Audit Program Governance

The computerised system validation audit strategy, is a deliverable that can be presented during inspections or audits. It provides the method taken to define a risk-based approach to audit planning.

Our consultants can help by defining your:

• CSV Audit Strategy and risk-based approach
• Risk factors that will influence and quantify the risks across your audit universe
• Audit universe, covering both internal and external audit candidates, in addition to maintaining it

Utilising a risk-based approach, helps focus the development and maintenance of the Annual Audit Plan.

Key areas where we can support are:

• Establishing risk values, liaising with stakeholders
• Preparing rationales and audit scopes for potential audit candidates
• Preparing and maintaining the Annual Audit Plan
• Maintaining risk values and updating your plans

Supplier qualification is a key part of the risk-based approach to computerised system validation, ie. leveraging supplier activities.

Projects requiring a supplier assessment must be performed at the right time so that the outcome of the assessment can influence the validation strategy. Our consultant lead auditors can support by supplementing your internal team to manage these peaks and perform these ad hoc requests.

Whether it’s a postal questionnaire, desktop or remote or virtual or on-site audit, our consultant lead auditors can support in the planning, conduct and reporting.

We can also support as co-auditors when you need a specialist as part of your team, for example when an internal process audit relies heavily on technology.

And once the audit is done our consultants can provide support around:

• Confirmation of the Root Cause Analysis
• Adequacy of the corrective and preventive action plans and effectiveness checks
• Monitoring, review of completion of action plans and effectiveness checks

Ensuring that the audit findings and associated risks to your company are properly addressed.