This paper highlights the critical role of medical device design and development documents within the quality system,including their compliance with regulatory standards,their function as a traceable record,their supp...This paper highlights the critical role of medical device design and development documents within the quality system,including their compliance with regulatory standards,their function as a traceable record,their support for all stages,and their use in risk and change management.It also covers document template creation,review record association,information management,adverse event traceability,and the reconciliation of differences in international declarations.展开更多
Objective To ensure the quality and safety of drugs in the whole cycle of pharmaceutical commissioned production under the drug marketing authorization holder(MAH)system,and to establish a perfect quality management s...Objective To ensure the quality and safety of drugs in the whole cycle of pharmaceutical commissioned production under the drug marketing authorization holder(MAH)system,and to establish a perfect quality management system for it.Methods Literature review was used to study the factors that influenced the quality management system of pharmaceutical commissioned production because the implementation of MAH system in China was late,and the experience accumulated by pharmaceutical industry was not enough.Results and Conclusion Based on the MAH system,it is of great significance to establish the quality management system for pharmaceutical commissioned production.展开更多
Water quality system informatics(WQSI)is an emerging field that employs cybernetics to collect and digitize data associated with water quality.It involves monitoring the physical,chemical,and biological processes that...Water quality system informatics(WQSI)is an emerging field that employs cybernetics to collect and digitize data associated with water quality.It involves monitoring the physical,chemical,and biological processes that affect water quality and the ecological impacts and interconnections within water quality systems.WQSI integrates theories and methods from water quality engineering,information engineering,and system control theory,enabling the intelligent management and control of water quality.This integration revolutionizes the understanding and management of water quality systems with greater precision and higher resolution.WQSI is a new stage of development in environmental engineering that is driven by the digital age.This work explores the fundamental concepts,research topics,and methods of WQSI and its features and potential to promote disciplinary development.The innovation and development of WQSI are crucial for driving the digital and intelligent transformation of national industry patterns in China,positioning China at the forefront of environmental engineering and ecological environment research on a global scale.展开更多
The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and techno...The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and technology transfer. This requires the technology transfer process to be regulated as the part of pharmaceutical quality system and the following development of corresponding written procedures. The following publication is dedicated to the development of TTP （technology transfer process） and its accessible graphic formalisation alongside the definition of main stages and possible procedures limited by the offered model. According to the actualized GMP rules, the technology transfer is an essential part of pharmaceutical quality system at a modem pharmaceutical company.展开更多
This paper classifies the factors related with the quality system of the urbanization into three dimensions as quality planning, quality realization and quality improvement according to the relationship of their mutua...This paper classifies the factors related with the quality system of the urbanization into three dimensions as quality planning, quality realization and quality improvement according to the relationship of their mutual actions. Then it fabricates a three-dimension space structural model. In order to achieve sustainable improvement on urbanization quality improvement, this paper puts forward the measures of controlling the operation of the quality system of urbanization to make it run effectively and smoothly.展开更多
Afirst-class forwarding agent company approved by the Ministry of Foreign Trade and Economic Cooperation,the Ministry of Communication, the General Customs and the Civil Aviation Administration of China, the Shanghai ...Afirst-class forwarding agent company approved by the Ministry of Foreign Trade and Economic Cooperation,the Ministry of Communication, the General Customs and the Civil Aviation Administration of China, the Shanghai Jinhai Jieya International Forwarding Co. Ltd comprises the Shanghai Haigang Industrial General Company,Shanghai Jin Jiang Associated Corporation (Group) and Hongkong Jieya Air Freight Forwarding Corporation, in the form of a joint venture.展开更多
The disinfection supply room is a very important department of the hospital.Its main job is to provide sterile equipment and dressings for various activities in the hospital.It is an important department in the hospit...The disinfection supply room is a very important department of the hospital.Its main job is to provide sterile equipment and dressings for various activities in the hospital.It is an important department in the hospital infection management process.Doing a good job in the control and management of the disinfection supply room is the main link to ensure the prevention and control of hospital infections.The quality of management directly affects modern clinical medical work.Therefore,the hospital supply room should be strengthened and improved to ensure that all items can be safely used in the work process,which can effectively avoid the occurrence of cross-infection incidents in the hospital.展开更多
Compliance to the PIC/s GMP[1]standards is a mandatory and challenging requirement for ASEAN Pharmaceutical manufactures.PIC/s has at its foundation and as a very strong basis the need for a robust and wide ranging Qu...Compliance to the PIC/s GMP[1]standards is a mandatory and challenging requirement for ASEAN Pharmaceutical manufactures.PIC/s has at its foundation and as a very strong basis the need for a robust and wide ranging Quality Management System that will impact nearly all the departments in the organization and requires companies to setup detailed controls and records across all relevant quality aspects.To achieve the PIC/s quality objectives reliably and efficiently,a comprehensively designed and implemented QMS will be based on the Quality Assurance principles and will integrate GMP,Quality Control and Quality Risk Management.The key functions required in a QMS are Document Control,Training Management Quality Event Management Quality Risk Management(QRM),Supplier Management and Audit Management.By operating a paper QMS.展开更多
