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Reckitt
BIONTECH
ratiopharm
SANOFI
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STORCK
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Our service identify and address GAPs between their existing knowledge management processes and the regulatory requirements outlined by authorities such as FDA, EMA, and WHO. We conduct comprehensive assessments to evaluate the effectiveness, compliance, and maturity of current knowledge management practices, identifying areas for improvement and alignment with industry standards.
We conduct a detailed analysis of the organization’s current knowledge management processes, including documentation, workflows, systems, and practices.
This involves reviewing existing policies, procedures, SOPs, tools, and technologies to identify strengths, weaknesses, and potential gaps in compliance with regulatory requirements.
We assess the organization’s knowledge management practices against relevant regulatory guidelines and standards, including FDA, EMA, and WHO requirements.
This involves comparing existing processes and documentation with regulatory expectations, identifying areas of non-compliance or deviation, and determining corrective actions needed for alignment.
Based on the assessment findings, we perform a comprehensive gap analysis to identify discrepancies between current practices and regulatory requirements.
We provide detailed recommendations and action plans to address identified gaps, including updates to policies, procedures, systems, and training programs, aiming to enhance compliance, efficiency, and effectiveness in knowledge management.
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.
