QMS Audit Readiness – GxP Audit Execution
We offer expert audit services both on-site and remotely to thoroughly assess clients’ QMS activities. Our focus is on evaluating compliance with international references such as FDA and EMA guidelines. Through meticulous examination of all aspects of the QMS, we ensure alignment with regulatory standards and industry best practices, providing clients with valuable insights to enhance their Audit Readiness.
Comprehensive Audit Planning
We develop detailed Audit Plans customized to the client’s QMS and regulatory requirements, outlining the scope, objectives, and audit methodology.
Our team identifies key areas for review, including documentation, procedures, processes, and controls, ensuring thorough coverage of all relevant aspects.
On-Site and Remote Audits
Zamann conducts both on-site and remote audits, depending on client needs and circumstances, utilizing a combination of site visits, interviews, and document reviews.
We employ a risk-based approach to prioritize audit activities, focusing on critical areas that pose the greatest compliance risk to the QMS.
Audit Reporting and Follow-Up
Following the audit, we provide comprehensive reports detailing findings, observations, and recommendations for corrective actions.
Our team works closely with clients to develop action plans to address identified deficiencies and improve QMS compliance.
Zamann offers ongoing support and guidance to ensure effective implementation of corrective actions and continuous improvement in Audit Readiness.
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.
