• Title/Summary/Keyword: Approval standard

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Suggestions for Solving Errors and Integrity Guarantees in the Process of Transferring Standard Electronic Documents (표준 전자문서 이관 시 발생하는 무결성 보장 및 오류 해결에 대한 제언)

  • Yu, Young-Moon
    • Journal of Korean Society of Archives and Records Management
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    • v.20 no.3
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    • pp.1-21
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    • 2020
  • Although the National Archives of Korea has been receiving transfer of standard electronic documents with a retention period of more than 30 years from the central administration since 2015, errors and inefficiencies persist. Despite this, however, there remain no studies that analyze or address these issues. This study aims to bridge this gap and found that most errors in the transfer process occur at the production stage. To address such, this study proposes a four-step solution. First, before electronic document approval, the text and attached files are checked for defects to prevent errors. Second, as soon as the signature is made, digital signatures are applied on a file-by-file basis to ensure integrity. Third, integrity verification and transfer inspection are automatically performed through digital signature investigation and defect check procedure during transfer and preservation. Fourth and last, the criteria of acquiring records and integrity guarantee technologies are properly applied in production stage with proper management and supervision.

New Drug Listing Process and Reimbursement Standard Management (약제의 신규등재 절차와 급여기준 관리)

  • Yoon Kyeong Bai;Mi-Young You
    • Journal of Digestive Cancer Research
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    • v.11 no.2
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    • pp.104-107
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    • 2023
  • The Ministry of Health and Welfare of Korea has implemented various social security programs to ensure a basic standard of living and raise overall quality of life for all citizens. The Korean social security system provides social insurance, public assistance, and social welfare services. To achieve adequate drug benefits, the Drug Management Department of Health Insurance Review and Assessment Service (HIRA) implement drug management duties including drug listing, upper price limit setting, scope of benefits, and post-factum management. When a manufacturer or an importer wants to apply for National Health Insurance (NHI) coverage of the drug that has obtained safety and efficacy approval, the pharmaceutical benefit assessment committee of HIRA evaluates the drug's clinical efficacy and cost-effectiveness to determine whether or not to include the drug into the benefit package. The benefit standards for a listed drug (ingredient) are set either for the whole permitted range or a part of range with conditions. To increase the coverage rate for new drugs, the listed drugs are regularly reviewed for their value. The status of listed drugs can be adjusted or eliminated from the benefit package if the clinical efficacy turns out to be insignificant. Therefore, through these pharmaceutical management procedures, high-quality drugs are provided at reasonable prices, which save healthcare expenditure by price determination and selective coverage in consideration of economic evaluation.

A Study on Improving the Evaluation Standard for the Law School : Focusing on the Evaluation Clauses of Law School Library (법학전문대학원 평가기준 개선에 관한 연구 - 법학전문도서관 평가조항을 중심으로 -)

  • Chung, Jae-Young
    • Journal of Korean Library and Information Science Society
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    • v.44 no.1
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    • pp.123-142
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    • 2013
  • The evaluation of the law schools, which had been launched for the purpose of training the lawyers to settle the legal disputes professionally and effectively, had been done on paper and on site from September through October 2012. Based on not only the basic materials for the evaluation such as evaluation standard, manual, and questionnaire but also the problems revealed during the evaluation, this study intended to show the problems of the evaluation clauses of the law school library which is the basis for the professionalism and diversity of law education and suggest the remedies for them. This study shows that the evaluation clauses need to be made considering the scale of each law school rather than suggesting the same quantitative standard in every law school and to be more specific rather than abstract. Especially, to manage the law school library efficiently from now on, it is necessary to plan and practice the idea of developing such as the specialization and to prepare the idea of operating the law school library through the law school members. Additionally, it is desirable that the chapter of the library exists separately and the library facilities are evaluated together with the other school facilities. Lastly, it is necessary to suggest the appropriate model as the norm to each school according to the school scale.

