Change Control – Audit Execution
By conducting focused audits, we support pharmaceutical companies to ensure the effectiveness and compliance of their Change Control processes. Our expert auditors meticulously review various aspects, including adherence to international regulatory references such as the FDA and EMA, alignment with company SOPs, and the accuracy of records and evidence. We utilize a systematic approach to evaluate each component of the change control process, identifying potential risks, areas of improvement, and ensuring that all changes are documented accurately. This comprehensive auditing service strengthens quality management systems and promotes regulatory compliance across the organization.
Documentation Review and Verification
Our auditors scrutinize all relevant documentation related to the change control process, including change requests, impact assessments, approval records, and change implementation reports. This thorough review ensures that all documentation meets regulatory requirements as well as internal SOPs. We verify the accuracy, completeness, and timeliness of the documentation to ascertain whether the change control process has been properly documented and executed. This attention to detail not only ensures adherence to industry standards but also enhances accountability and transparency in the change control process, ultimately contributing to better quality management.
SOP Adherence Assessment
We assess the company’s adherence to its own standard operating procedures (SOPs) governing the change control process comprehensively. Our auditors evaluate whether the procedures outlined in the SOPs are consistently followed across all departments and functions within the organization. By identifying any deviations or discrepancies that may indicate non-compliance, we provide valuable insights into areas that require corrective action. This assessment helps ensure that all personnel involved in the change control process understand and adhere to established protocols, resulting in a more effective and compliant operational framework.
Process Evaluation and Compliance Check
We conduct a comprehensive evaluation of the entire change control process workflow, from initiation to closure, ensuring compliance with regulatory standards and industry best practices. Our auditors verify if the change control process is effectively managing changes by assessing risks, obtaining necessary approvals, and implementing changes in a timely and controlled manner. We identify areas of potential non-compliance and provide actionable recommendations for improvement. This thorough evaluation not only enhances the integrity of the change control process but also strengthens the organization’s overall quality assurance measures and regulatory compliance efforts.
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.