Success in the excavation of geological formations is commonly known as being very important in asserting stability. Furthermore, when the subjected geological formation is rocky and the use of explosives is required,...Success in the excavation of geological formations is commonly known as being very important in asserting stability. Furthermore, when the subjected geological formation is rocky and the use of explosives is required, the demands of successful blasting are multiplied. The present paper proposes a classification system, named： BQS （Blastability Quality System）, for rock masses with closely spaced discontinuities （spacing lower than 0.1 m）. It is obvious that rock quality is one of the main characteristics which define the blast ability of a rock. The BQS can be an easy and widely-used tool as it is a quick evaluator for blastability and rock mass quality at one time. Taking into consideration the research calculations and the parameters of BQS, what has been at question in this paper is the effect of blast ability in a geological formation with closely spaced discontinuities.展开更多
The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to it...The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.展开更多
In the context of the coordinated pursuit of"carbon peak and neutrality"objectives,alongside the strategy to establish a robust agricultural nation,the economic and social development of rural areas is under...In the context of the coordinated pursuit of"carbon peak and neutrality"objectives,alongside the strategy to establish a robust agricultural nation,the economic and social development of rural areas is undergoing a profound paradigm shift.The traditional rural division of labor pattern,which depends on tangible factors such as land,labor,and capital,has increasingly encountered developmental challenges characterized by diminishing marginal returns and a detrimental cycle of internal competition.The new quality productive force,centered on data,algorithms,green technologies,bioengineering,and clean energy,offers a potential pathway for the rural division of labor system to overcome the"low-level equilibrium".This force is characterized by attributes such as non-exclusivity,replicability,network collaboration,and ecological compatibility.This paper develops a three-dimensional collaborative analytical framework encompassing"technology,institution,and culture".It systematically elucidates the internal logic by which new quality productive forces drive the transformation of the rural division of labor from"quantitative factor matching"to"qualitative structural reorganization"through three principal mechanisms:technology embedding,institutional reconstruction,and cultural coupling.Furthermore,the study proposes corresponding policy recommendations,thereby offering theoretical insights to support the modernization of China s agriculture and rural areas,as well as the development of a strong agricultural country.展开更多
The composite material layering process has attracted considerable attention due to its production advantages,including high scalability and compatibility with a wide range of raw materials.However,changes in process ...The composite material layering process has attracted considerable attention due to its production advantages,including high scalability and compatibility with a wide range of raw materials.However,changes in process conditions can lead to degradation in layer quality and non-uniformity,highlighting the need for real-time monitoring to improve overall quality and efficiency.In this study,an AI-based monitoring system was developed to evaluate layer width and assess quality in real time.Three deep learning models Faster Region-based Convolutional Neural Network(R-CNN),You Only Look Once version 8(YOLOv8),and Single Shot MultiBox Detector(SSD)were compared,and YOLOv8 was ultimately selected for its superior speed,flexibility,and scalability.The selected model was integrated into a user-friendly interface.To verify the reliability of the system,bead width control experiments were conducted,which identified feed speed and extrusion speed as the key process parameters.Accordingly,a Central Composite Design(CCD)experimental plan with 13 conditions was applied to evaluate layer width and validate the system’s reliability.Finally,the proposed system was applied to the additive manufacturing of an aerospace component,where it successfully detected bead width deviations during printing and enabled stable fabrication with a maximum geometric deviation of approximately 6 mm.These findings demonstrate the critical role of real-time monitoring of layer width and quality in improving process stability and final product quality in composite material additive manufacturing.展开更多
Power quality is a crucial area of research in contemporary power systems,particularly given the rapid proliferation of intermittent renewable energy sources such as wind power.This study investigated the relationship...Power quality is a crucial area of research in contemporary power systems,particularly given the rapid proliferation of intermittent renewable energy sources such as wind power.This study investigated the relationships between power quality indices of system output and PSD by utilizing theories related to spectra,PSD,and random signal power spectra.The relationship was derived,validated through experiments and simulations,and subsequently applied to multi-objective optimization.Various optimization algorithms were compared to achieve optimal system power quality.The findings revealed that the relationships between power quality indices and PSD were influenced by variations in the order of the power spectral estimation model.An increase in the order of the AR model resulted in a 36%improvement in the number of optimal solutions.Regarding optimal solution distribution,NSGA-II demonstrated superior diversity,while MOEA/D exhibited better convergence.However,practical applications showed that while MOEA/D had higher convergence,NSGA-II produced superior optimal solutions,achieving the best power quality indices(THDi at 4.62%,d%at 3.51%,and cosφat 96%).These results suggest that the proposed method holds significant potential for optimizing power quality in practical applications.展开更多
