Computer System Validation (CSV) and Electronic Health Records – Tuesday 6th June 2023
Date: 26 April 2023
Computer System Validation (CSV) and Electronic Health Records
Tuesday 06 June 2023 (0930-1700) | Seminar Room, Edinburgh Clinical Research Facility Edinburgh
This one-day 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’ 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.
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
Tutors: Siobhan Lim Consulting/ Paul Cross Consulting
Course Fee: £295.00
Registration: Please register via the following URL https://edin.ac/3M2PC9v