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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Periodical Internal Audits – Strategy Creation

Specialized services dedicated to support clients with necessary know-how to execute Internal Audits effectively. We provide comprehensive services to develop the necessary documentation, including SOPs, templates, and workflows, aligned with applicable regulations. Our focus is on empowering clients with the knowledge and tools required to conduct periodic Internal Audits with precision and compliance.

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Regulatory Compliance Assessment

We conduct a detailed analysis of relevant regulations, such as FDA and EMA guidelines, to identify requirements for Internal Audit activities.

Our experts assess regulatory expectations regarding internal audit processes, documentation, and reporting, ensuring alignment with industry standards.

Development of Audit Strategy and Documentation Framework

Collaborating closely with clients, we develop a customized audit strategy outlining the objectives, scope, frequency, and methodologies for internal audits.

We create comprehensive documentation frameworks, including SOPs, audit checklists, templates, and workflows, to guide internal audit processes effectively.

Training and Implementation Support

Zamann provides training sessions to educate personnel on internal audit best practices, regulatory requirements, and the use of developed documentation.

We offer ongoing support and guidance during the implementation of the audit strategy and documentation framework, ensuring successful integration into the client’s quality management system.

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.

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