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MES Integration, Installation, and Configuration

MES Integration, Installation, and Configuration

Two people standing at a desk, looking at two screens with compliance data.

Connecting the Digital Thread in Life Sciences Manufacturing

Installing, integrating, and/or configuring an MES (Manufacturing Execution System) platform are key steps in the digital manufacturing journey for manufacturers in the life sciences sector. MES platforms have the potential to modernize and enhance existing workflows and processes, while streamlining compliance, eliminating bottlenecks, and enhancing oversight.

 MES integration in the pharmaceutical, biopharmaceutical, and medical device industries presents unique challenges. Existing IT and operational technology (OT) architectures are complex, while data integrity, traceability, and regulatory compliance are essential components.

 NNIT brings deep cross-domain expertise spanning both IT and OT sides of the MES integration equation. We also have extensive experience in the life sciences sector, plus our consultants have comprehensive knowledge of the main MES platforms used in the life sciences sector.

 We also work across the full technology stack, from PLCs and SCADA on the production floor to ERP and other enterprise-level systems. NNIT's MES integration, installation, and configuration specialists can help achieve your digital manufacturing project, production operations, and wider business goals.

The Unique Complexities of MES Integration in Life Sciences

The complexities of MES integration projects in the life sciences sector are multi-layered and varied. Understanding those complexities is essential to ensuring MES integrations are successful and can be built on in the future as your operations develop and technology stack matures.

 Regulated Manufacturing

MES platforms have to do more than manage production in regulated environments such as those in the life sciences sector. In the life sciences sector, MES platforms have to manage production, but they are also often a critical part of the quality management system. Therefore, there are essential patient safety, product quality, and compliance factors that must be risk-assessed and mitigated.

 Diverse IT/OT Architectures

It is common for IT/OT architectures in life sciences manufacturing facilities to be highly diverse and complex, often across multiple sites and regulatory jurisdictions. IT/OT architectures evolve over time, so they often include legacy equipment, software, PLCs, and SCADA systems. These systems all operate on production lines that are fully validated, adding to the compliance complexity.

Upstream, there are often modern ERP (Enterprise Resource Planning), PLM (Product Lifecycle Management), LIMS (Laboratory Information Management Systems), and QMS (Quality Management Systems) platforms performing essential functions, as well as historians and other IT systems. All of these platforms, systems, and processes need to be fully considered during an MES integration.

 Unique Pain Points

There are unique pain points that need to be addressed during MES integration, installation, and configuration projects in the life sciences sector. Examples include:

  •  Maintaining data integrity – an MES platform helps strengthen the digital thread in life sciences manufacturing organizations, with data as the backbone. Not all data is equal, however, so it is essential that data integrity is maintained through established principles such as ALCOA+.

  • Managing change control – production lines and processes in life sciences manufacturing facilities must remain in a validated state. Robust change control processes are, therefore, essential for validated systems.

  • Point-to-point integrations – it can be straightforward to develop a custom point-to-point integration to connect a node in the OT architecture (a machine, system, or platform) to the MES platform. However, point-to-point connections quickly scale in number in complex life sciences manufacturing environments, significantly increasing the engineering and validation challenge during setup as well as in the future during upgrades and re-validation.

The Cost of Failure

The stakes are high in the life sciences sector when implementing major technology upgrades, such as an MES system integration. Situations such as failed batch records, regulatory findings, production downtime, and delayed product releases demonstrate that the cost of failure is measured not just commercially, but also in terms of patient safety.

Understanding this is essential for success, as is a strong track record of MES integration projects in pharmaceutical, biopharmaceutical, and medical device manufacturing facilities.

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MES Integration Architecture

In a life sciences manufacturing facility, an MES platform sits in the middle part of the technology stack, helping to connect downstream processes on the production floor to upstream enterprise processes and systems. NNIT's expertise covers all levels of the functional hierarchy in the manufacturing technology stack, from PLCs and SCADA systems at Levels 1 and 2 to MES and LIMS platforms at Level 3 to ERP and other enterprise systems at Level 4.

Our consultants utilize global standards, including ISA-88 (for the design and management of batch control systems) and ISA-95 (for the design of the interface between production and business systems) when planning, developing, and implementing MES integration projects.

Downstream

This involves connecting the MES platform to PLCs, SCADA, DCS (Distributed Control Systems), historians, inline process analyzers, and other manufacturing process and control systems. It includes ensuring integrations comply with the electronic record and audit trail requirements of the FDA's 21 CFR Part 11 and Annex 11 in the EU. It is also essential to utilize industrial communication and data transfer protocols that are suitable for complex, regulated manufacturing environments, such as OPC-UA and MQTT.

Upstream

Upstream integration involves connecting the MES platform to ERP systems from providers such as SAP and Oracle, as well as other Level 3 and Level 4 systems in the ISA-95 technology stack – LIMS, PLM, QMS, etc. The focus is to ensure optimized management and oversight of operational processes, including GxP-critical processes (production order management, batch records, material traceability, release workflows, etc).

Critical issues that NNIT consultants address when developing MES integration architecture include:

  •  Bidirectional data integrity – ensuring data points are traceable and all changes are fully recorded.

