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Our service offers a meticulous evaluation of the entire QMS landscape, ensuring alignment with global regulatory standards set forth by the FDA, EMA, and WHO. We conduct a comprehensive review of SOPs governing key Quality activities such as: Non-conformance Management, Change Controls, CAPA, Market Complaints, Qualifications and Validations, Training Management, and Batch Release processes.
Our team conducts a detailed analysis of existing SOPs related to Quality activities, assessing their content, clarity, and alignment with regulatory requirements and industry best practices.
Through systematic evaluation, we identify gaps and deficiencies within the SOPs, comparing them against international references and regulatory guidelines.
Our experts analyze identified gaps to determine their impact on compliance, risk management, and overall quality performance within the organization.
Based on the findings of the GAP assessment, we develop tailored recommendations and action plans to address identified deficiencies and improve SOP content.
Our recommendations focus on enhancing SOPs to align with international standards, addressing GAPs in compliance, improving process efficiency, and strengthening overall quality management practices.
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.
