Today global regulatory agencies now expect manufacturers to be more risk-focused and “self-regulated” by implementing robust internal audit programs. By identifying any deficiencies now, before the regulators do, your organization can reduce the risk of enforcement actions/license suspensions.
Supplementing manufacturers’ full-time resources, IQVIA can provide support for your audit programs, including internal, external (supplier) and mock regulatory agency audits. Our auditors bring key industry experience and impartiality to the processes they audit. Their expertise is further supported by enterprise quality management technology that improves audit program efficiency and effectiveness.
In order to achieve an optimized and harmonized auditing program that promotes continuous improvement and delivers a return on investment, it is important to evaluate the current audit program and practices against these elements. The IQVIA approach includes activities to:
- Identify the gaps between current practices and the robust audit program elements
- Document recommendations for addressing each gap
- Prioritize the recommendations, considering expected return to the organization and ensure full compliance with the latest regulatory and technology requirements
Well-run audit programs can be a valuable asset to an organization, particularly when they reveal insights that enable companies to make better business decisions.
Contact us and let’s put our expertise to work for you.