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 references such as FDA and EMA, alignment with company SOPs, and the accuracy of records and evidence.
Documentation Review and Verification
Our auditors scrutinize all relevant documentation, including change requests, impact assessments, approval records, and change implementation reports, to ensure they meet regulatory requirements and internal SOPs.
We verify the accuracy, completeness, and timeliness of documentation to ascertain if the change control process has been properly documented and executed.
SOP Adherence Assessment
We assess the company’s adherence to its own standard operating procedures (SOPs) governing the change control process.
Our auditors evaluate whether the procedures outlined in the SOPs are being followed consistently across departments and functions, identifying any deviations or discrepancies that may indicate non-compliance.
Process Evaluation and Compliance Check
We conduct a comprehensive evaluation of the entire change control process workflow, from initiation to closure, to ensure compliance with regulatory standards and industry best practices.
Our auditors verify if the change control process is effectively managing changes, assessing risks, obtaining necessary approvals, and implementing changes in a timely and controlled manner, highlighting any areas of non-compliance and providing recommendations for improvement.
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.
