This 1-day course on System Audit will allow you:
- The Regulations and Guidelines to implement a QMS in clinical research
- Understanding the Quality Management System (QMS) in clinical research and their processes
- Using ISO 19011:2018 Guidelines for Auditing Management Systems as a tool to audit systems in clinical research
- Engaging with your stakeholders; ensuring stakeholder buy-in and support
- Deciding which systems to audit by taking a risk based approach
- Understanding the system/process; Process mapping and its benefits in developing system audits
- Scoping the system audit; what to include and how far to go
- Conducting and reporting a system audit
The course includes cases studies, short exercises and a final evaluation to encourage understanding.
Clinical Research requires a robust Quality Management System (QMS) with processes that meet regulatory requirements and the organisation’s objectives. ICH GCP E6 R2 guidelines puts an emphasis on a risk-based approach to clinical trials and audits are an essential component.
Considering which system to audit is essential in the development of a robust audit program. System audits using a Risk Based Approach are designed to seek out those high-risk weaknesses and failures of the process and associated systems. When performed well these audits add tremendous value in identifying systematic risks and issues, and form part of the risk management and monitoring activities of an organization.
The conduct of system audits can be challenging as they require:
- Comprehensive evidence in support of the measurement of compliance, effectiveness and performance of the process/system
- If the audit examines complex activities, then obtaining and interpreting the evidence can be difficult and may require technical expertise for specialised areas.
- No reporting standards exist for a system-based audit because each audit has specific requirements and results.
Clinical auditors will need to have the skills and confidence to embrace these challenges and understand the concept of system audits and their application in the delivery of high quality audits.
This course provides you with the grounding that will allow you to become familiar with the key stages in preparing, developing, conducting and reporting a system audit.