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Industry Solutions

Pharmaceutical Industry Connectivity Solutions

Purpose-built connectivity for drug manufacturing, biologics production, and clinical operations—ensuring FDA compliance, data integrity, and validated system performance.

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Connectivity Challenges in Pharmaceutical Manufacturing

Pharmaceutical manufacturers face stringent data integrity and validation requirements that demand specialized connectivity solutions.

FDA 21 CFR Part 11 Compliance

Electronic records and signatures require validated systems with audit trails, data integrity controls, and secure access management for all manufacturing data.

Data Integrity (ALCOA+)

Attributable, Legible, Contemporaneous, Original, and Accurate data principles plus Complete, Consistent, Enduring, and Available requirements across all systems.

System Validation (CSV)

Computer System Validation requires IQ/OQ/PQ documentation, change control procedures, and ongoing validation maintenance for all GxP systems.

Batch Manufacturing Control

ISA-88 compliant batch systems for API synthesis, fermentation, purification, and formulation must integrate with DCS, MES, and LIMS systems.

Environmental Monitoring

Cleanroom conditions, temperature mapping, humidity control, and particle counts require continuous monitoring with validated data collection systems.

Serialization & Track-Trace

Drug Supply Chain Security Act (DSCSA) compliance demands serialization at unit, case, and pallet levels with complete chain of custody tracking.

Common Devices in Pharmaceutical Manufacturing

Pharmaceutical facilities use specialized DCS, batch systems, and process equipment. Our solutions connect them all seamlessly.

Emerson

DeltaV DCS, Batch Management, Syncade MES

Rockwell Automation

ControlLogix PLCs, FactoryTalk Batch, PharmaSuite

Siemens

S7 PLCs, PCS 7 DCS, SIMATIC Batch

Honeywell

Experion PKS, PlantScape Batch, TDC 3000

Yokogawa

CENTUM VP DCS, Exaquantum PIMS, Batch Control

GE Digital

iFIX SCADA, Proficy Historian, MES Solutions

Plus extensive support for Sartorius bioprocess systems, Cytiva chromatography equipment, Mettler Toledo scales, Endress+Hauser instrumentation, and specialized pharmaceutical manufacturing equipment.

Essential Drivers for Pharmaceutical

TOP Server provides 140+ industrial drivers, including all critical DCS, batch controller, and instrumentation protocols for pharmaceutical manufacturing.

Allen-Bradley ControlLogix/CompactLogix

Rockwell

Siemens S7-300/400/1200/1500

Siemens

Modbus TCP/IP & RTU

Universal

Emerson DeltaV

DCS

Honeywell Experion PKS

DCS

Yokogawa CENTUM VP

DCS

Schneider Electric Modicon

Schneider

Mitsubishi PLCs

Mitsubishi

ABB System 800xA

DCS

EtherNet/IP

Industrial Ethernet

Profinet IO

Industrial Ethernet

Foundation Fieldbus

Fieldbus

All drivers included in TOP Server Full Edition—no per-driver licensing fees.

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Why the Right Connectivity Solution Matters

TOP Server

The industry-standard OPC Server designed for validated pharmaceutical environments:

21 CFR Part 11 Ready: Electronic signatures, audit trails, and access controls built for FDA compliance
Validation Support: IQ/OQ/PQ documentation packages and change control procedures included
Batch System Integration: ISA-88 compliant connectivity to DeltaV, FactoryTalk Batch, and PCS 7
Data Integrity (ALCOA+): Timestamped, immutable records with complete chain of custody

Cogent DataHub

Enable multi-site operations and advanced analytics for pharmaceutical:

Multi-Site Quality: Aggregate manufacturing data from global cGMP facilities into centralized dashboards
Batch Genealogy:: Complete traceability from raw materials through finished product distribution
Cloud Integration: Secure, validated pipelines to AWS, Azure for predictive analytics and AI/ML
MES/ERP/LIMS Integration: Bridge manufacturing data to SAP, Oracle, or specialized pharma systems

Together, They Transform Pharmaceutical Operations

TOP Server connects your DCS, batch systems, and process equipment with validated, audit-ready data collection. Cogent DataHub aggregates multi-site data and enables advanced analytics. The result: FDA compliance assurance, accelerated batch release, complete data integrity, and data-driven continuous improvement across your entire pharmaceutical enterprise.

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Mission-Critical Support for Validated Systems

Pharmaceutical manufacturing requires validated systems with comprehensive support to maintain compliance and operational continuity.

Validated System Support

24/7/365 phone support with 1-hour response for validated systems
IQ/OQ/PQ documentation packages and validation assistanc
Change control support aligned with FDA and EMA requirements
Dedicated technical account manager with pharma expertise

GxP & Compliance Expertise

Our support engineers understand cGMP requirements, 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+), and the critical nature of pharmaceutical validation.

Continuous Compliance

Proactive system health monitoring, periodic revalidation support, audit trail reviews, and compliance assessments ensure your systems remain in validated state.

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Pharmaceutical Customer Success Stories

"FDA 21 CFR Part 11 compliance and data integrity were paramount for our biologics manufacturing. TOP Server's electronic signature capabilities and comprehensive audit trails enabled us to implement a fully validated system across our fermentation, purification, and fill-finish operations. We achieved FDA pre-approval inspection (PAI) approval on first submission with zero CAPA related to our data systems."

VP of Quality & Regulatory Affairs

Global Pharmaceutical Manufacturer

Results: Zero FDA data integrity findings, 100% batch record traceability, PAI approval

"With 12 cGMP suites supporting multiple clients and products, we needed flexible connectivity that could handle frequent recipe changes while maintaining validation status. Cogent DataHub's multi-site aggregation now gives us real-time visibility across all manufacturing operations, reducing batch release time by 35% and enabling predictive maintenance that cut unplanned downtime by 40%."

Director of Operations

Contract Manufacturing Organization

Results: 35% faster batch release, 40% less downtime, 12 suites connected

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Ready to Transform Your Pharmaceutical Operations?

Let's discuss how our proven, validated connectivity solutions can ensure FDA compliance, accelerate batch release, and enable digital transformation across your pharmaceutical enterprise.

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