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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Periodical Internal Audits – GAP Assessment

Zamann Pharma Support offers specialized consultancy dedicated to evaluating the existing Internal Audit processes, to identify potential discrepancies with applied regulations (e.g.: FDA and EMA). Additionally, our service provide actionable insights to enhance processes and ensure regulatory alignment.

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Regulatory Compliance Evaluation

We conduct a comprehensive analysis of FDA and EMA regulations pertaining to internal audit processes, identifying specific requirements and expectations.

Our experts assess the existing internal audit process against these regulatory standards to pinpoint areas of non-compliance or potential gaps.

GAP Analysis and Documentation Review

Zamann performs a detailed GAP analysis to compare the current state of internal audit processes with regulatory requirements.

We review existing documentation, procedures, and quality records related to internal audits to identify discrepancies or deficiencies in compliance.

Recommendations and Action Plan Development

Based on the findings from the GAP assessment, we provide actionable recommendations and develop a strategic action plan to address identified GAPs.

We collaborate closely with clients to prioritize corrective actions, implement process improvements, and enhance regulatory compliance in internal audit processes.

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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