Non-Conformity Management– Audit Execution
We conduct comprehensive audits to evaluate the adherence between international regulatory standards (FDA and EMA) and internal SOPs, regarding Management of Non-Conformity issues (Deviations, Incidents, and Investigations). Our expert team meticulously examines the background of activities, SOPs, records and evidences, to evaluate the scenario and propose adaptions, ensuring alignment with regulatory requirements.
Activity Background Verification
We conduct a thorough review of the background of non-conformity activities, including the documentation, procedures, and processes followed by the company. This involves verifying the alignment of activities with international regulatory references such as FDA, EMA, and WHO guidelines to ensure compliance and identify any discrepancies.
SOP Adherence Assessment
Our team evaluates the company’s adherence to its own Standard Operating Procedures (SOPs) for managing non-conformity incidents. We assess whether the documented procedures are being followed effectively and identify any deviations from established protocols or procedural controls.
Record and Evidence Review
We meticulously review records and evidence associated with non-conformity incidents to determine the effectiveness of corrective actions taken by the company. This includes verifying the completeness, accuracy, and timeliness of documentation, as well as ensuring that corrective measures are implemented in accordance with regulatory requirements and best practices.
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.
