Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dos...Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.展开更多
Software Development Life Cycle (SDLC) is one of the major ingredients for the development of efficient software systems within a time frame and low-cost involvement. From the literature, it is evident that there are ...Software Development Life Cycle (SDLC) is one of the major ingredients for the development of efficient software systems within a time frame and low-cost involvement. From the literature, it is evident that there are various kinds of process models that are used by the software industries for the development of small, medium and long-term software projects, but many of them do not cover risk management. It is quite obvious that the improper selection of the software development process model leads to failure of the software products as it is time bound activity. In the present work, a new software development process model is proposed which covers the risks at any stage of the development of the software product. The model is named a Hemant-Vipin (HV) process model and may be helpful for the software industries for development of the efficient software products and timely delivery at the end of the client. The efficiency of the HV process model is observed by considering various kinds of factors like requirement clarity, user feedback, change agility, predictability, risk identification, practical implementation, customer satisfaction, incremental development, use of ready-made components, quick design, resource organization and many more and found through a case study that the presented approach covers many of parameters in comparison of the existing process models. .展开更多
文摘Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.
文摘Software Development Life Cycle (SDLC) is one of the major ingredients for the development of efficient software systems within a time frame and low-cost involvement. From the literature, it is evident that there are various kinds of process models that are used by the software industries for the development of small, medium and long-term software projects, but many of them do not cover risk management. It is quite obvious that the improper selection of the software development process model leads to failure of the software products as it is time bound activity. In the present work, a new software development process model is proposed which covers the risks at any stage of the development of the software product. The model is named a Hemant-Vipin (HV) process model and may be helpful for the software industries for development of the efficient software products and timely delivery at the end of the client. The efficiency of the HV process model is observed by considering various kinds of factors like requirement clarity, user feedback, change agility, predictability, risk identification, practical implementation, customer satisfaction, incremental development, use of ready-made components, quick design, resource organization and many more and found through a case study that the presented approach covers many of parameters in comparison of the existing process models. .
