Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Specialized consultancy related to GAP Assessment execution, to evaluate the implemented process to Batch Record Review, to identify any discrepancies with applied regulations such as FDA and EMA guidelines. Our services aim to pinpoint GAPs in compliance and provide actionable insights to enhance processes and ensure regulatory alignment, thereby safeguarding product quality and regulatory adherence.
We conduct a thorough analysis of necessary regulations pertaining to Batch Record Review processes, identifying specific requirements and expectations.
Our experts assess the existing batch record review process against these regulatory standards to pinpoint areas of non-compliance or potential GAPs.
Zamann team performs a comprehensive GAP analysis to compare the current state of Batch Record Review processes with regulatory requirements.
We review existing documentation, procedures, and quality records related to the activity to identify discrepancies or deficiencies in compliance.
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 batch record review processes.
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.
