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Siedlerstraße 7 | 68623 Lampertheim, Germany

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QMS Audit Readiness – Full Program Implementation

Zamann Pharma Support offers a comprehensive consultancy, encompassing all aspects necessary to ensure the readiness of clients’ QMS for regulatory audits. Our service includes the provision of essential documents such as SOPs, templates, and checklists to establish the framework for QMS Audit Readiness. Additionally, we conduct evaluations of Quality processes to ensure compliance with regulations, mock audits and trainings for client teams to enhance their readiness and response capabilities.

The researchers are working in a chemical laboratory.

Documentation Development

We develop and provide the necessary documentation, including SOPs, templates, and checklists, tailored to the client’s QMS and regulatory requirements. Our team ensures alignment between documentation and industry best practices, serving as the foundation for the audit readiness program.

Process Evaluation and Compliance Assessment

Zamann conducts thorough evaluations of the client’s quality processes to assess compliance with regulatory standards and identify any areas requiring improvement. We analyze existing procedures, workflows, and controls to ensure alignment with applicable regulations and industry guidelines, addressing any gaps or deficiencies as needed.

Mock Audits and Trainings

Our service includes mock audits execution to simulate real-world audit scenarios and assess the effectiveness of the QMS in meeting regulatory requirements. We provide customized trainings and workshops for client teams to enhance their understanding of audit readiness principles, regulatory requirements, and best practices. Zamann facilitates interactive sessions and practical exercises to prepare staff for audits, empowering them to effectively respond to auditor inquiries and ensure compliance with regulatory standards.

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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