BACKGROUND The coronavirus disease 2019(COVID-19)pandemic has had profound physical,psychological,and social consequences,with lasting effects on health-related quality of life(HRQoL)among people with a history of COV...BACKGROUND The coronavirus disease 2019(COVID-19)pandemic has had profound physical,psychological,and social consequences,with lasting effects on health-related quality of life(HRQoL)among people with a history of COVID-19.AIM To synthesize the current evidence on HRQoL and long-term health outcomes among people with a history of COVID-19 in India.METHODS We incorporated studies from India reporting post-COVID HRQoL outcomes using validated instruments,including the 5-level EuroQol 5-Dimensional questionnaire,the EuroQol Visual Analogue Scale,the Short Form-36 Health Survey,the World Health Organization Quality of Life-Brief Version,and the European Health Interview Survey-Quality of Life.Pooled mean 5-level EuroQol 5-Dimensional questionnaire scores with 95%CIs were calculated for HRQoL.Adjusted odds ratios were pooled for comorbidity,disease severity,intensive care unit admission,age,sex,and vaccination status using random-effects models.RESULTS Three studies(n=1526)reported EuroQol instruments,with the 5-level EuroQol 5-Dimensional questionnaire utility scores suitable for quantitative pooling.The pooled mean utility was 0.83(95%CI:0.75-0.92),although heterogeneity was high because the included studies represented clinically distinct populations.Across all studies,several determinants were consistently associated with impaired HRQoL.Older adults(≥60 years)had higher odds of poor HRQoL[pooled odds ratio(OR)=1.83,95%CI:1.43-2.35],and females were more likely to experience impaired HRQoL(pooled OR=1.74,95%CI:1.44-2.10),whereas males had a lower risk(pooled OR=0.58,95%CI:0.48-0.70).Being unvaccinated increased the likelihood of persistent symptoms or reduced HRQoL(pooled OR=1.60,95%CI:1.21-2.14).Comorbidity(pooled OR=1.94,95%CI:1.43-2.63)and severe acute COVID-19 or intensive care unit admission(pooled OR=2.77,95%CI:2.13-3.59)were also strongly associated with poorer HRQoL Six additional studies utilizing disparate instruments(EuroQol Visual Analogue Scale,Short Form-36 Health Survey,World Health Organization Quality of Life-Brief Version,European Health Interview Survey-Quality of Life)were excluded from quantitative synthesis due to measurement heterogeneity.CONCLUSION Post-COVID HRQoL in people with a history of COVID-19 in India is suboptimal,with greater impairment observed among older adults,females,patients with comorbidities or severe disease,and unvaccinated individuals.These findings highlight the need for targeted rehabilitation and preventive strategies.展开更多
BACKGROUND Colonoscopy quality relies heavily on adequate bowel preparation,yet traditional methods often result in suboptimal compliance.Emerging network-based monitoring systems offer promise for improving both prep...BACKGROUND Colonoscopy quality relies heavily on adequate bowel preparation,yet traditional methods often result in suboptimal compliance.Emerging network-based monitoring systems offer promise for improving both preparation quality and patient cooperation,potentially enhancing clinical outcomes.AIM To evaluate the effectiveness of an intestinal network monitoring system in enhancing the quality of bowel preparation for colonoscopy and its impact on patient psychological and physiological responses,compliance,and adverse event rates.METHODS Between July 2019 and July 2020,800 enteroscopy patients who met the inclusion criteria in the outpatient clinic of the gastroenterology department of our hospital were randomly divided into 400 cases each in the experimental group(network monitoring group)and the control group(verbal+written preaching group),and the psychological and physiological stress response situation,colon Boston Bowel Preparation Scale,enteroscopy to blindness,arrival time to blindness,and polyp detection rate of the patients were compared before and after the intervention,compliance and adverse reactions were compared.RESULTS There was no difference in anxiety and depression scores,heart rate and systolic blood pressure between the groups before the intervention(P>0.05),and after the intervention,the patients’anxiety and depression scores were lower and lower in the study group(P<0.05);heart rate and systolic blood pressure were elevated,but lower in the test group(P<0.05).The left hemicolon,right hemicolon,transverse colon and total Boston Bowel Preparation Scale scores were lower in the test group than in the control group(P<0.05),the colonoscopy arrival rate and polyp detection rate were higher than those in the control group,and the time to arrival and time to exit the scope were shorter than those in the control group(P<0.05),and the dietary preparations,the preparations for taking medications and the total adherence scores were higher than those in the control group(P<0.05).The incidence of adverse reactions in the experimental group was 11.00%,which was lower than that in the control group(P<0.05).CONCLUSION The Bowel Network Monitoring System has potential clinical promotion value in improving the quality of colonoscopic bowel preparation,which can effectively alleviate patient anxiety and depression,improve the quality of colonoscopic bowel preparation and patient compliance,and has a high degree of safety.展开更多
The productive evaluation of cocoa in this research is proposed through an assessment of soil quality and crop health in an organic production system(SPO)Taisha canton and a conventional production system(SPCv)Morona ...The productive evaluation of cocoa in this research is proposed through an assessment of soil quality and crop health in an organic production system(SPO)Taisha canton and a conventional production system(SPCv)Morona canton.Methodology:Altieri and Nicholls establish a diagnosis of chemical,physical,biological and health indicators,with weightings high(10),medium(5)and low(1).Results:SPO soil quality,reflects weights 10(high)for ammonium ion,zinc,copper,iron,manganese,moisture retention,biological activity,compaction,apparent density,residue status,color,organic matter,root development,erosion incidence,5(medium)potassium,phosphorus,calcium,sulfur,pH,texture,1(low)magnesium,boron,topsoil depth,for crop health values of 10(high)appearance,crop growth,stress resistance or tolerance,weed competition,agrosilvopastoral system,plant diversity and management system,5(medium)potential yield,incidence of pests and diseases.The SPCv soil quality presented a weighting of 10(high)for nitrogen,zinc,copper,iron,biological activity,compaction,bulk density,color,organic matter,root development,erosion incidence,5(medium)manganese,pH,texture,moisture retention,residue status,1(low)potassium,phosphorus,calcium,magnesium,sulfur,boron,topsoil depth,crop health 10(high)crop appearance and growth,stress resistance or tolerance,weed competition,agrosilvopastoral system,plant diversity,management system,potential yield,5(medium)incidence of pests and diseases,1(low)surrounding natural diversity.Conclusions:The SPO for soil quality:7.41 and for crop health:7.59 weighted as sustainable,while the SPCv for soil quality:6 and crop health:6.76,resulting in a moderately sustainable production system.展开更多
