QUALITY
Plan your individual quality management system with us
As a full-service provider, we also support you in setting up and maintaining a Quality Management System (QMS) based on individual requirements and needs. This includes professional consulting, planning, documentation, support during audits and inspections, as well as continuous adaptation and improvement. Customized according to your specifications, we ourselves take over functions in your QMS, e.g. as Quality Management- (QM) or Good Distribution Practice (GDP) representative, so that you and your employees can truly experience your QMS.
Consulting and Planning
We will be happy to provide you with comprehensive advice and respond to your specific requirements. After clarifying your needs, we will also take over the planning and design of your QM processes so that you can concentrate on the essentials. Thanks to our experience, our specialist knowledge of the industry and our commitment, we will find the best solution for your request.
- GxP / ISO consulting for pharma and medical technology
- Development of Standard Operating Procedures (SOPs)
- Consulting on EU FMD serialisation
- Support during qualification and validation
Development of QM systems
Flawless quality is more than just a duty in the healthcare industry, it also enables you to take your company to the next level. We take care of the development as well as the monitoring of your processes and your QM system, customized to your needs.
- Setup of a QM system according to EU GMP / GDP and ISO 9001/13485
- Development of Standard Operating Procedures (SOPs)
- Creation of the QM manual, as well as site master files
- Creation of attachments and forms
Managed service for QM functions
After consulting, planning, and setting up your QMS, we don’t stop there. We support you continuously with questions and, if necessary, organize the monitoring of your processes and your QMS.
- Accompaniment of official inspections
- Takeover of QM functions
- Auditing and modernization of QMS
- Carrying out self-inspections
The pharmaceutical industry is characterized by a high level of responsibility towards end customers and stakeholders. We support our customers in meeting this responsibility by setting up and maintaining a reliable QMS.
Christina Larisch — Head of QA
CASE
STUDIES
“In partnership with MSK Pharmalogistic, we have created a QMS that our customers and employees can trust and that strengthens us as a company both internally and externally.” — Frank Sprau, CEO
Structure and maintenance of the QMS. Support in the creation of quality documents and SOPs, as well as monitoring compliance in accordance with quality management. Documentation and archiving of quality management processes.
CASE STUDIES
“In partnership with MSK Pharmalogistic, we have created a QMS that our customers and employees can trust and that strengthens us as a company both internally and externally.” — Frank Sprau, CEO
Our contribution
Structure and maintenance of the QMS. Support in the creation of quality documents and SOPs, as well as monitoring compliance in accordance with quality management. Documentation and archiving of quality management processes.
ARE YOU READY TO BRING YOUR QUALITY TO THE NEXT LEVEL?
