Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We offer support for the execution of all activities related to Quality System routines, including Batch Record review, Change Control management, CAPA and Deviation management, and Internal Audits execution. With our partnership, we ensure that your Quality Systems remain efficient, compliant, and aligned with best practices, without delays or lack of SOPs adherence.
Our team assists in managing Change Control processes, ensuring that any proposed changes to processes, procedures, or systems are thoroughly evaluated, documented, and implemented in compliance with regulatory standards. We facilitate the review and approval of requests, assess potential impacts on quality, and oversee the execution of approved changes.
We provide support in investigating and managing deviations from established processes or specifications, identifying root causes, and implementing corrective actions to prevent recurrence.
Our consultants guide the deviation investigation process, facilitate cross-functional collaboration, and ensure timely resolution to minimize impact on product quality and compliance.
We assist in the implementation of corrective and preventive actions (CAPAs) derived from deviation investigations, audits, or other quality events. Our team helps develop CAPA plans, track progress, and verify effectiveness, ensuring that identified issues are addressed comprehensively to prevent recurrence and improve overall quality systems.
Our experts ensure that batch records are complete,
accurate, and compliant with regulatory requirements,
identifying any discrepancies or deviations that may
impact product quality or regulatory compliance.
Our team plans, executes, and reports on internal audit activities, identifying areas for improvement, verifying the effectiveness of corrective actions, and ensuring ongoing 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.