  • Managing validated system lifecycles – ensuring formal change control processes are established for future updates and upgrades of the MES platform and related technologies

MES Integration Technology Expertise

 NNIT's MES integration technology expertise includes:

  • Leading MES platforms, including PAS-X, POMS, AVEVA MES, Ignition, GE Digital, Rockwell Automation, Siemens, and Apprentice.io.

  • OT communication protocols such as MQTT and OPC-UA. MQTT (Message Queuing Telemetry Transport) is a lightweight publish and subscribe communication protocol designed for machine-to-machine communication. OPC Unified Architecture (UA) is a secure, platform-independent open communication standard from the OPC (Open Platform Communications) Foundation.

  • Industrial data platforms such as Ignition and Inmation that bridge MES platforms with OT systems downstream (PLCs, SCADA, historians, etc) and IT systems upstream (ERP, LIMS, etc).

  • Configuring and validating MES ERP integrations (SAP, Oracle, etc), as well as connections to LIMS (LabVantage, LabWare, etc) platforms using the above technologies, solution architectures, and communication protocols.

  • OT platforms, technologies, and edge devices, including SCADA, PLCs, historians (AVEVA PI, Canary, etc), and sensors.

 In summary, our MES integration expertise covers the full ISA-95 technology stack, from production line process and control systems to laboratory and quality systems to IT and enterprise systems.

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MES Integration Services for Life Sciences Manufacturers

NNIT offers a unique depth of expertise in MES integration, installation, and configuration projects. Our engineers, consultants, and systems architects work across the full ISA-95 manufacturing technology stack, covering the full range of IT and OT systems, from legacy platforms to advanced solutions.

 We also have decades of experience delivering digital manufacturing solutions in the pharmaceutical, medical device, and biopharmaceutical industries. Validation and regulatory compliance are core components of our MES implementation approach. That implementation approach includes:

 Our consultants, engineers, and systems architects have deep knowledge of MES and related platforms, but we take a vendor-agnostic approach to ensure an optimized, technically robust, fully compliant, and future-ready MES integration that meets your specific requirements.

FAQs

  • What is MES integration?

    MES integration is the process of connecting a Manufacturing Execution System (MES) to other software and hardware systems in a manufacturing environment. Downstream, this includes PLCs, SCADA, historians, sensors, and similar technologies. Upstream, it includes ERP, LIMS, PLM, and other IT/enterprise systems.

    In life sciences, effective integration is especially important as an MES platform is not just an operational tool, as it is also part of the quality system. Every interface it has with another system is a potential point of data integrity risk. As a result, a well-designed and fully validated integration is critical for both regulatory compliance and operational performance.

  • What is the difference between upstream and downstream MES integration?

    Downstream integration connects the MES to production (shop floor) systems. This includes MES integration with SCADA, PLCs, DCS, historians, and edge devices. Downstream MES integration enables the real-time handling of process data, equipment status, and control signals.

    Upstream integration connects the MES platform to enterprise systems. This includes ERP, LIMS, PLM, and quality management systems. Upstream MES integration facilitates efficient and data-driven handling of production orders, batch records, material traceability, and reporting.

     Both MES integration directions need to work reliably and, in GxP-critical environments, both need to be validated.

  • What is a Unified Namespace (UNS)?

    A Unified Namespace is an architectural approach to data transfer and communication where all systems in a manufacturing environment publish and consume data through a single, centralized, and contextualized data model. It's a more engineering-efficient, scalable, and legacy equipment-compatible solution compared to the main alternative, where all connections are point-to-point.

     Instead of point-to-point connections, every system (MES, ERP, SCADA, historian, etc) publishes and subscribes to data within a hub-and-spoke model.

     In life sciences, a UNS architecture approach is increasingly relevant because it reduces integration complexity, makes data auditable, and significantly reduces the number of individually validated integrations that need to be maintained.

  • Does NNIT implement MES integration or just advise on it?

    NNIT delivers end-to-end MES integration, configuration, and installation solutions to global life sciences manufacturers in Europe, the USA, and around the world. Our capabilities cover all project stages, from existing process and technology assessments to architecture design and interface specification to development, configuration, validation, implementation, and go-live support.

     

    Our teams include both OT/IT integration consultants, engineers, system architects, and validation specialists. This means the people who design and build the MES integration and the people who validate it work together from the start.

  • Can NNIT work with our existing MES, or do we need to change platforms?

    NNIT is vendor-agnostic, so we can work with the MES platform already in use in your environment. Our integration expertise spans the leading life sciences MES platforms as well as the surrounding technology stack (ERP, LIMS, historians, SCADA, edge devices, etc).

     

    NNIT's approach is to design integration solutions around your existing landscape rather than imposing a preferred platform.

  • How does NNIT handle MES integration validation in life sciences manufacturing environments?

     Validation is built into our delivery methodology from the start. We apply a GAMP5-aligned approach that includes GxP impact assessments, risk-based validation planning, and full IQ/OQ/PQ documentation. Importantly, the engineers who design and build the MES integration are also involved in the validation process. As a result, the documentation we produce reflects what was actually built, not a retrospective interpretation of it.

  • Can NNIT support MES integration across multiple sites or regulatory jurisdictions?

    Yes. NNIT has experience delivering MES integration solutions for global life sciences manufacturers that operate across multiple sites and regulatory environments. This includes FDA, EMA, and other regulatory jurisdictions. We support both greenfield implementations and brownfield environments where legacy systems and existing validated infrastructure need to be preserved.

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