Robust Quality Management Systems (QMS) are the heart of our Quality Management. With the right process in place for your business model and the right people managing it, the Quality System will be robust, compliant, easy to navigate and a fantastic tool for trending.
It really is worth spending the time at the beginning of the Quality system build to get the foundations in place, this allows the system to grow.
What is the right way to build a Quality System? The right way is what suits your business best, it could be fully digital, a paper based system or a hybrid system, the most important aspect is that the system encompasses all procedures and processes that are required to ensure the Wholesale Distribution activities are compliant, and the products remains within the legal supply chain.
Many factors are needed within the QMS to name a few:
- Change Management
- Quality Risk Management
- Deviation Management
When building your system, create your processes following the guidance, take the time to get the process and procedures in place and the maintenance will be so much easier!
Training is a big part of the QMS, getting it right, training it out, revisiting it annually if staff are quality minded, trained and competent, the business will remain compliant, strive for continuous improvement and run efficiently and effectively with no compromise to the patient or the product.
For a more detailed look clink the link below and see Chapter 1, 1.2 Quality System. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52013XC1123(01)
If you would to discuss your Quality Management System with one of our team or need help creating your initial QMS please contact us