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).
At the level of business processes or individual activities, the processes form the basis for advisory documents such as SOPs, for employee training, for automation such as process automation through system selection, and so forth. The decisive factors here are often the data flow and the clear definition of interfaces, organizational and technical (SIPOC, Turtle diagram, Swimlane, process diagrams), as well as the clear specification of roles and responsibilities.
An auditor will always approach an audit from the perspective of the process because only a documented process can be lived and thus ensure GxP conformity.
- Process inventory, analysis and documentation (with integration of basic requirements and risk mitigation)
- Carrying out process audits, e.g. for special processes in the clinical setting
- Development and optimization of process validation for e.g. medical devices
- Development of process management systems for IT, e.g. in the context of IT validation
- Establishing processes in the GCP environment
- Introduction and optimization of quality management processes such as CAPA Management, Document Management, Change Management, Risk Management
- Development of a quality management manual