process management
Our comprehensive support is aimed at optimizing your process management. We support you in identifying your quality-relevant processes and thus create the basis for focusing your validation efforts on the risky process steps, thus significantly reducing these efforts.
Who does what, when, how and with what?
Not only in medical technology, but also in the pharmaceutical industry, the topic of processes is becoming more and more central, since the revision of ISO 9001:2015, for example, has made formal processes a “must”, instead of an “option”. In addition, the Quality Risk Management as required not only by ICH Q9 is ideally based on processes that already design quality into the processes (“Quality by Design”).
Of course, process management has very different levels which, starting from the process map of the company, form the main processes with their management, core and support processes the basis for the actual business processes. Although these may primarily express the strategic orientation of the company, they can also be found at the lower level in an IT process or service map, which ultimately forms the basis of any IT infrastructure qualification (often mistakenly referred to as IT validation).
