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Our specialized consultancy services focus on executing GAP assessments to evaluate the implemented processes for batch record review. We are committed to identifying discrepancies with regulatory guidelines, including those from the FDA and EMA. Our objective is to pinpoint gaps in compliance and provide actionable insights to enhance processes, ensuring regulatory alignment while safeguarding product quality. By conducting thorough assessments, we enable organizations to preemptively address compliance issues and maintain high standards in their batch record review practices.
We conduct a thorough analysis of necessary regulations pertaining to batch record review processes, identifying specific requirements and expectations that need to be met. Our experts carefully assess the existing batch record review processes against these regulatory standards, allowing us to pinpoint areas of non-compliance or potential gaps. This rigorous evaluation is crucial for understanding the legal obligations organizations must fulfill. By identifying these regulatory nuances, we empower clients to align their practices with industry standards, thus enhancing their overall compliance posture.
The Zamann team performs a comprehensive GAP analysis to compare the current state of batch record review processes against established regulatory requirements. We carefully review existing documentation, procedures, and quality records related to batch record reviews to identify any discrepancies or deficiencies in compliance. This methodical analysis allows organizations to gain valuable insights into their operational frameworks and highlight where improvements are needed. By addressing these identified gaps, clients can strengthen their processes and uphold regulatory compliance across their operations.
Based on the findings from the GAP assessment, we provide actionable recommendations and develop a strategic action plan to address identified gaps in the batch record review process. We collaborate closely with clients to prioritize corrective actions, implement process improvements, and enhance regulatory compliance. Our goal is to ensure that all recommendations are practical and aligned with the organization’s operational capabilities, allowing for a seamless integration of new processes. By working together, we help organizations navigate compliance challenges, driving continuous improvement and maintaining product quality.
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.
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.