Hybrid teaching has become an essential direction of the teaching reform and innovation of higher education,and puts forward new requirements for the evaluation system of teaching quality.The background of hybrid teac...Hybrid teaching has become an essential direction of the teaching reform and innovation of higher education,and puts forward new requirements for the evaluation system of teaching quality.The background of hybrid teaching,the CIPP model,and teaching quality evaluation system,and the necessity of constructing a hybrid teaching quality evaluation system are further discussed.This paper also discusses the evaluation focus of the CIPP model and its applicability in the hybrid teaching quality evaluation and believes that the CIPP model can reflect the concept innovation,target diversity,process advancement,and subject participation;the evaluation indicator system of hybrid teaching quality is designed based on the CIPP model,which provides a reference for the hybrid teaching quality evaluation and teaching reform.展开更多
Objectives:This study aimed to evaluate the measurement properties and methodological quality of instruments developed to evaluate the quality of online health information.Methods:In this study,a systematic search was...Objectives:This study aimed to evaluate the measurement properties and methodological quality of instruments developed to evaluate the quality of online health information.Methods:In this study,a systematic search was conducted across a range of databases,including the China National Knowledge Infrastructure(CNKI),Wanfang,China Science and Technology Journal(VIP),SinoMed,PubMed,Web of Science,CINAHL,Embase,the Cochrane Library,PsycINFO,and Scopus.The search period spanned from the inception of the databases to October 2023.Two researchers independently conducted the literature screening and data extraction.The methodological quality of the included studies was assessed using the Consensus-based Standards for the Selection of Health Measurement Instruments(COSMIN)Risk of Bias checklist.The measurement properties were evaluated using the coSMIN criteria.The modified Grading,Recommendations,Assessment,Development,and Evaluation(GRADE)system was used to determine the quality grade.Results:A total of 18 studies were included,and the measurement properties of 17 scales were assessed.Fifteen scales had content validity,three had structural validity,six had internal consistency,two had test-retest reliability,nine had interater reliability,one had measurement error,six instruments had criterion validity,and three scales had hypotheses testing for construct validity;however,the evaluation of their methodological quality and measurement properties revealed deficiencies.Of these 17 scales,15 were assigned a Level B recommendation,and two received a Level C recommendation.Conclusions:The Health Information Website Evaluation Tool(HIWET)can be temporarily used to evaluate the quality of health information on websites.The Patient Education Materials Assessment Tool(PEMAT)can temporarily assess the quality of video-based health information.However,the effectiveness of both tools needs to be further verified.展开更多
Radiomics and machine learning(ML)are increasingly utilized to predict treatment response by uncovering latent information in medical images.This study systematically reviews radiomics studies on brain metastasis trea...Radiomics and machine learning(ML)are increasingly utilized to predict treatment response by uncovering latent information in medical images.This study systematically reviews radiomics studies on brain metastasis treated with stereotactic radio-surgery(SRS)and quantifies their radiomic quality score(RQS).A systematic search on Scopus,Web of Science,and PubMed was conducted to identify original studies on radiomics for predicting treatment response,adhering to predefined patient,intervention,comparator,and outcome(PICO)criteria.No restrictions were placed on language or publication date.Two in-dependent reviewers assessed eligible studies,and the RQS was calculated based on Lambin’s guidelines.The Preferred Reporting Items for Systematic Review and Meta-Analysis(PRISMA)2020 guidelines were followed.Seventeen studies involving 2744 patients met the inclusion criteria out of 200 identified.All studies were retrospective and utilizing various MRI scanners models with different field strength.The average RQS across studies was low(39.2%),with a maximum score of 19 points(52.7%).Radiomic-based models demonstrated superior predictive accuracy compared to clinical or visual assessment,with AUC values ranging from 0.74 to 0.92.Integration of clinical features such as Karnofsky performance status,dose,and isodose line further improved model performance.Deep learning models achieved the highest predictive accuracy,with AUC of 0.92.Radiomics demonstrate significant potential in predicting treatment outcomes with high accuracy,offering opportunities to advance personalized management for BM.To facilitate clinical adoption,future studies must prioritize adherence to standardized guidelines and robust model validation to ensure reproducibility.展开更多
文摘This paper highlights the critical role of medical device design and development documents within the quality system,including their compliance with regulatory standards,their function as a traceable record,their support for all stages,and their use in risk and change management.It also covers document template creation,review record association,information management,adverse event traceability,and the reconciliation of differences in international declarations.