Stability Evaluation of National Reference Standards for Blood Products in Korea

  • Park, Tae Jun;Choi, Chan Woong;Oh, Ho Kyung;Kim, Jae Ok;Kim, Byung Kuk;Kang, Hyun Kyung;Kwon, Eun Jeong;Gweon, Eun Jeong;Park, Sang Jin;Kang, Ho Il;Jung, Ki Kyung;Park, Sang Mi;Kim, Ji Hye;Han, Ki Won;Jeong, Ja Young
    • Toxicological Research
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    • v.33 no.3
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    • pp.225-231
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    • 2017
  • National reference standards (NRSs) for biologics are established through potency estimation by a multi-center joint study of standard materials used in the approval process for national lot release and quality control of vaccines, blood products, and other biologics. In this study, a stability evaluation was conducted to determine whether the potency of NRSs for six blood products was being maintained at a consistent level in Korea. The present study conducted real-time stability tests via in-vivo/in-vitro bioassay on NRSs for blood coagulation factor VIII concentrate (2nd standard), antithrombin concentrate, prekallikrein activator, anti-hepatitis B immunoglobulin, blood coagulation factor IX concentrate, and anti-tetanus human immunoglobulin, as well as a trend analysis using cumulative annual results. The real-time stability test results showed that the mean potency of six NRSs was all within the control limit. In the trend analysis, the potency of NRS for blood coagulation factor VIII concentrate (2nd standard) showed a decreasing trend, while the potency of all other products had been stably maintained. The present study confirmed that the mean potency of NRSs for six blood products had been stably maintained in Korea. The findings of the present study establish a foundation that can ensure the quality of NRSs for biologics in Korea, and it is expected to make a major contribution to the supply of high-quality biologics.

Establishment of Plasma Working Standards for the Performance and Quality Assurance of NAT Screening Tests for HIV, HCV and HBV (HIV, HCV와 HBV 유전자 분석시약의 성능 및 품질관리용 Plasma Working Standards 제조에 관한 연구)

  • Kim, Myung Han;Cho, Youn Jung;Kwon, So-Yong;Cho, Nam Sun
    • The Korean Journal of Blood Transfusion
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    • v.23 no.2
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    • pp.152-161
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    • 2012
  • Background: Since Jan. 2012, for performance evaluation of viral reagents, analysis of domestic samples has been recommended in order to obtain approval from the KFDA when they are first introduced to Korea. This regulation requires the standard domestic materials driven from locally infected samples. We tried manufacturing the plasma working standards of HBV, HCV, and HIV NAT using a mixed titer of viral loads. Methods: Forty three HBV DNA positive plasmas, 25 HCV RNA positive plasmas, and 26 HIV RNA positive plasmas were evaluated according to viral load and genotype. Several plasma units, which had high-titer viral loads and the common viral genotypes in Korea, were selected as the source materials for each viral standard. To adjust the appropriate concentration based on the detectable range of variable viral reagents, the source plasma was diluted to several concentrations, divided into small vials, and analyzed for quantification. Results: The 13 plasma working standards, which had variable viral loads for the mixed titer performance panel of HIV, HCV, and HBV NAT, were produced. Conclusion: These national standard materials were first produced in order to supply the mixed titer performance panel for the viral NAT reagent of the level IV transfusion related high-risk group in Korea.

An Establishment of Functional Test Facility for ICT-Convergence Equipment of Vessel : Focused on Maritime Digital Interfaces and Main Navigation Communication Systems (선박 ICT융합 장비 기능시험 시설 구축 연구 : 선박 디지털 인터페이스 및 주요 항해통신장비를 중심으로)

  • Hwang, Hun-Gyu;Kim, Bae-Sung;Woo, Snag-Min;Woo, Yun-Tae;Shin, Il-Sik
    • Journal of the Korea Institute of Information and Communication Engineering
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    • v.22 no.5
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    • pp.754-763
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    • 2018
  • The maritime ICT-convergence equipment are essentially required to a type approval (TA) certification that needs environmental and functional tests, to install in vessel. The environmental test is to experiment the possession for required durabilities of the target device in maritime environment, and the functional test is to check the required functions of target equipment based on international standard. In Korea, the environmental testing facilities amount to 227 sites, but there is no functional testing facility. Because of this, we establish a function test facility for the maritime ICT-equipment. In this paper, we analyze and design the functional testing requirement and required interlocking simulators for digital interfaces and navigation communication equipment. We propose the 2-steps of functional testing procedures, which are single test and integration test, to improve the reliability of testing result. The single test is to examine own functions of the target device, and the integration test is to check harmonized operation with other navigation and communication devices.

