Risk Management & Audit Program Services

Risk Management & Audit Program Services

Risk-based auditing is an approach to auditing that focuses on identifying and prioritizing areas of risk. Risk-based auditing is driven by the level of risk associated with a particular area or process within the organization.

Using the GxP Solutions methodology, your organization can optimize your GxP audit program to reduce costs, focus on high-risk suppliers / Vendors during audit scheduling, identify high-risk internal system and process audits, or focus on high-value topics when conducting an audit.

• Risk-Based Audit Scheduling

GxP Solutions can help develop risk management procedures and risk tables that can assist you in developing a strategy for GxP supplier/vendor audit scheduling by prioritizing high-risk suppliers/vendors, minimizing auditing costs, and focusing auditor attention on the areas that matter most and providing assurance and insight to management.

• Auditor Efficiency and Effectiveness

GxP Solutions’ risk-based approach to audit scheduling will auditors improve their efficiency and effectiveness. By focusing their audits on processes or systems that show elevated risk levels. Rather than wasting time and effort on low-risk / low-value areas, auditors can concentrate on the high-risk / high-value processes or systems that require additional attention and scrutiny.

GxP Solutions can provide the following services:

• Help you understand your vendors/suppliers’ risk.
• Involve Management in developing a better management strategy.
• Conduct supplier risk assessments.
• Develop and audit scheduling plan.
• Execute the audit program.
• Report and communicate vendor/supplier audit findings.
• Response review and assessment.
• Corrective And Preventive Action (CAPA) follow-up.