文摘Objective To ensure the quality and safety of drugs in the whole cycle of pharmaceutical commissioned production under the drug marketing authorization holder(MAH)system,and to establish a perfect quality management system for it.Methods Literature review was used to study the factors that influenced the quality management system of pharmaceutical commissioned production because the implementation of MAH system in China was late,and the experience accumulated by pharmaceutical industry was not enough.Results and Conclusion Based on the MAH system,it is of great significance to establish the quality management system for pharmaceutical commissioned production.
基金the support provided by the National Natural Science Foundation of China(52327813,52131003,and 52370058)the Outstanding Scientist of Chongqing Talent Plan(CQYC20210101288 and CQYC202101006)。
文摘Water quality system informatics(WQSI)is an emerging field that employs cybernetics to collect and digitize data associated with water quality.It involves monitoring the physical,chemical,and biological processes that affect water quality and the ecological impacts and interconnections within water quality systems.WQSI integrates theories and methods from water quality engineering,information engineering,and system control theory,enabling the intelligent management and control of water quality.This integration revolutionizes the understanding and management of water quality systems with greater precision and higher resolution.WQSI is a new stage of development in environmental engineering that is driven by the digital age.This work explores the fundamental concepts,research topics,and methods of WQSI and its features and potential to promote disciplinary development.The innovation and development of WQSI are crucial for driving the digital and intelligent transformation of national industry patterns in China,positioning China at the forefront of environmental engineering and ecological environment research on a global scale.
文摘The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and technology transfer. This requires the technology transfer process to be regulated as the part of pharmaceutical quality system and the following development of corresponding written procedures. The following publication is dedicated to the development of TTP （technology transfer process） and its accessible graphic formalisation alongside the definition of main stages and possible procedures limited by the offered model. According to the actualized GMP rules, the technology transfer is an essential part of pharmaceutical quality system at a modem pharmaceutical company.
文摘This paper classifies the factors related with the quality system of the urbanization into three dimensions as quality planning, quality realization and quality improvement according to the relationship of their mutual actions. Then it fabricates a three-dimension space structural model. In order to achieve sustainable improvement on urbanization quality improvement, this paper puts forward the measures of controlling the operation of the quality system of urbanization to make it run effectively and smoothly.
文摘Afirst-class forwarding agent company approved by the Ministry of Foreign Trade and Economic Cooperation,the Ministry of Communication, the General Customs and the Civil Aviation Administration of China, the Shanghai Jinhai Jieya International Forwarding Co. Ltd comprises the Shanghai Haigang Industrial General Company,Shanghai Jin Jiang Associated Corporation (Group) and Hongkong Jieya Air Freight Forwarding Corporation, in the form of a joint venture.
文摘The disinfection supply room is a very important department of the hospital.Its main job is to provide sterile equipment and dressings for various activities in the hospital.It is an important department in the hospital infection management process.Doing a good job in the control and management of the disinfection supply room is the main link to ensure the prevention and control of hospital infections.The quality of management directly affects modern clinical medical work.Therefore,the hospital supply room should be strengthened and improved to ensure that all items can be safely used in the work process,which can effectively avoid the occurrence of cross-infection incidents in the hospital.
文摘Compliance to the PIC/s GMP[1]standards is a mandatory and challenging requirement for ASEAN Pharmaceutical manufactures.PIC/s has at its foundation and as a very strong basis the need for a robust and wide ranging Quality Management System that will impact nearly all the departments in the organization and requires companies to setup detailed controls and records across all relevant quality aspects.To achieve the PIC/s quality objectives reliably and efficiently,a comprehensively designed and implemented QMS will be based on the Quality Assurance principles and will integrate GMP,Quality Control and Quality Risk Management.The key functions required in a QMS are Document Control,Training Management Quality Event Management Quality Risk Management(QRM),Supplier Management and Audit Management.By operating a paper QMS.
