Auditing Computerised Systems

Course Information

Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP).

Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation.

Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course.

Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance.

• Apply risk management techniques to audit planning
• Plan and conduct computerised system audits
• Assess system validation documentation to verify compliance
• Evaluate data integrity and security issues
• Prepare for regulatory inspection.

The course is structured to encourage delegates to:

• Discuss and develop ideas

• Solve specific problems

• Understand the vulnerabilities of computerised systems

• Learn how to create a compliance checklist

• Link system development with good business practice.

Is this course for you?

• Auditors

• Audit programme managers

• Individuals subject to audits.

Tutors

Tutors will be comprised of (click the photos for biographies):

Nichola Stevens

Director and Principal Consultant, Nuncius Compliance Solutions Ltd

Barry McManus

Consultancy Partner, Empowerment Quality Engineering Ltd

Programme

Please note timings may be subject to alteration.

Day 1

09:00

Welcome and Introductions

09:45

Why We Validate and Regulatory Trends

10:30

Break

10:45

Audit Overview, High Level Process and Scheduling

11:30

System Lifecycle

12:30

Lunch

13:15

Exercise 1 - Audit Scheduling

14:45

Exercise 1 - Feedback

15:15

Break

15:30

Validation Deliverables

16:30

Risk Assessments

17:30

Close of Day 1

Day 2

09:00

Supplier Assessment

10:30

Break

10:45

Exercise 2 - Planning a Supplier Audit

12:00

Exercise 2 - Feedback

12:30

Lunch

13:15

Exercise 3 - Auditing a Computerised System Validation Package

15:30

Break

15:45

Exercise 3 - Feedback

16:30

Change Control

17:15

Close of Day

Day 3

09:00

Infrastructure Qualification

09:45

Maintaining a Validated State - Operational Processes

11:00

Break

11:15

Exercise 4 - Auditing Systems in Operational Use

12:45

Lunch

13:30

Exercise 4 - Feedback

14:15

Exercise 5 - Auditing Trail Review

15:30

Break

15:45

Exercise 5 - Feedback

16:15

Course Objectives Summary and Any Additional Questions

16:45

Close of Course