Case Study
RX-360 Audit with 0 (!) Complaints!
Quality as well as monitoring
Action: We created a suitable quality system and initiated the monitoring of critical parameters throughout the storage plant in conjunction with suitable alarm- and emergency systems.
Customer benefit: The customer can now prove to customers that critical warehouse processes are controlled and that mechanisms exist to systematically deal with e.g. deviations. Also, the customer can continuously document storage conditions for temperature and humidity parameters of his products.
Topic: Storage of genetically modified organisms
Distribo, the logistics service provider of the global company Sartorius, commissioned us to support them, especially with regard to life science products and related requirements for storage, quality assurance and approval for the storage of genetically modified organisms.
Action: Together with the customer, we planned and carried out the necessary conversions/plant construction in accordance with GenTG and GenTSV (German laws and regulations for handling GMOs); we helped build and registered a compliant plant for storing level 1 and 2, obtained permission by the pertinent authority to operate the plants and carry out genetic engineering work, in this case the storage of GMO products.
Customer benefit: Since then, the customer has been able to store products comprising genetically modified organisms of safety levels 1 and 2.
Topic: cryogenic storage
Action: We set up ultra-low temperature storage and carried out appropriate risk analyses for these and other potentially hazardous processes and materials.
Customer benefit: By using different deep-freeze areas, the customer is now able to store high-quality life science products in a controlled manner under precisely defined temperature conditions and can trust his alarming chain in case of emergency.
Topic: Storage of animal by-products
Action: We facilitated the official registration of the customer for the transport and storage of animal by-products
Customer benefit: The customer has received a legal basis for logistical activities with animal by-products.
Topic: Storage of medicinal products according to Good Distribution Practice (GDP)
Action: We implemented regulatory requirements, negotiated with government agencies and adapted internal processes.
Customer benefit: The customer can store medicines at a time of his choosing.
Internalization/Training
Action: In accordance with the customer's desire for an internalization of processes and know-how, we trained and supported the talents recruited for this purpose over a period of time.
The commitment of the newly hired internal team was a deciding factor. Mares ITX provided structure, regulatory orientation, training and implementation support, while the client's staff actively adopted the new processes, integrated them into daily operations and expanded them as needed.
Customer benefit: The processes set up by Mares ITX were now firmly anchored in the company.
Tangible success
The client's team successfully built on the strong compliance foundation for specialized life science and pharmaceutical logistics – a subsequent RX-360 quality audit with a focus on supply chain security and ISO 9001:2015 revealed null (0!) observations.
We congratulate our customer on this unequivocal success!
We are proud to have contributed to this success and thank the management and the internal team for their professionalism and productive collegiality.