Computer Systems Validation and Electronic Healthcare Records

The MHRA released a position statement in December 2015 detailing their requirements for Electronic Health Records (EHRs) – reference available here. As NHS Trusts move towards electronic health records and away from paper notes, it is essential that regulatory requirements are considered. EHR systems are now becoming the principal source of data and information for participants in research studies; including those regulated by the MHRA.

Computer Systems Validation is an important process which enables you to demonstrate that any of the computer systems you use within your trials are fit for purpose. Paul Cross Consulting and Siobhan Lim Consulting are pleased to announce that we have developed a workshop around CSV and EHR. This workshop covers everything you need to know about CSV in order to remain compliant with the MHRA’s requirements.

The workshop is designed for NHS and academic staff who are involved in managing quality systems, for example, quality assurance managers, research governance managers, clinical research associates, monitors, trial managers, project managers and R&D staff. Management staff, responsible for supervising quality assurance staff or managing oversight of research activity, will also find this workshop of interest.


Course objectives

Upon completion of this workshop you will be able to:

  • Understand and define the purpose of computer systems validation and understand the regulatory requirements
  • Assess your current organisational strategy regarding the validation of Electronic Healthcare Records
  • Understand how to apply CSV requirements to Electronic Healthcare Records in a hospital setting
  • Plan and undertake a CSV risk assessment, develop a validation master plan, understand the requirements of user acceptance testing and develop a validation report
  • Undertake a high-level gap analysis and initiate the computer systems validation process for key hospital systems


You can find further information on the course here.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.