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The introduction of quality, risk, safety, health and environmental management philosophies has significantly changed industry's view of company organization and controlling processes.
Although the concept of quality risk management has been well elucidated in the literature, the topic of KM has received relatively scant attention.
In the quality by design (QbD) paradigm, global regulatory agencies have introduced the concepts of quality risk management and knowledge management (KM) as enablers for an enhanced pharmaceutical quality system.
The need for a risk management ontology for a pharmaceutical environment is demonstrated, and the term "ontology" is generally defined and described with regard to the knowledge domain of quality risk management.
In this manner, by using our system, we were able to significantly improve real-time tracking and pre-warning of the risk state, automatic generation of quality risk publicity figures, efficiency, and risk management levels.
Product risk is analyzed in terms of quality risk (Ting et al. 2014).
Similar(54)
To examine the relationships between various components of nursing home staffing (total staffing levels and staff mix, staff turnover, and changes in staffing patterns) to an important measure of quality, risk-adjusted rates of pressure ulcer development.
Principles defined in ICH Q9 are intended to describe development and use of systematic processes for the assessment, control, communication, and review of quality risks, throughout a product's lifecycle (development, manufacturing, and distribution; 2, 3).
Details and characteristics of the 49 included articles can be found in Additional file 4. The assessment of study quality (risk of bias) for all included studies is presented in Table 2.
There were insufficient trials to conduct a sensitivity analysis to investigate the robustness of the results to the quality (risk of bias) components.
Study selection and quality risk of bias assessment were carried out independently.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com