• 제목/요약/키워드: Compliance monitoring

검색결과 144건 처리시간 0.026초

인공호흡기 원격 통합 모니터링 및 제어 시스템 개발을 위한 소프트웨어 위험관리 및 사이버보안 (Software Risk Management and Cyber Security for Development of Integrated System Remotely Monitoring and Controlling Ventilators)

  • 정지용;김유림;장원석
    • 대한의용생체공학회:의공학회지
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    • 제44권2호
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    • pp.99-108
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    • 2023
  • According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

Industry's Response to the Green Movement

  • Little, Barry F.P.
    • 분석과학
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    • 제8권4호
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    • pp.1075-1078
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    • 1995
  • This paper describes how industry has responded to the environmental challenge. Benefits include compliance with environmental legislation; genuine reductions to environmental impact; sustainable improvements to profitability in the face of increased competitive pressure. National and international Standards for environmental management offer security and direction for a company wishing to improve environmental performance and coupled with a waste minimisation strategy many financial and environmental benefits can be achieved. Introduction of new technical skills, techniques and worker understanding to aid motivation is an essential component of such a strategy. Monitoring and targeting has a key role to play in the establishment of improved environmental performance.

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HVAC 파라미터 모니터링 시스템에 대한 고찰 (Computer Validation 중심으로) (A Study on HVAC Parameter Monitoring System (Regarding Computer Validation))

  • 김종구
    • 대한설비공학회:학술대회논문집
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    • 대한설비공학회 2008년도 하계학술발표대회 논문집
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    • pp.90-95
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    • 2008
  • This article presents practical advice regarding the implementation and management of an impeccable Building Management System. The BMS was introduced to the series of computerized systems including manufacturing, storage, distribution, and quality control. Recently revised GMP regulation is requesting an improvement in drug product quality regulatory system by computer system validation. Quality is critical to guarantee the efficacy and the safety of drugs and is approved in the evaluation process after the audit trail application. HVAC parameter monitoring system will record the identity of operators entering or confirming critical data. Authority to amend entered data should be restricted to nominated persons. Any alteration to an entry of critical data should be authorized in advance and recorded with the reason for the change.

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The effects of work environment monitoring organization's analysts' equipment and chemical substance incident response to the safety management awareness

  • Park, Hyun-A;Choi, Seo-Yeon;Rie, Dong-Ho
    • 한국컴퓨터정보학회논문지
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    • 제22권5호
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    • pp.97-103
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    • 2017
  • In this paper, we propose a method to investigate the safety consciousness of a analyst incident response. This study conducted a statistical survey on 154 analysts who hired as expert in environment monitoring organizations in South Korea. The results of the analyses showed that respondents had good awareness on the equipment incident response and complied with laboratory safety regulations very well. Secondly, respondents were aware of the importance in the order of equipment incident response, an analytical laboratory incident response, and the cause of a chemical substance associated incident in an analytical laboratory in regarding the regulation compliance for creating a safe laboratory environment and the securement of laboratory safety. Therefore, (it was identified that) it would be necessary to create a safe environment and integrate a safety management system.

A MODEL FOR SELECTION, AWARDING, AND MONITORING OF PPP PROJECTS IN DEVELOPING COUNTRIES; HEALTH CARE FACILITIES IN COLOMBIA

  • Henry Arboleda-Mantilla;Carlos A. Arboleda
    • 국제학술발표논문집
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    • The 5th International Conference on Construction Engineering and Project Management
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    • pp.344-351
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    • 2013
  • Private participation on public infrastructures projects is being promoted by governments of several developing countries, among them Colombia. As a result, several advantages such as service delivery efficiency, technology application and faster execution of the projects have been recognized. Hence, the Colombian Government is looking for schemes that allow the private investment in projects like hospitals, schools, prisons and public edification. In this paper, experiences in PPP from other countries were analyzed and adjusted to the Colombian environment. As a result, a model adapted to Colombia is presented, based on a well-developed case from Spain. The awarding process is defined by economic criteria, previous compliance of minimum technical exigencies. Once the infrastructure is operating, contractual periodical payments will be done, based on the performance of the facility.

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Monitoring of Red Pepper Powder and Seasoned Red-Pepper Sauce using Species-Specific PCR in Conjunction with Whole Genome Amplification

  • Hong, Yewon;Kwon, Kisung;Kang, Tae Sun
    • 한국식품위생안전성학회지
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    • 제33권2호
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    • pp.146-150
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    • 2018
  • 고추는 한국에서 매우 중요한 양념 중 하나이다. 하지만 수입 고춧가루와 다진 양념(다대기)에 부과되는 관세율(45%/270%)의 차이로 인해, 다진 양념이 수입된 후, 건조 및 분쇄 과정을 거쳐 고춧가루로 제작되고 있는 실정이다. 본 연구에서는 종 특이 PCR 기술과 whole-genome amplification 방법을 접목하여 고춧가루(N=45) 및 다진 양념(N=5) 제품의 사용원료(고추, 마늘, 양파, 파, 생강)를 분석하였다. 모니터링 결과, 39개 고춧가루 제품은 표시사항을 준수하였으며, 6개 고춧가루 및 5개 다진 양념 제품은 제조 기준을 충족시키지 못했다. 따라서 분석 제품의 22%가 표시사항을 준수하지 못한 것으로 밝혀졌으며, 본 연구에 사용한 분석 방법은 고춧가루 제품에 사용된 원료분석에 적합한 방법임을 입증하였다.

