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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Periodical Internal Audits – Strategic Consultancy

Strategic consultancy for Periodical Internal Audits, providing pharmaceutical companies with guidance on establishing robust Internal Audit frameworks. Our service focuses on developing the landscape for Internal Audit activities, including the creation of essential SOPs or the evaluation of existing processes to drive improvement. We empower companies to initiate or enhance their Internal Audit programs, ensuring compliance and continual quality improvement.

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Development of Internal Audit SOPs

We work closely with our clients to understand their organizational structure, processes, and regulatory requirements. Based on this understanding, we develop comprehensive Standard Operating Procedures (SOPs) specifically tailored for conducting internal audits.
These SOPs outline the scope, objectives, responsibilities, and procedures to be followed during internal audits, ensuring consistency and effectiveness across all audit activities.

Audit Program Design

Our team collaborates with clients to design customized internal audit programs that meet their specific needs and regulatory obligations. We begin by defining the audit schedule, taking into account factors such as the size of the organization, the complexity of operations, and regulatory requirements.
We assist in selecting appropriate audit criteria and establishing risk-based approaches to prioritize audit focus areas, ensuring that audits address the most critical areas of concern.

Training and Skill Development

We offer training sessions and workshops designed to enhance the skills and knowledge of internal audit teams, covering aspects of audit techniques, planning, execution, and reporting. We also provide guidance on documentation requirements, emphasizing the importance of accurate and complete audit documentation for compliance purposes. Additionally, we focus on developing communication skills to facilitate effective interactions with auditees and stakeholders, fostering a culture of quality and compliance within the organization.

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Periodical Internal Audits – Strategy Definition

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Periodical Internal Audits – GAP Assessment

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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