Control & Compliance for Pharmaceutical Manufacturing Systems

Securing the Systems Behind Life-Saving Production

Pharmaceutical manufacturing relies on precise, tightly controlled processes any deviation can compromise product quality, regulatory approval, or patient safety. With the rise of digital batch management, automated mixing and filling lines, smart sensors, and remote vendor access, the modern pharma plant has become deeply interconnected and increasingly exposed.

Process equipment, cleanroom systems, and environmental monitoring devices must be protected, tracked, and validated with complete accuracy. OTNexus helps pharmaceutical manufacturers safeguard production environments, enforce compliance, and maintain documented governance across every stage of the manufacturing lifecycle.

Challenges in Pharmaceutical Operations

Stringent Compliance Demands

Regulatory bodies require verifiable controls, traceability, and documented governance across all production environments.

Complex Manufacturing Equipment

Blending systems, bioreactors, and sterilization units require precise configuration oversight.

Critical Environmental Dependencies

Temperature, pressure, and airflow systems are directly tied to product integrity and must remain secure and auditable.

Vendor & Maintenance Access

Meeting standards like IEC 62443, NIST CSF, and Responsible Care cybersecurity guidelines demand structured governance and documentation.

How OTNexus Strengthens Pharmaceutical Manufacturing

Complete Oversight of Production & Facility Assets

Document and track critical OT assets, bioreactors, cleanroom systems, process controllers, utility equipment with full lifecycle visibility, configuration history, and ownership.

Governance Aligned with Regulatory Requirements

Implement policy-driven workflows and documentation that support compliance with standards such as GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and IEC 62443.

Controlled Access to High-Integrity Systems

Centralize identity and permission management to ensure only authorized operators, engineers, and OEM vendors can access sensitive production equipment and environmental systems.

Audit-Ready Compliance & Traceability

Automate evidence collection, control mapping, and documentation needed for audits, inspections, and validation activities reducing manual effort and ensuring accuracy.

Why Pharmaceutical Leaders Choose OTNexus

Built for Regulated Environments

Designed to support OT operations where quality, traceability, and compliance are inseparable.

Supports Global Regulatory Frameworks

Enhances readiness for audits by FDA, EMA, and regional regulatory authorities.

Integrates with Manufacturing & Facility Systems

Works seamlessly with SCADA, EMS, process automation platforms, and OEM equipment.

Scalable for Multi-Site Production

Adapts easily across R&D labs, formulation sites, packaging plants, and large-scale manufacturing facilities.

Strengthen the integrity of your pharmaceutical production systems.

Elevate your operations with structured governance, precise oversight, and complete traceability through OTNexus.

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