Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Support in executing a hands-on assistance to ensure thorough review processes, compliance with regulatory standards, and timely identification of any discrepancies or deviations. By leveraging our expertise, companies can enhance the Quality and integrity of their Batch Records, contributing to overall product quality and regulatory compliance.
We work closely with our clients to prepare and execute internal audits tailored to their strategic goals and compliance objectives. This involves defining audit scope, objectives, and criteria in line with company priorities. Our team conducts thorough audit planning, including selecting audit teams, scheduling activities, and ensuring resources are allocated appropriately.
Following internal audits, we assist companies in developing robust Corrective and Preventive Action (CAPA) plans informed by audit findings. Our experts analyze audit results to identify areas for improvement and formulate targeted CAPAs to address identified non-conformities and prevent recurrence. We collaborate with clients to prioritize CAPAs, establish timelines, assign responsibilities, and track progress to resolution.
We provide ongoing support to ensure compliance with CAPA plans and regulatory requirements. Our team conducts regular follow-up activities to monitor the implementation of CAPAs, verify effectiveness, and address any emerging issues. We assist in tracking CAPA progress, evaluating outcomes, and adjusting strategies as needed to achieve sustainable compliance and continuous improvement.
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.
