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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Batch Record Review – Strategy Definition

We provide expert consultancy, emphasizing documentation creation to enable companies to effectively perform Batch Record Reviews in line with regulations. We provide customized services to develop comprehensive review protocols, templates, and documentation frameworks, empowering clients to execute batch record reviews efficiently while ensuring compliance and product Quality.

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Development of Standard Operating Procedures (SOPs)

We collaborate closely with clients to develop detailed SOPs outlining the step-by-step procedures for conducting batch record reviews.

Our experts ensure that SOPs are comprehensive, clear, and aligned with regulatory requirements, providing a standardized approach to batch record review processes.

Creation of Documentation Templates

Zamann assists in creating customized templates for documenting Batch Record Review findings, observations, and corrective actions.

These templates are designed to streamline the documentation process, ensuring consistency and completeness in review documentation.

Establishment of Documentation Frameworks

We help establish documentation frameworks that outline data requirements, review methodologies, and documentation standards for batch record reviews.

Our team ensures that the documentation frameworks provide guidance on data integrity, compliance with regulatory standards, and best practices for batch record review activities.

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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