文摘Success in the excavation of geological formations is commonly known as being very important in asserting stability. Furthermore, when the subjected geological formation is rocky and the use of explosives is required, the demands of successful blasting are multiplied. The present paper proposes a classification system, named： BQS （Blastability Quality System）, for rock masses with closely spaced discontinuities （spacing lower than 0.1 m）. It is obvious that rock quality is one of the main characteristics which define the blast ability of a rock. The BQS can be an easy and widely-used tool as it is a quick evaluator for blastability and rock mass quality at one time. Taking into consideration the research calculations and the parameters of BQS, what has been at question in this paper is the effect of blast ability in a geological formation with closely spaced discontinuities.
文摘The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.
基金Supported by Key Project of Jiangsu Education Science Planning"Research on the Structural Adjustment of Higher Education in Jiangsu in the Context of High-Quality Economic Development"(B/2021/01/67).
文摘In the context of the coordinated pursuit of"carbon peak and neutrality"objectives,alongside the strategy to establish a robust agricultural nation,the economic and social development of rural areas is undergoing a profound paradigm shift.The traditional rural division of labor pattern,which depends on tangible factors such as land,labor,and capital,has increasingly encountered developmental challenges characterized by diminishing marginal returns and a detrimental cycle of internal competition.The new quality productive force,centered on data,algorithms,green technologies,bioengineering,and clean energy,offers a potential pathway for the rural division of labor system to overcome the"low-level equilibrium".This force is characterized by attributes such as non-exclusivity,replicability,network collaboration,and ecological compatibility.This paper develops a three-dimensional collaborative analytical framework encompassing"technology,institution,and culture".It systematically elucidates the internal logic by which new quality productive forces drive the transformation of the rural division of labor from"quantitative factor matching"to"qualitative structural reorganization"through three principal mechanisms:technology embedding,institutional reconstruction,and cultural coupling.Furthermore,the study proposes corresponding policy recommendations,thereby offering theoretical insights to support the modernization of China s agriculture and rural areas,as well as the development of a strong agricultural country.
基金support of the Korea Institute of Industrial Technol-ogy as“Development of a remote manufacturing system for high-risk,high-difficulty pipe production processes”(kitech EH-25-0004)supported by the Technology Innovation Program(or Industrial Strategic Technology Development Program)(RS-2023–00237714+2 种基金Development of Dynamic Metrology Tool for CMP Process StabilizationRS-2025–02634755Development of Real-Time Electrical Fire Prevention System Technology Reflecting the Characteristics of Traditional Markets)funded by the Ministry of Trade,Industry&Energy(MOTIE,Republic of Korea).
文摘The composite material layering process has attracted considerable attention due to its production advantages,including high scalability and compatibility with a wide range of raw materials.However,changes in process conditions can lead to degradation in layer quality and non-uniformity,highlighting the need for real-time monitoring to improve overall quality and efficiency.In this study,an AI-based monitoring system was developed to evaluate layer width and assess quality in real time.Three deep learning models Faster Region-based Convolutional Neural Network(R-CNN),You Only Look Once version 8(YOLOv8),and Single Shot MultiBox Detector(SSD)were compared,and YOLOv8 was ultimately selected for its superior speed,flexibility,and scalability.The selected model was integrated into a user-friendly interface.To verify the reliability of the system,bead width control experiments were conducted,which identified feed speed and extrusion speed as the key process parameters.Accordingly,a Central Composite Design(CCD)experimental plan with 13 conditions was applied to evaluate layer width and validate the system’s reliability.Finally,the proposed system was applied to the additive manufacturing of an aerospace component,where it successfully detected bead width deviations during printing and enabled stable fabrication with a maximum geometric deviation of approximately 6 mm.These findings demonstrate the critical role of real-time monitoring of layer width and quality in improving process stability and final product quality in composite material additive manufacturing.
基金funded by the Inner Mongolia Nature Foundation Project,Project number:2023JQ04.
文摘Power quality is a crucial area of research in contemporary power systems,particularly given the rapid proliferation of intermittent renewable energy sources such as wind power.This study investigated the relationships between power quality indices of system output and PSD by utilizing theories related to spectra,PSD,and random signal power spectra.The relationship was derived,validated through experiments and simulations,and subsequently applied to multi-objective optimization.Various optimization algorithms were compared to achieve optimal system power quality.The findings revealed that the relationships between power quality indices and PSD were influenced by variations in the order of the power spectral estimation model.An increase in the order of the AR model resulted in a 36%improvement in the number of optimal solutions.Regarding optimal solution distribution,NSGA-II demonstrated superior diversity,while MOEA/D exhibited better convergence.However,practical applications showed that while MOEA/D had higher convergence,NSGA-II produced superior optimal solutions,achieving the best power quality indices(THDi at 4.62%,d%at 3.51%,and cosφat 96%).These results suggest that the proposed method holds significant potential for optimizing power quality in practical applications.
