Test & Validation

Find your perfect balance between compliance risk and business efficiency

Life Science companies constantly face updates in technology, regulations, and business initiatives. With all these changes, it can be difficult to find the balance between risk and efficiency that allows you to achieve business goals and maintain compliance.

With our Compliance and Validation services, Epista can help your business reach its goals and ensure regulatory compliance. From defining validation strategies to system implementation and operations, we can fill knowledge gaps or enhance your internal competences.

We are well equipped to address your needs effectively: Our team of experts melds profound industry insight with extensive experience gained from assisting customers globally in identifying, anchoring, and adhering to regulatory requirements. We accomplish this by deeply engaging with your business to guarantee the adoption of not only compliant but also sustainable solutions.

When it comes to IT compliance and associated regulatory demands, we have experts spanning the entire value chain, including R&D, Clinical,Regulatory, Quality, Manufacturing, and Commercial sectors.

We can help you to

  • Identify applicable regulatory requirements, whether it’s pharma, biotech, or medical device(e.g. GxP, MDR, IDMP)
  • Leverage the appropriate frameworks on a level tailored to your business in order to ensure regulatory compliance
  • Scope, develop, and anchor relevant processes (e.g. SOP’s, training) enabling you to become compliant
  • On an interim basis fill roles and perform activities required for your compliance journey to reach its goal of becoming compliant and efficient
Talk to an expert
Emma Hagberg
Managing Director (Consulting DK)


Our team helps ensure that your digitalization journey is fit for your business needs, that is compliant, your IT systems are validated and meet the appropriate level of compliance for both the industry and your business.

Our Strategy and Services can include individual support or an industry expert advising on:

  • Creation and continuity of a robust, agile, and compliant strategy
  • Building the optimal operational model for your business needs
  • Identifying and mitigating potential risks
  • And more...

IT System Implementation

The path towards digitalization and moving your operations to the cloud often requires the implementation of new or updates to existing IT systems.

We are able to provide individual services or industry experts for advisory and/or execution.

IT System Implementation services can include:

  • Project preparation (e.g. project planning, defining test & validation strategy, baselining and harmonizing processes and data)
  • CSV / CSA
  • Test and validation strategy, planning, execution & reporting
  • CAPAs and deviations
  • Vendor Management
  • Project Management
  • 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 that must be handled, timely, for the system to remain compliant.

Operations services can include:

  • Creating and establishing an operations and maintenance model
  • Ensuring best practices for industry compliance
  • Change and release management
  • And more...

AI & Machine Learning

AI and Machine Learning are making a positive impact on Life Science, and they can work for you, too. Whether you already use these tools in your business or are interested in integrating them, Epista can help you make the most of the latest technology.

AI and Machine Learning services can include:

  • Qualification of AI & Machine Learning models
  • Utilizing AI & Machine Learning for compliance, test, and validation
  • Exploration if and how these novel technologies can support your business while remaining compliant

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.