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We provide comprehensive support in executing periodical internal audits, offering hands-on assistance to ensure that review processes are thorough and compliant with regulatory standards. Our expertise enables companies to identify and rectify discrepancies or deviations in a timely manner. By leveraging our knowledge and experience, organizations can significantly enhance the quality and integrity of their batch records. This proactive approach not only contributes to overall product quality but also ensures adherence to regulatory compliance, fostering a culture of accountability and continuous improvement within the organization.
Our team collaborates closely with clients to prepare and execute internal audits that are specifically tailored to align with their strategic goals and compliance objectives. This comprehensive process involves defining the audit scope, objectives, and criteria in accordance with the company’s priorities. We emphasize meticulous planning, which includes selecting appropriate audit teams, scheduling activities effectively, and ensuring that necessary resources are allocated appropriately. This structured approach allows for a seamless execution of internal audits, ultimately leading to insightful findings that can drive operational improvements and enhance compliance.
Following the completion of internal audits, we assist companies in developing robust Corrective and Preventive Action (CAPA) plans that are informed by the findings from the audits. Our team of experts meticulously analyzes the audit results to identify specific areas that require improvement and formulates targeted CAPAs to address any identified non-conformities. We work collaboratively with clients to prioritize these CAPAs, establish realistic timelines, assign responsibilities, and track progress toward resolution. This structured approach ensures that corrective actions are effectively implemented, thereby preventing recurrence and enhancing overall operational quality.
We offer ongoing support to ensure compliance with CAPA plans and regulatory requirements following internal audits. Our dedicated team conducts regular follow-up activities to monitor the implementation of CAPAs, verifying their effectiveness and addressing any emerging issues that may arise during the process. By assisting in tracking CAPA progress and evaluating outcomes, we provide valuable insights that help organizations adjust their strategies as needed. This proactive follow-up approach is essential for achieving sustainable compliance and fostering a culture of continuous improvement within the organization, ultimately enhancing overall quality management practices.
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.
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.
