My professional experience covers Quality Management Systems (QMS) and especially GMP/GCP/GTP systems, more specifically those dedicated to cell and gene therapy operations. This certainly provides added value when it comes to understanding and helping your business: with manufacturing and quality control processes, clinical study processes, support processes related to premises, equipment and subcontractors, improvement processes (for example, risks, deviations and out-of-specification issues) as well as with creating and improving your own tailor-made QMS.
I am proud to be the chairman of salamanderU’s board of directors. salamanderU’s innovative products combined with a robust, creative and reliable QMS are your best guarantee for complying with all the regulatory requirements for your Market Authorization Application process.
We wrote a white paper to present a closer look at what Industry 4.0 entails for the pharma industry. We explain the potential benefits of adopting pharma 4.0 technologies as well as how to prevent common pitfalls.
If Industry 4.0 or smart industry technologies become a widespread phenomenon, it could help reduce operational costs and administrative burdens for manufacturers. Read our article on Industry 4.0 published in "Pharmaceutical Manufacturing and Packing Sourcer November 2019".