GxP Compliance for Computerized Systems



GxP webinar 

How to ensure GxP Compliance for Computerized Systems 

Watch on demand by filling out the form to the right

Join our webinar about GxP Compliance for computerized systems, where we will look at how to ensure compliance during implementation and maintenance of computerized systems in regulated industries like pharma, biotech and medical device.  
We will discuss how to improve the process for GxP assessment and documentation which can be relevant when 

  • implementing a new IT solution 
  • using an existing IT solution 
  • or ensuring inspection readiness 


This topic is important due to the increasing focus on GxP compliance for computerized systems by the FDA*. HERAX can assist in ensuring GxP compliance and correctly documenting IT solution(s) in an efficient and structured way. 


*(FDA: Guidance for Industry - Computerized Systems Used in Clinical Trials) 

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LRA-(v4.00)Line Rasmussen
Project Manager

Line has 5 years of experience in Pharma as a project manager and senior consultant. She specializes in GxP compliance, process optimization, organizational change management and project management. Line has an analytical mindset, is highly structured and holds certificates in Prince II, Business Strategy and Financial Performance and GAMP5. 




Jakob Schmidt
Business Analyst 


Jakob is a pharma business and IT consultant. He specializes in validation and compliance. He also works with analyzing and optimizing pharmaceutical processes, developing quality documentation, and implementing process improvements. Jakob is focused and takes initiative to drive projects forward, working with people in all levels of an organization. He is highly motivated to solve problems with a high level of quality, driven by a strong analytical mindset. Jakob holds certificates for PRINCE II, GAMP5 and LEAN.