EIS
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EIS
EIS

AI for Life Sciences.
Built on 30 years of knowing what compliance actually takes.

Regulated industries don’t get to experiment in production. You can’t afford to get AI wrong.

EIS brings the domain expertise, regulatory fluency, and implementation capabilities to help you get it right the first time.

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Years in Life Sciences

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Implement your AI systems with confidence

In regulated industries, ‘move fast and break things’ isn’t an option. Your AI initiatives need to be compliant from day one, validated to regulatory standards, and defensible under audit. 

EIS has been navigating this exact tension for three decades. We bring the rigor to every AI engagement so you can innovate with confidence.

End-to-end AI services for regulated manufacturing

  • AI Strategy & Roadmap

    Identify high-value AI use cases for your manufacturing, quality, and operations. Prioritize by ROI, feasibility, and regulatory risk. Build a phased roadmap aligned to your digital maturity.

  • Architecture & Data Foundation

    Design the data pipelines, integration layers, and infrastructure your AI needs. Leverage existing Historian, MES, and DCS data. Ensure data integrity and ALCOA+ compliance from the ground up.

  • Implementation & Integration

    Build, train, and deploy AI models within your GxP environment. Integrate with existing shop floor systems (MES, SCADA, DCS, Historian). Platform-agnostic approach: we select the right tool for the job.

  • Validation & Compliance

    Validate AI systems per GAMP 5, CSA, and 21 CFR Part 11. Document intended use, risk assessment, and performance qualification. Ensure audit-readiness from first deployment.

  • Generative AI Enablement

    Deploy GenAI for document drafting, deviation analysis, SOP generation, and knowledge management. Establish guardrails, usage policies, and compliance frameworks for LLM adoption in regulated environments.

  • Governance & Change Management

    Build the organizational structures, policies, and training programs to sustain AI at scale. Define model monitoring, retraining triggers, and human-in-the-loop protocols. Drive adoption across your workforce.

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Why EIS...

Generic firms can build models, but they don’t know what 21 CFR Part 11 means for your data. They haven’t navigated GAMP 5 validation, nor have they stood in front of an FDA auditor. 

We have.

EIS understands both the domain and the technology, so you can implement AI with confidence, not stress.

  • Regulatory Fluency

    FDA, EMA, GAMP 5, 21 CFR Part 11, Annex 11, CSV/CSA built into every engagement

  • Domain Depth

    MES, DCS, Historian, batch records, shop floor ops. We speak your language.

  • Fast Implementation

    LLMs, predictive models, computer vision, NLP - applied to real manufacturing problems

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AI is only as good as the Data behind it

Most AI consultancies start at the model layer. They assume your data is clean, structured, and ready. It almost never is. EIS starts where the data is born: at the process level, on the shop floor, inside the systems that generate it every day.

We’ve spent 30 years designing the MES, DCS, and Historian implementations that create this data. We know what good manufacturing data looks like because we’ve been building the systems that produce it.

EIS Expertise

Data Collection

Process design, system config, data structures that capture the right data at the source

EIS Expertise

Data Integrity

ALCOA+ compliance, audit trails, contextualized and trustworthy data pipelines

EIS Expertise

AI Output

Models trained on real, structured, compliant data produce actionable results.

AI Use Cases across the manufacturing lifecycle

  • Predictive maintenance
  • Process optimization
  • Deviation & CAPA analysis
  • AI-assisted review-by-exception
  • Intelligent document management
  • AI-assisted reports/dashboards
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Operational intelligence

To get started, follow these 3 Steps to Success

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Book a Free Consultation at a time that suits you.

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 Speak to our professional team who will happily discuss and assess your project requirements.

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Agree on a customized strategy and plan to address your project requirements.

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