QMS Audit Readiness – GxP Audit Execution
At Zamann, we offer expert audit services focused on GxP audit execution, both on-site and remotely, to thoroughly assess our clients’ Quality Management System (QMS) activities. Our primary goal is to evaluate compliance with international references, such as FDA and EMA guidelines, ensuring that our clients meet and exceed regulatory standards. Through a meticulous examination of all aspects of the QMS, we provide valuable insights that enhance our clients’ audit readiness. By identifying areas for improvement, we help organizations optimize their systems and processes for better compliance and operational effectiveness.
Comprehensive Audit Planning
We develop detailed audit plans that are customized to meet the unique QMS and regulatory needs of each client. Our plans outline the scope, objectives, and audit methodology, ensuring all necessary elements are covered comprehensively. The Zamann team identifies key areas for review, including critical documentation, procedures, processes, and controls that are vital to maintaining compliance. This thorough planning is crucial for effective GxP audit execution as it establishes clear expectations and benchmarks for audit performance, ultimately leading to a more streamlined and efficient audit process.
On-Site and Remote Audits
Zamann conducts both on-site and remote audits based on client needs and circumstances, utilizing a combination of site visits, interviews, and document reviews. Our team employs a risk-based approach to prioritize audit activities, focusing on critical areas that pose the greatest compliance risks to the QMS. By adapting our audit methodology to suit the specific context of each client, we can effectively uncover potential issues and provide targeted solutions that enhance their overall audit readiness. This flexibility ensures that our clients receive the most relevant insights and recommendations, no matter the audit format.
Audit Reporting and Follow-Up
After the completion of the audit, we provide comprehensive reports detailing our findings, observations, and actionable recommendations for corrective actions. Our team collaborates closely with clients to develop strategic action plans aimed at addressing identified deficiencies and improving QMS compliance. Emphasizing the importance of follow-up, Zamann offers ongoing support and guidance to ensure effective implementation of corrective actions. Our commitment to continuous improvement in GxP audit execution empowers clients to enhance their QMS while achieving a higher level of audit readiness and regulatory compliance.
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.
