Change Control – Strategy Definition
Our service empowers pharmaceutical companies with the necessary technical infrastructure to effectively implement Changes Control process, ensuring compliance with international regulations. Our experts collaborate with clients to develop comprehensive strategies that encompass policies, standard operating procedures (SOPs), and executional templates customized to their specific needs.
Strategy Development and Documentation
We work closely with the client to develop a tailored strategy for change control management, focusing on defining clear objectives, roles, responsibilities, and escalation pathways.
Our team assists in documenting the strategy into detailed policies, SOPs, and templates, ensuring alignment with regulatory requirements and industry best practices.
Training and Capacity Building
We conduct targeted training sessions to equip stakeholders with the necessary knowledge and skills to implement the new change control processes effectively.
Our training programs cover topics such as change initiation, evaluation, approval, implementation, and verification, fostering a culture of compliance and accountability within the organization.
Implementation Support and Guidance
We provide hands-on support throughout the implementation phase, offering guidance and expertise to ensure smooth execution of the new change control processes.
Our team assists in addressing any challenges or obstacles encountered during implementation, helping the client navigate complexities and achieve successful integration of the strategy into their operations.
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.
