Non-Conformity Management– GAP Assessment
Our service is designed to help pharmaceutical companies evaluate their existing quality processes related to deviations, incidents, and investigations through a focused non-conformity gap assessment. We thoroughly assess current practices and procedures, allowing us to suggest meaningful improvements. This is achieved by mapping applicable international regulatory standards, such as those set by the FDA and EMA, while conducting a detailed evaluation of the related Standard Operating Procedures (SOPs) and records. By identifying any gaps in compliance and effectiveness, we can collaborate with clients to create a comprehensive Corrective and Preventive Action (CAPA) plan that addresses these deficiencies and aligns the company’s practices with regulatory requirements.
Regulatory Reference Mapping and Review
We meticulously review and analyze all applicable regulatory references, including guidelines from the FDA, EMA, and WHO, to ensure a comprehensive understanding of the requirements related to non-conformity management. This process involves identifying key regulations, standards, and best practices that are relevant to managing deviations, incidents, and investigations within the pharmaceutical industry. By conducting this thorough mapping and review, we provide clients with a clear framework that outlines their obligations and expectations under various regulatory standards. This foundational understanding is essential for effectively addressing any gaps identified during the assessment process and ensuring compliance.
SOP and Record Evaluation
We conduct a detailed evaluation of the company’s existing Standard Operating Procedures (SOPs) and records that pertain to deviations, incidents, and investigations. This evaluation includes assessing the adequacy, completeness, and compliance of these SOPs and records with regulatory requirements and industry standards. Our focus is on identifying any gaps or deficiencies in documentation and procedural controls that could lead to non-conformities. By thoroughly analyzing these critical components, we ensure that organizations have the necessary documentation in place to support effective non-conformity management and compliance with regulatory expectations, ultimately enhancing their operational integrity.
CAPA Plan Development
Based on the findings from our non-conformity gap assessment, we work closely with the client to develop a comprehensive Corrective and Preventive Action (CAPA) plan that addresses identified deficiencies and non-compliances. This process involves prioritizing corrective and preventive actions to ensure that the most critical issues are addressed first. We also define clear timelines and responsibilities for implementation, ensuring that all actions align with regulatory requirements and best practices. By developing a robust CAPA plan, we help organizations enhance their quality processes and compliance readiness, ultimately fostering a culture of continuous improvement and operational excellence.
Customized support for Quality Management Systems
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.
Why Zamann?
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.
