How does automation modernisation support GMP compliance?

Modern PLC and SCADA systems provide structured audit trails, improved traceability, and documentation aligned to GMP validation standards, reducing compliance risk.

Why are legacy PLC systems a risk in pharmaceutical manufacturing?

Legacy systems often lack proper audit trail functionality, structured documentation, and validation-ready architecture, increasing audit exposure and downtime risk.

How was validation considered during the upgrade?

The project began with a risk assessment aligned to validation requirements, ensuring documentation, software structure, and implementation supported regulatory expectations.

What operational improvements were delivered?

The facility achieved reduced downtime, faster fault diagnostics, improved audit readiness, and clearer system visibility.

What was the goal of this pharmaceutical automation project?

The project focused on improving system reliability, automation visibility, compliance readiness and long-term maintainability within a pharmaceutical manufacturing environment.

Why are pharmaceutical automation upgrades more complex?

Pharmaceutical automation upgrades must consider validation requirements, controlled change processes, documentation standards and regulatory compliance alongside technical improvements.

What systems were modernised during the project?

The project involved automation improvements including PLC modernisation, SCADA visibility enhancements and structured control system upgrades.

What were the benefits of the upgrade?

The upgrade improved operational reliability, visibility, compliance support, fault diagnostics and long-term supportability of the automation environment.

Pharmaceutical Automation Case Study

Pharma Automation case study being implemented.

Modernising Control Systems in a GMP-Regulated Facility

Stratos Control Systems delivered a structured PLC and SCADA modernisation project for a GMP-regulated pharmaceutical manufacturer to improve audit readiness, reduce unplanned downtime, and accelerate fault diagnostics. The upgrade strengthened validation documentation, improved traceability, replaced obsolete systems and provided a more reliable, supportable automation platform for ongoing production.

01

The Problem

The facility operated legacy PLC systems with limited audit trail capability and inconsistent documentation, increasing pressure around validation and compliance.

These constraints created operational and regulatory risk, including avoidable batch interruptions, increased exposure during audits, and extended validation timelines.

02

Scope of Work

Phase 1 – Audit & Risk Review

Stratos completed a full automation audit and risk assessment aligned with validation requirements.

This included:

Review of existing PLC, SCADA, and HMI architecture
Identification of compliance and audit trail gaps
Documentation review against GMP expectations
Risk assessment to support validation planning
Definition of modernisation scope and sequencing

Phase 2 – Upgrade Strategy

Pharmaceutical PLC and SCADA modernisation project

A structured migration and validation-conscious upgrade plan was developed to improve reliability and traceability without introducing unnecessary production risk.

The strategy included:

PLC migration plan and structured software approach
SCADA upgrade to improve audit trail and visibility
Documentation framework aligned to GMP processes
Phased implementation approach to reduce disruption

Phase 3 – Implementation

Stratos delivered the upgrade in a controlled, staged manner with clear technical documentation to support maintenance, validation, and long-term support.

Implementation included:

PLC upgrades and structured code standards
SCADA improvements with enhanced audit trail capability
Structured HMI design approach
Full EPLAN documentation pack aligned to site standards

Validated pharmaceutical automation control system

03

Pharmaceutical manufacturing automation upgrade

Platforms Used

The project utilised modern automation technologies, including:

Siemens S7 PLC
WinCC SCADA
Structured HMI design
Full EPLAN documentation

04

Outcomes & Metrics

The modernisation delivered measurable operational and compliance improvements.

Key outcomes included:

40% reduction in unplanned downtime
Improved audit readiness and traceability
Faster fault diagnostics and clearer operational visibility
Structured, validation-ready documentation aligned to GMP processes

SCADA visibility and compliance monitoring system

Testimonial

“Stratos delivered a technically robust solution while maintaining our regulatory standards. The clarity of documentation and phased implementation reduced risk significantly.”

Operations Director

Frequently Asked Questions

Strengthen GMP Automation Confidence

Modernise pharmaceutical control systems with Stratos Control Systems to improve traceability, reduce downtime, and deliver validation-conscious upgrades that stand up to audit scrutiny.

Speak to an Automation Specialist