Risk Management – Audit Execution
By performing focused audits, we evaluate the risk management processes to ensure regulatory compliance and effectiveness. Our audits holistically assess the various aspects involved in the activity, ensuring adherence to international references such as the FDA, EMA, and ICH, while also maintaining compliance with internal SOPs. Through this structured approach, we identify key areas for improvement and reinforce compliance within an organization, leading to sustainable operational excellence.
Preparation and Planning
Our auditing process begins with a thorough preparation phase where we meticulously plan the audit. This includes defining the scope, establishing clear objectives, and setting criteria for evaluation. During this stage, we review relevant regulations, guidelines, and internal policies to create a robust audit framework. This comprehensive groundwork allows us to identify critical areas that require assessment, ensuring that the audit is comprehensive and aligned with best practices in risk management.
Auditing
Our team of experienced auditors conducts both on-site and remote audits to thoroughly assess the implementation and effectiveness of the risk management processes. This phase includes interviewing key personnel, reviewing essential documentation, and observing procedures firsthand to verify compliance with defined regulatory requirements and internal standards. By employing various assessment techniques, we can deliver a nuanced evaluation that highlights strengths and identifies weaknesses within the current risk management framework.
Audit Reporting and Follow-up
After completing the audit, we compile detailed reports summarizing our findings, observations, and actionable recommendations for improvement. We closely collaborate with our clients to discuss the audit results, address any discrepancies or identified non-conformities, and create corrective action plans aimed at enhancing the risk management landscape. Our team is committed to providing ongoing support to ensure timely resolution of issues, fostering a culture of continuous improvement and compliance with regulatory expectations.
Customized support for Quality Management Systems
Our team collaborates closely with you to create, maintain and improve your Quality Management Systems ensuring a perfect fit between processes and goals. From initial setup to ongoing support, we ensure that every element supports robust holistic compliance, efficiency, and long-term growth.
Why Zamann?
Zamann is committed to building Quality Management Systems that exceed expectations. With a deep understanding of regulatory requirements and global practical expertise, we ensure not only compliance with regulations, but also optimization of QMS´s workflows and continuous improvement.
