Clinical Research Computer Systems Validation & Electronic Health Records Workshop

Computer Systems Validation & Electronic Health Records

One day workshop

Who Should Attend

This workshop is designed for NHS / Academic staff who are involved in managing quality systems which comply with the ‘UK Policy Framework for Health & Social Care Research’ and/or the regulations required for clinical trials of medicinal products or medical devices. 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.


It will be an interactive day with a combination of presentations, discussions and workshop. By the end of this workshop, participants will be able to:

  • Define the purpose of computer systems validation (CSV) and understand the regulatory requirements
  • 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
  • Develop a validation report
  • Assess your current organisational strategy regarding the validation of Electronic Healthcare Records
  • Undertake a high-level gap analysis and initiate the computer systems validation process for key hospital systems


As it is only 1 day pre reading is required prior to attendance.


Tues 04 Oct 2022

Online via Zoom

2022 Fees

£355 (excl. VAT) per person - NHS & Academic

© 2022 Siobhan Lim Consulting VAT Reg: GB 157 7017 02