Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
Our routine support provides hands-on support to evaluate, implement, and document changes to systems, processes, and procedures, ensuring compliance with regulatory requirements and industry standards. We help companies navigate through Change Control activities and maintain operational excellence while minimizing risks.
We assist in evaluating incoming change requests, prioritizing them based on risk assessment criteria and business impact analysis. Our team collaborates with stakeholders to review proposed changes, assess their potential impact on quality, safety, and compliance, and determine the appropriate level of scrutiny and review required.
We provide support in implementing approved changes, ensuring adherence to established procedures and documentation requirements. Our experts assist in updating relevant documents, such as SOPs and validation documentation, to reflect the approved changes accurately. We oversee the execution of change tasks, track progress, and verify completion to ensure timely implementation.
We work with companies to identify opportunities for optimizing their change control processes and procedures. Our team conducts assessments to evaluate the effectiveness of existing change management practices, identifying areas for improvement and recommending strategies for enhancing efficiency, consistency, and compliance.
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.