Business Areas

Manufacturing Operations

Increase Productivity through Digitalization

Achieve operational excellence in production and supply chain, increasing digital maturity by enabling seamless data integration

As a Life Science company, you constantly face business process improvements, as well as updates in technology and regulations. Managing these changes, it can be difficult to find the balance between risk and efficiency that allows you to achieve business objectives and maintain compliance.

Implementing digital technologies and digitalization projects in the manufacturing operations space is a common challenge across many companies.

The regulated nature of the life science industry, combined with the diversity and complexity of data sources on the shop floor level, makes it difficult to find the right system architecture to balance risk and business opportunities.

Our team of experts combines deep industry knowledge with proven digital implementation strategies. We will guide you every step of the way, from defining a data-driven roadmap to ensuring smooth system integration and ongoing compliance.

From strategy to operations and data insights, we empower you to:

  • Clearly define your digital roadmap aligned with industry best practices like ISPE Pharma 4.0.
  • Implement GxP validated systems across Technical Operations with faster, lower-risk deployments.
  • Ensure compliant and optimized operations, even with cloud updates and forced releases.
  • Leverage data-driven insights to optimize processes, improve quality, and accelerate innovation
Talk to an expert
Hernan Vilas
SVP, Head of Global Manufacturing Operations


Our team assists you in defining your production & supply chain digitalization strategy, ensuring sustainable improvement for your business while meeting compliance requirements.

Strategy services can include individual services or an industry expert advising on:

  • Definition of your digitalization strategy, including a digital maturity assessment based on the BioPhorum DPMM model.
  • Creation of a digital reference architecture, based on ISA-95 industry model.
  • Definition of a strategic technology roadmap to achieve the desired level of digital maturity, in line with your business goals and objectives.
  • Selection of manufacturing IT/OT systems, including business case and ROI calculation.
  • And more

IT/OT System Implementation

Epista provides expertise to ensure you implement GxP compliant systems across Manufacturing Operations.

IT/OT System Implementation can include:

  • Project preparation: Define a clear scope, focused on business outcomes together with a robust validation strategy for smooth implementation.
  • GxP validation services: Ensure compliance with CSV/CSA standards.
  • Faster deployments: Implement MES, LIMS, and Data Historians with our proven methodology.
  • And more


Ensuring a compliant and validated system does not stop after implementation - especially in our more digitalized world. While the cloud has made many aspects of Life Science more efficient, it also brings forced updates and releases. With the right knowledge, you can assure that these updates will only work to make your system better.

Operations services can include:

  • Application Lifecycle Management: Manage GxP systems on-prem and in the cloud.
  • Compliance best practices: Maintainregulatory compliance with confidence.
  • Change and release management: Ensuresmooth transitions and minimize disruptions.
  • And more

Data Analytics and Insights

Process understanding and data mapping are key to enable data-driven operations as part of the overall digital transformation.

Our team of experts are capable to support the definition of a holistic data management strategy to leverage the existing data sources.

Data Analytics & Insights services can include:

  • Data management strategy: Develop aholistic plan to leverage your existing data sources.
  • Unified Manufacturing Data Model (UMDM):Create a central repository for actionable insights.
  • Data quality & consistency: Ensureaccurate and reliable data for informed decision-making.
  • Real-time data visualization: Gaininstant insights into your manufacturing operations.
  • GxP & non-GxP data platforms: Support processes like CPV, process monitoring, etc.
  • And more

Our Customer Cases

Get in touch

We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.