Non-Conformity Management– Audit Execution
We conduct comprehensive audits to evaluate the adherence between international regulatory standards, such as those set by the FDA and EMA, and the internal Standard Operating Procedures (SOPs) of your organization regarding the management of non-conformity issues, including deviations, incidents, and investigations. Our expert team meticulously examines the background of activities, SOPs, records, and evidence to fully assess the scenario. We then propose necessary adaptations to ensure strict alignment with regulatory requirements while improving overall quality management. This holistic approach to audit execution not only mitigates risks but also enhances compliance and organizational performance.
Activity Background Verification
We conduct a thorough review of the background of non-conformity activities, scrutinizing all relevant documentation, procedures, and processes followed by the company. This detailed review involves verifying the alignment of these activities with established international regulatory references, including FDA, EMA, and WHO guidelines. By identifying discrepancies and aligning practices, we ensure organizations build a robust foundation for compliance. Our process not only highlights areas of improvement but also fortifies the overall compliance structure of the company. This proactive approach leads to more accurate reporting and more effective management of non-conformity activities in the future.
SOP Adherence Assessment
Our team evaluates the company’s adherence to its own Standard Operating Procedures (SOPs) for managing non-conformity incidents with meticulous attention to detail. We assess whether the documented procedures are being faithfully followed in everyday operations. This includes identifying any deviations from established protocols or procedural controls, which could compromise compliance and operational efficiency. Our assessment helps in pinpointing gaps in the execution of SOPs, providing organizations with clear insights into areas that require corrective actions. This comprehensive review also fosters a culture of continuous improvement, ensuring that the organization maintains high standards of quality management.
Record and Evidence Review
We meticulously review the records and evidence associated with non-conformity incidents to determine the effectiveness of corrective actions taken by the company. This process involves verifying the completeness, accuracy, and timeliness of all relevant documentation. We ensure that effective corrective measures have been implemented in accordance with regulatory requirements and industry best practices. By accurately assessing documentation, we can identify trends and repeated issues, allowing organizations to address root causes effectively. Our thorough evidence review supports continuous quality improvement while ensuring that corrective actions not only align with compliance standards but also enhance overall operational integrity.
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.
