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Our service is meticulously designed to evaluate the existing change control processes implemented by pharmaceutical companies, ensuring their compliance with international regulations such as those established by the FDA and EMA. By conducting a thorough gap assessment, our experts identify potential shortcomings in the current change control strategies. This evaluation provides valuable insights, highlighting specific areas in need of improvement. By leveraging our expertise, organizations can enhance their change control processes, ensuring they are not only compliant but also streamlined and efficient, ultimately supporting the company’s overall operational excellence and regulatory readiness.
We undertake a detailed review of existing documentation related to change control, which includes policies, standard operating procedures (SOPs), and change records. Our goal is to assess the alignment of these documents with regulatory requirements and industry standards. Our team meticulously analyzes the content, clarity, and effectiveness of these documents in facilitating the change control process. By examining these critical components, we identify any deficiencies or inconsistencies that may impact compliance. This rigorous analysis ensures that the documentation accurately reflects the operational processes, ultimately strengthening the overall change control framework.
Our methodology includes conducting a comprehensive evaluation of the change control process workflow, from initiation to closure, to identify potential gaps, bottlenecks, and areas of non-compliance. During this evaluation, our experts thoroughly assess key aspects such as change request handling, impact assessment, risk evaluation, approval workflows, and documentation practices. This systematic approach allows us to pinpoint specific areas that require improvement and enhancement. By identifying these gaps and bottlenecks, we can provide targeted recommendations that facilitate smoother change processes and better compliance with regulatory standards.
As part of our thorough change control gap assessment, we compare our findings against relevant regulatory requirements, guidelines, and industry best practices, such as FDA 21 CFR Part 11, EU GMP Annex 11, and ICH Q10. This rigorous compliance assessment helps ensure that the change control processes align with the stringent standards required by regulatory bodies. Our team compiles a detailed compliance report that highlights identified gaps and offers actionable recommendations for corrective actions. By addressing these discrepancies, organizations can enhance their change control processes, ensuring they not only meet but exceed regulatory expectations.
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.