文摘BACKGROUND The coronavirus disease 2019(COVID-19)pandemic has had profound physical,psychological,and social consequences,with lasting effects on health-related quality of life(HRQoL)among people with a history of COVID-19.AIM To synthesize the current evidence on HRQoL and long-term health outcomes among people with a history of COVID-19 in India.METHODS We incorporated studies from India reporting post-COVID HRQoL outcomes using validated instruments,including the 5-level EuroQol 5-Dimensional questionnaire,the EuroQol Visual Analogue Scale,the Short Form-36 Health Survey,the World Health Organization Quality of Life-Brief Version,and the European Health Interview Survey-Quality of Life.Pooled mean 5-level EuroQol 5-Dimensional questionnaire scores with 95%CIs were calculated for HRQoL.Adjusted odds ratios were pooled for comorbidity,disease severity,intensive care unit admission,age,sex,and vaccination status using random-effects models.RESULTS Three studies(n=1526)reported EuroQol instruments,with the 5-level EuroQol 5-Dimensional questionnaire utility scores suitable for quantitative pooling.The pooled mean utility was 0.83(95%CI:0.75-0.92),although heterogeneity was high because the included studies represented clinically distinct populations.Across all studies,several determinants were consistently associated with impaired HRQoL.Older adults(≥60 years)had higher odds of poor HRQoL[pooled odds ratio(OR)=1.83,95%CI:1.43-2.35],and females were more likely to experience impaired HRQoL(pooled OR=1.74,95%CI:1.44-2.10),whereas males had a lower risk(pooled OR=0.58,95%CI:0.48-0.70).Being unvaccinated increased the likelihood of persistent symptoms or reduced HRQoL(pooled OR=1.60,95%CI:1.21-2.14).Comorbidity(pooled OR=1.94,95%CI:1.43-2.63)and severe acute COVID-19 or intensive care unit admission(pooled OR=2.77,95%CI:2.13-3.59)were also strongly associated with poorer HRQoL Six additional studies utilizing disparate instruments(EuroQol Visual Analogue Scale,Short Form-36 Health Survey,World Health Organization Quality of Life-Brief Version,European Health Interview Survey-Quality of Life)were excluded from quantitative synthesis due to measurement heterogeneity.CONCLUSION Post-COVID HRQoL in people with a history of COVID-19 in India is suboptimal,with greater impairment observed among older adults,females,patients with comorbidities or severe disease,and unvaccinated individuals.These findings highlight the need for targeted rehabilitation and preventive strategies.
基金Supported by the Changshu Municipal Health Commission Science and Technology Program,No.csws201902。
文摘BACKGROUND Colonoscopy quality relies heavily on adequate bowel preparation,yet traditional methods often result in suboptimal compliance.Emerging network-based monitoring systems offer promise for improving both preparation quality and patient cooperation,potentially enhancing clinical outcomes.AIM To evaluate the effectiveness of an intestinal network monitoring system in enhancing the quality of bowel preparation for colonoscopy and its impact on patient psychological and physiological responses,compliance,and adverse event rates.METHODS Between July 2019 and July 2020,800 enteroscopy patients who met the inclusion criteria in the outpatient clinic of the gastroenterology department of our hospital were randomly divided into 400 cases each in the experimental group(network monitoring group)and the control group(verbal+written preaching group),and the psychological and physiological stress response situation,colon Boston Bowel Preparation Scale,enteroscopy to blindness,arrival time to blindness,and polyp detection rate of the patients were compared before and after the intervention,compliance and adverse reactions were compared.RESULTS There was no difference in anxiety and depression scores,heart rate and systolic blood pressure between the groups before the intervention(P>0.05),and after the intervention,the patients’anxiety and depression scores were lower and lower in the study group(P<0.05);heart rate and systolic blood pressure were elevated,but lower in the test group(P<0.05).The left hemicolon,right hemicolon,transverse colon and total Boston Bowel Preparation Scale scores were lower in the test group than in the control group(P<0.05),the colonoscopy arrival rate and polyp detection rate were higher than those in the control group,and the time to arrival and time to exit the scope were shorter than those in the control group(P<0.05),and the dietary preparations,the preparations for taking medications and the total adherence scores were higher than those in the control group(P<0.05).The incidence of adverse reactions in the experimental group was 11.00%,which was lower than that in the control group(P<0.05).CONCLUSION The Bowel Network Monitoring System has potential clinical promotion value in improving the quality of colonoscopic bowel preparation,which can effectively alleviate patient anxiety and depression,improve the quality of colonoscopic bowel preparation and patient compliance,and has a high degree of safety.
