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USA · India joint venture

Food, Dairy & Life Sciences

Pharmaceutical

Validated automation with documentation that passes audit.

Overview

What we do here

In pharma the system is not delivered until the paperwork is. We design PLC and SCADA control with 21 CFR Part 11 and qualification in mind, and hand over DQ/IQ/OQ documentation alongside the automation.

What this floor demands

  • Electronic batch records and audit trails not meeting 21 CFR Part 11
  • Change control gaps on any modification to a validated control system
  • Batch and recipe management spread across manual and automated steps
  • Alarm and event data not traceable back to a specific batch

Scope

What we deliver here

Each item below is a package we build, install and support in-house — not a subcontracted line on a quote.

01

PLC/SCADA control with 21 CFR Part 11 compliant electronic batch records

02

Recipe management and batch control to ISA-88 structure

03

Validation support: DQ, IQ, OQ protocols and as-built documentation

04

Change-control procedures for validated automation systems

05

Alarm, audit-trail and event integration tied to batch identity

Standards we work toWHO GMPSchedule M21 CFR Part 11ISA-88

Proof points

Comparable work we have delivered

CIP and batch automation with traceable records

Batch & recipe control

CIP and batch automation with traceable records

Scope: PLC-based CIP skid automation, recipe management SCADA and MES data integration.

Result: Verified cycle completion and audit-ready batch records, no manual logbook.

Let's build

Running a pharmaceutical operation?

Send a scope, a drawing or just a problem statement. An engineer who knows this floor responds within one working day.