당뇨병환자의 지속적 자가 혈당관리에 따른 혈당조절의 효과 (Effects on Glycemic Control by Continuous Self Monitoring of Blood Glucose in Diabetic Patients)

  • 장경화;권명순
    • 가정간호학회지
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    • 제17권2호
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    • pp.104-111
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    • 2010
  • Purpose: To evaluate the effects of continuous self monitoring of blood glucose (SMBG) on glycemic control in diabetic patients. Methods: Among the diabetic patients who visited the department of internal medicine in H hospital from April 1 to October 27 2008, 76 patients were divided into the experimental group (n=39) and control group (n=36). The experimental group was required to measure blood glucose levels at least twice every other day using SMBG; their compliance was aided by weekly telephone reminders for 3 months after discharge. Glycated hemoglobin, fasting blood sugar and postprandial 2 hours glucose level, triglyceride and high density lipoprotein were measured before and after the study. Results: Baseline characteristics were not different between the experimental and control groups. Three months later, there was a significant difference in postprandial glucose between the two groups (t=-2.042, p=.045). Conclusion: There was significant improvement of glycemic control after the use of continuous SMBG, suggesting its value in strict glycemic control and the merit of an aggressive education program.

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A Case-Study of Implementation of Improved Strategies for Prevention of Laboratory-acquired Brucellosis

  • Castrodale, Louisa J.;Raczniak, Gregory A.;Rudolph, Karen M.;Chikoyak, Lori;Cox, Russell S.;Franklin, Tricia L.;Traxler, Rita M.;Guerra, Marta
    • Safety and Health at Work
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    • 제6권4호
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    • pp.353-356
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    • 2015
  • Background: In 2012, the Alaska Section of Epidemiology investigated personnel potentially exposed to a Brucella suis isolate as it transited through three laboratories. Methods: We summarize the first implementation of the United States Centers for Disease Control and Prevention 2013 revised recommendations for monitoring such exposures: (1) risk classification; (2) antimicrobial postexposure prophylaxis; (3) serologic monitoring; and (4) symptom surveillance. Results: Over 30 people were assessed for exposure and subsequently monitored for development of illness. No cases of laboratory-associated brucellosis occurred. Changes were made to gaps in laboratory biosafety practices that had been identified in the investigation. Conclusion: Achieving full compliance for the precise schedule of serologic monitoring was challenging and resource intensive for the laboratory performing testing. More refined exposure assessments could inform decision making for follow-up to maximize likelihood of detecting persons at risk while not overtaxing resources.

스마트시티 에너지 감시를 위한 CIM(Common Information Model) 프로파일 설계 (Design of CIM(Common Information Model) Profile for Smart City Energy Monitoring)

  • 김영일;채창훈;김예리;이지훈
    • KEPCO Journal on Electric Power and Energy
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    • 제8권2호
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    • pp.127-135
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    • 2022
  • With the advent of high technologies such as the 4th Industrial Revolution and artificial intelligence and big data, efforts are being made to solve urban problems and improve the quality of life by applying new technologies in the smart city field. In addition, as carbon neutrality has emerged as an important issue due to global warming, smart city energy platform technologies such as urban energy management, efficiency improvement, and carbon reduction are in the spotlight. In order to effectively manage urban energy, energy resource information such as electricity, water, gas, hot water, heating, etc. must be collected from the management system of various energy utilities and managed on the central platform. The centrally integrated data is delivered to external city management systems that require city energy information through an energy platform. This study developed a CIM profile for smart city energy monitoring required to provide energy data to external systems. Electric data model were designed using the CIM class of IEC 61970, and water, gas, and heat data model were designed in compliance with the UML-based design ideas of IEC 61970.

건축물 해체공사 안전 모니터링을 위한 3차원 자동변위계측 시스템 활용 방안 연구 (A Study on Applying 3D Automatic Displacement Measurement System for Safety Monitoring of Building Demolition Works)

  • 박한빈;한혜림;김태훈;조규만;조창근;김형기
    • 한국건축시공학회:학술대회논문집
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    • 한국건축시공학회 2022년도 가을 학술논문 발표대회
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    • pp.229-230
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    • 2022
  • According to the national building status, there are a total of 2.89 million buildings that are over 30 years old after completion, and the number is increasing by more than 70,000 to 80,000 buildings every year. As a result, the demand for demolition works is also increasing, and more than 3 to 4 collapse accidents occur steadily every year during demolition work. Major causes of accidents include non-compliance with plans, negligence of on-site supervisors, and failure to secure structural safety. Due to the strengthening of the Severe Disaster Punishment Act, there is growing interest in the demand for secure management of collapse detection during demolition works. Therefore, this study aims to investigate the applicability of real-time safety monitoring systems using a total station capable of 3D automatic displacement measurement in building demolition work for securing structural safety by the load changes during the demolition process.

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