文摘The productive evaluation of cocoa in this research is proposed through an assessment of soil quality and crop health in an organic production system(SPO)Taisha canton and a conventional production system(SPCv)Morona canton.Methodology:Altieri and Nicholls establish a diagnosis of chemical,physical,biological and health indicators,with weightings high(10),medium(5)and low(1).Results:SPO soil quality,reflects weights 10(high)for ammonium ion,zinc,copper,iron,manganese,moisture retention,biological activity,compaction,apparent density,residue status,color,organic matter,root development,erosion incidence,5(medium)potassium,phosphorus,calcium,sulfur,pH,texture,1(low)magnesium,boron,topsoil depth,for crop health values of 10(high)appearance,crop growth,stress resistance or tolerance,weed competition,agrosilvopastoral system,plant diversity and management system,5(medium)potential yield,incidence of pests and diseases.The SPCv soil quality presented a weighting of 10(high)for nitrogen,zinc,copper,iron,biological activity,compaction,bulk density,color,organic matter,root development,erosion incidence,5(medium)manganese,pH,texture,moisture retention,residue status,1(low)potassium,phosphorus,calcium,magnesium,sulfur,boron,topsoil depth,crop health 10(high)crop appearance and growth,stress resistance or tolerance,weed competition,agrosilvopastoral system,plant diversity,management system,potential yield,5(medium)incidence of pests and diseases,1(low)surrounding natural diversity.Conclusions:The SPO for soil quality:7.41 and for crop health:7.59 weighted as sustainable,while the SPCv for soil quality:6 and crop health:6.76,resulting in a moderately sustainable production system.
基金The 2025 Beijing Postdoctoral Research Activity Funding Project“Exploring Hybrid Teaching Quality Evaluation System Based on the CIPP Model Construction in Higher Education”(2025114)。
文摘Hybrid teaching has become an essential direction of the teaching reform and innovation of higher education,and puts forward new requirements for the evaluation system of teaching quality.The background of hybrid teaching,the CIPP model,and teaching quality evaluation system,and the necessity of constructing a hybrid teaching quality evaluation system are further discussed.This paper also discusses the evaluation focus of the CIPP model and its applicability in the hybrid teaching quality evaluation and believes that the CIPP model can reflect the concept innovation,target diversity,process advancement,and subject participation;the evaluation indicator system of hybrid teaching quality is designed based on the CIPP model,which provides a reference for the hybrid teaching quality evaluation and teaching reform.
基金supported by President Foundation of the Third Affiliated Hospital of Southern Medical University(YH202207)。
文摘Objectives:This study aimed to evaluate the measurement properties and methodological quality of instruments developed to evaluate the quality of online health information.Methods:In this study,a systematic search was conducted across a range of databases,including the China National Knowledge Infrastructure(CNKI),Wanfang,China Science and Technology Journal(VIP),SinoMed,PubMed,Web of Science,CINAHL,Embase,the Cochrane Library,PsycINFO,and Scopus.The search period spanned from the inception of the databases to October 2023.Two researchers independently conducted the literature screening and data extraction.The methodological quality of the included studies was assessed using the Consensus-based Standards for the Selection of Health Measurement Instruments(COSMIN)Risk of Bias checklist.The measurement properties were evaluated using the coSMIN criteria.The modified Grading,Recommendations,Assessment,Development,and Evaluation(GRADE)system was used to determine the quality grade.Results:A total of 18 studies were included,and the measurement properties of 17 scales were assessed.Fifteen scales had content validity,three had structural validity,six had internal consistency,two had test-retest reliability,nine had interater reliability,one had measurement error,six instruments had criterion validity,and three scales had hypotheses testing for construct validity;however,the evaluation of their methodological quality and measurement properties revealed deficiencies.Of these 17 scales,15 were assigned a Level B recommendation,and two received a Level C recommendation.Conclusions:The Health Information Website Evaluation Tool(HIWET)can be temporarily used to evaluate the quality of health information on websites.The Patient Education Materials Assessment Tool(PEMAT)can temporarily assess the quality of video-based health information.However,the effectiveness of both tools needs to be further verified.
文摘Radiomics and machine learning(ML)are increasingly utilized to predict treatment response by uncovering latent information in medical images.This study systematically reviews radiomics studies on brain metastasis treated with stereotactic radio-surgery(SRS)and quantifies their radiomic quality score(RQS).A systematic search on Scopus,Web of Science,and PubMed was conducted to identify original studies on radiomics for predicting treatment response,adhering to predefined patient,intervention,comparator,and outcome(PICO)criteria.No restrictions were placed on language or publication date.Two in-dependent reviewers assessed eligible studies,and the RQS was calculated based on Lambin’s guidelines.The Preferred Reporting Items for Systematic Review and Meta-Analysis(PRISMA)2020 guidelines were followed.Seventeen studies involving 2744 patients met the inclusion criteria out of 200 identified.All studies were retrospective and utilizing various MRI scanners models with different field strength.The average RQS across studies was low(39.2%),with a maximum score of 19 points(52.7%).Radiomic-based models demonstrated superior predictive accuracy compared to clinical or visual assessment,with AUC values ranging from 0.74 to 0.92.Integration of clinical features such as Karnofsky performance status,dose,and isodose line further improved model performance.Deep learning models achieved the highest predictive accuracy,with AUC of 0.92.Radiomics demonstrate significant potential in predicting treatment outcomes with high accuracy,offering opportunities to advance personalized management for BM.To facilitate clinical adoption,future studies must prioritize adherence to standardized guidelines and robust model validation to ensure reproducibility.
