This 1-day course on System Audit will allow you:
- Understanding what a system audit is, the advantages and disadvantages of conducting them
- Engaging with your stakeholders; ensuring stakeholder buy-in and support
- Deciding which systems to audit
- 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.
System audits are a valuable addition to your company audit program. In the new ICH GCP E6 R2 world, a risk-based approach to clinical trials including audits is essential. System audits 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 organisation.
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.
Who should attend
Clinical auditors, other quality professionals and anyone with a professional interest in Clinical Trial System Audits.
- Defining system audits
- Regulations: ICH-GCP E6
- Objective assessment of the advantages and disadvantages of system audits
- Determination of key stakeholders
- Stakeholder engagement
- Risk based approach to system selection for audit
- Process mapping exercise
- Scoping the system audit appropriately
- The system audit plan
- Defining the audit roles and responsibilities
- How to conduct the system audit
- How to write system audit reports that generate action
- Understanding the advantages and disadvantages of system audits
- Understanding how to position these audits for success
- Understanding how to plan conduct and report a system audit
This course covers competencies that are part of the ECCRT Competency Framework:
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (1)
- Data Management and Informatics (1)