Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
Strategic consultancy services for Change Control, guiding pharmaceutical companies in establishing an effective landscape for managing changes to their systems and processes.
We provide expertise in creating necessary SOPs and evaluating existing processes to enhance efficiency and compliance. Our focus is on providing comprehensive guidance and support to develop strategies for effective Change Control management, ensuring regulatory compliance and minimizing risks.
We conduct thorough assessments of the client’s existing change control processes, including SOPs, workflows, and documentation. This involves identifying GAPs, inefficiencies, and areas for improvement through comparison with regulatory requirements and industry best practices.
Our expert team will develop new or revise existing SOPs for Change Control management. This includes defining clear procedures for initiating, reviewing, approving, and implementing changes, ensuring alignment with regulatory guidelines and organizational needs.
We provide customized training sessions and workshops to empower personnel with the knowledge and skills needed to effectively manage change control processes. This includes educating staff on change control principles, procedures, and tools, fostering a culture of accountability and continuous improvement within the organization.
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.