Pharmaceutical Manufacturing
Solutions
QAS delivers MES, PLC/SCADA, ERP integration and AI analytics purpose-built for pharmaceutical manufacturing — FDA 21 CFR Part 11, GMP batch records, serialisation and end-to-end quality management, with 24/7 onsite and remote support.
What Pharma Plants Face Every Day
Pharmaceutical manufacturing operates under the strictest regulatory frameworks of any industry. A single batch record error, an audit observation or a data integrity breach can halt production, trigger recalls or result in consent decrees. We understand the stakes — and we build systems that guarantee compliance while maximising output.
What We Build for Pharma Plants
End-to-end automation, compliance and digitalisation capabilities — all delivered by a single experienced partner who understands GMP from the ground up
Pharmaceutical MES (GMP)
FDA 21 CFR Part 11 compliant MES built for pharmaceutical lines — electronic batch records, production order management, in-process controls, EBR sign-off and full audit trail from dispensing to packaging.
PLC & SCADA / DCS
GMP-compliant PLC and DCS programming for granulation, blending, filling, lyophilisation and packaging lines. SCADA/HMI with 21 CFR Part 11 electronic signatures, audit trail and access control.
ERP Integration (SAP)
Bidirectional SAP PP, MM, QM and WM integration with your pharma MES. Batch management, goods receipt, usage decisions, inventory reconciliation and production order confirmations — all automated and audit-trailed.
IIoT & Process Connectivity
Connect granulators, tablet presses, coaters, lyophilisers, filling lines and CIP/SIP systems via OPC-UA and MQTT. Real-time process parameter capture linked to batch records — every value, every timestamp.
Quality & Compliance
Electronic deviation management, CAPA workflow, change control and risk management integrated with your MES and ERP. Full ALCOA+ data integrity — attributable, legible, contemporaneous, original and accurate.
AI Analytics & Predictive
Predictive batch yield modelling, OEE dashboards, right-first-time analytics and equipment predictive maintenance. AI process optimization for critical process parameters — blend endpoint, granule PSD and dissolution prediction.
Every Function, Covered
A full catalogue of pharmaceutical-specific manufacturing functions we have designed, built and deployed in GMP production environments
Batch & Production Mgmt
Quality & Compliance
Traceability & Serialisation
Maintenance & Asset
Process & Equipment Connect
ERP & System Integration
Reporting & Analytics
Regulatory & Compliance
Support That Never Stops — Just Like Your Batches
Pharmaceutical manufacturing runs around the clock. Our support model is built to match — onsite GMP-trained engineers on your shift pattern, remote monitoring 24/7, and planned maintenance that fits your production schedule.
Ready to Transform Your Pharma Plant?
From a single line EBR implementation to a full plant GMP digitalisation programme — talk to our pharma specialists and get a tailored proposal with compliance roadmap and ROI estimates.