QM-Systems
We support you in optimizing your workflows and processes to make them even more efficient.
Optimize workflows and processes to effectively utilize resources
Holders of a manufacturing authorization for medicinal products according to §13 AMG (GMP), as well as wholesale dealers in medicinal products according to § 52a AMG (GDP) and sponsors of clinical trials (GCP), must have a comprehensive and specifically implemented quality management system. Different requirements apply to the various GxP areas.Especially smaller companies that are beginning to establish GxP systems often face a major challenge. However, even companies with existing systems sometimes need an ‚external view‘ to optimize workflows and processes and make them even more efficient.
We support you in building up or expanding, as well as optimizing your quality management system based on a comprehensive GAP analysis, which enables us to establish a system tailored to your company and your needs.
Our Experts assist you with:
creation and review of SOPs and other QM-related documents
implementation or optimization of processes in the areas of deviation, change control, CAPA, and OOx – management
training of your employees
implementation of quality risk management requirements
qualification of equipment, rooms, and facilities
validation of processes and methods
conducting batch record reviews
Our experts are available to support you in your daily work with the continuous implementation of regulatory requirements, either for a limited or indefinite period of time.
Our support
Do you need support or have questions?
Our team is at your disposal and will be happy to advise you on topics related to quality management systems, analyses, certifications, and regulatory issues.
Free initial consultation
Analysis & planning
Implementation & Training
From planning to execution
How we work
Our processes are precisely coordinated with each other, ensuring a smooth implementation process. We will guide you step by step through all relevant topics and provide you with individual and comprehensive advice.