The new "theory of growth" considers the innovation as a process which contributes to drive the economical development. The constraints of the market (regulation, laws, total quality, procedures, traceability as examples) are day after day more and more stringent and costly to implement in a very short time.
The industrial partners of the Life science Industry have to be able to provide innovations which cover what the drugs manufacturers cannot do by themselves simply because they have to focus on their core competencies : producing new molecules.
The expectations from this highly regulated market are based on creating value. A real innovation has to create value in different possible types :
implementation of the new and / or latest technology
the methodology has to include the specific environmental conditions as well as the universal guidelines (e.g. : GAMP)
financial issues to be included : quick response time and time to market brings quite a lot of advance and saves big amounts of money. Innovative solutions must be safer
full traceability and paperless trend to be considered as a central issue : less papers for more evidences
predictive features and proactive tasks and functions dramatically help for a better productivity
diagnostics functions for the critical process measuring points are values which the technology provide
the fieldbuses and digital networks connected to Bus Monitoring Systems and qualified & compliant tools highly ( independent from control systems ) is not only an idea. Costs and time reductions are the result of this advanced solution
the analysis of the process, when done with a partner having knowledge on conformity concerns and requirements creates one another kind of value : this partnership mentality raises the bar and creates the famous win-win situation
vendor's support has to include: participation to the URS in GxP's (Good Practices) conditions. Our experience is that Team working is a key which brings the success
regulatory impacts of the innovations to be of paramount importance. Process Analytical Technology to be mentioned as a major concern for the pharmaceutical processes
electronic plateform for management tasks (Computer System Calibration), lifecycle and traceability of the data (commercial and technical) must be achieved
The comprehension of the needs of the drugs manufacturing units, the risk assessment, the relationship, the shared decision making, the reliability of the deliverables, the expertise and the global fit create the best possible trust atmosphere.
