External Bharat Pharma, target 01 Jun 2026, SITE-A).

  2. Step 0b
    Mohit Verma — Supervisor
    /planning/calendar + /calibration/equipment

    Splits PO into 4 schedule entries. SE-2026-0102 on LINE-A2 picks up the CP-01 calibration-overdue blocker. Drills into eq-004 — PQ flagged Requalification Required. Reschedules SE-2026-0102 with calibration_block reason → auto-flagged change control. SE-2026-0101 on LINE-A1 clears all four checks. Confirms with e-signature.

Phase 1Recipe + batch setup
  1. Step 1
    Dr. Suresh Patel — QA Approver
    /recipes/MBR-2025-001

    Reviews and approves MBR-2025-001 for Paracetamol Tablets IP 500mg. E-signs.

  2. Step 2
    Mohit Verma — Supervisor
    /batches/new?scheduleEntryId=se-001

    Creates the batch from confirmed schedule entry SE-2026-0101. Deep-linked from the Schedule page. Materials list auto-pulls from MBR.

Phase 2Materials + incoming QC
  1. Step 3
    Anita Desai — QA Reviewer
    /materials/incoming-qc

    Clears the API and excipients. CoA verified. Out-of-tolerance flags green. Materials released for dispensing.

Phase 3Production execution
  1. Step 4
    Rajan Kumar — Operator
    /batches/B-2026-0142 · Granulation

    Executes step-by-step. Real-time data capture. Tolerance bands enforced inline.

  2. Step 5
    Rajan Kumar — Operator
    Compression step

    Hardness reading drifts out-of-tolerance. ToleranceField fires red. Deviation raised live.

  3. Step 6
    Mohit Verma — Supervisor
    /deviations/DEV-2026-0089

    Acknowledges the deviation. Routes for investigation.

Phase 4Quality + deviation
  1. Step 7
    Anita Desai — QA Reviewer
    AI Investigator

    Ishikawa diagram auto-built. 5-Why drafted. Three CAPA recommendations surface, ranked by likelihood.

  2. Step 8
    Anita Desai — QA Reviewer
    CAPA

    Selects CAPA-2026-0143. Links to deviation, batch step, equipment, operator's training record. One click each.

Phase 5Batch release
  1. Step 9
    Anita Desai — QA Reviewer
    /batch-release/B-2026-0142

    Exception-based review. Only the flagged deviation needs eyes. Everything else auto-passes.

  2. Step 10
    Dr. Suresh Patel — QA Approver
    Final release

    E-signs with GmpSignatureModal — username, password, meaning. Batch is Released.

Total elapsed time, end-to-end: hours, not days. Total paper generated: zero.

Module map

Every module. Every route.

Organised by sidebar bucket, in the order the operator and QA Head see them.

Plan

  • · Planning Overview
  • · Production Orders (list/new/detail with ERP doc + audit trail)
  • · Gantt Schedule Board
  • · Schedule Entry detail (reschedule drawer, change-control auto-flag, e-sign)
  • · Conflicts (severity/type/site filters)
  • · Roster (operator × day × shift)
  • · Plan Dashboard

Make

  • · Recipe Designer (MBR)
  • · Batch Execution (eBMR with step-level execution + live data)
  • · Shop Floor + Batch/Equipment drill-downs
  • · Materials + Dispensing + ERP reconciliation
  • · Logbooks + Templates
  • · Warehouse
  • · WIP Tracker

Quality — Events

  • · Deviations
  • · CAPA Manager
  • · Complaints

Quality — Governance

  • · Change Control
  • · Audits

Quality — Lab

  • · Incoming QC
  • · LIMS
  • · Stability
  • · Env. Monitoring
  • · Cleaning Validation

Quality — Release

  • · Batch Release (exception-based)

Quality — Assets

  • · Calibration & PM (Dashboard, Equipment ledger, 7-tab detail, IQ/OQ/PQ stepper)
  • · Work Orders with 3-stage e-sign chain
  • · Schedule, Standards library
  • · Suppliers

Regulatory

  • · Submissions (dossiers, queries, HA submissions)
  • · Drug Safety: ICSR list/detail/intake, Signals, PSUR, PSMF
  • · Clinical Trials (CTMS)

Insights

  • · Site: Enterprise Overview, Reports, Analytics, Compliance, Benchmarking
  • · Cross-Site: Deviations, CAPAs
  • · AI: Intelligence, Process Control (golden batch, SPC), AI Investigator

Docs & Training

  • · Documents
  • · Training (curricula)
  • · My Training

Platform

  • · ERP Integration (setup, field mapping, sync log)
  • · OT Integration
  • · SCADA / OT
  • · EMS Settings
  • · Sites admin
Platform primitives

What every record carries.

Five GMP primitives, enforced everywhere — not bolted on per module.

Audit trail on every record.

Two surfaces: a right-sliding sheet for any record, inline timelines on Calibration and Planning detail pages. Same data model. Never deletable. Never editable.

E-signatures that re-prompt every time.

Username + password + meaning, every signature, every time. Three-strike server-side lockout. No SSO passthrough on critical signatures. No PIN. No checkbox.

No backdating. No deletion.

Server-assigned timestamps. Records are immutable. Amendments require a reason and create a new version. The original is preserved.

Out-of-tolerance flags on every numeric field.

Red border. Warning icon. Immediate. Operator can't proceed past an OOT reading without raising a deviation.

IST display, UTC storage.

Date math always correct. Auditors see local time. Backend has the truth.

Two ways in.

Primary

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No SDR. No qualification call. You get the founder.

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Soft entry

Free 2-day on-site compliance gap assessment.

No software pitch. You get a 1-page paper-traps report. Yours to keep, even if you never buy.

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