A Study on Trade Automation in Korea (한국의 무역자동화에 관한 고찰)

  • 전재경;이재승
    • Journal of the Korea Society of Computer and Information
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    • v.3 no.3
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    • pp.139-150
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    • 1998
  • Due to development of science and telecommunication with wide-spread computer supply, it could be done through computer automatically instead of manpower-work for paper transportation & paper approval. It is developed to so-called Factory Automation. Further, it is developed to Office Automation. Trading companies & concerned trade authorities are interested in Trade Automation that such technique is applied to trade work. Generally, Trade Automation means to realize paperless trade by exchanging electronic papers through inter-computers after concerned trade operators transformed various papers to electronic papers that computer could read. In case Trade Automation fix in the trade business, it is expected one of innovations among traditional paper work of trade business, namely without going import-export authorities, Customs office, Banks. Shipping companies, Marine insurance companies on hand-carrying papers, it could be fast, simple, correct to finish every trade procedures such as commercial business, foreign currency, customs clearance, transportations, insurance. terms of payment, etc., with Electronic Data Interchange through computer facilities. Especially, telecommunication for trade form could be helpful to proceed trade paper with one-run-method Further we can anticipate 6 effects for Trade Automation as belows : First, as explained just above articles, with completion for Trade Automation, every trade procedures can be done by computer. so, time to work can be diminished. namely. logistics cost including accessory costs for trade procedures can be saved much. Second, viewing to private enterprise, effect of Office Automation can be maximized and rapid, correct exchange for various trade informations could raise efficiency of enterprise management establishing rational production, storage, transportation and could raise competition improving standard for consumers's service. Third, establishing Trade Automation systems makes it easier piling-up of harbor cargo by pre-transmission of electronic paper & trade informations make it possible to finish customs clearance in advance and can be dispatched upon cargo arrival. Fourth, most of concerned trade authorities such as import-export approval office. financial authorities, transport & insurance companies concentrated in Metropolitan area(Seoul, In -Cheon, Kyung-Ki). Therefore, in case Trade Automation could be realized. it is possible to proceed trade business instantly in every country area by computer facilities. Also. it contribute well-balanced development for suburb. region area by suburb dispersion of trading companies. Fifth, on the way to Trade Automation establishment & its enlargement process. producing enormous demand for over-all telecommunication such as hardware. software. network makes opportunity to progress telecommunication industry & concerned industries. Finally. Trade Automation accelerate change of employment structure leading unnecessary labors on the industries of office & logistics to manufacturing area.

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Manual Development Research for the Diagnosis of the Introduction of Low-Floor Bus (저상버스 도입진단 매뉴얼 개발 연구)

  • Seung jun Lee;Seong yeon Kim;Won Jun Lee;Hyunjun Park;Choul Ki Lee;Nam sun Kim
    • The Journal of The Korea Institute of Intelligent Transport Systems
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    • v.22 no.6
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    • pp.208-222
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    • 2023
  • With the recent revision of 「Act on Promotion of the Transportation Convenience of Mobility Disadvantaged Persons」 and the Enforcement Regulations of the Act, bus business operators must introduce low-floor buses when scrapping buses. On the other hand, in the case of routes where low-floor buses cannot be operated, bus business operators can be exempted from introducing low-floor buses with the approval of their transportation administrative agency according to Article 4-2 of 「Enforcement Regulation of the Act on Promotion of the Transportation Convenience of Mobility Disadvantaged Persons」. According to the data from the Korea Bus Transportation Associations Federation, approximately 5.9% of all city bus routes were surveyed as the exceptions to introducing low-floor buses. Nevertheless the proportion is expected to increase because some regions with difficulties introducing low-floor buses are not included when calculating the proportion. By confirming the process of approving exceptions for introducing low-floor buses through local governments, there was no specific examination method or standard for approval of exceptions. Hence, there is the problem that some routes are approved as exceptions to introducing low-floor buses, even though low-floor buses can be operated on those routes. Therefore, this study aims to develop a manual that can objectively diagnose the overall operation environment of low-floor buses, such as road geometry and road facilities. Future research plans to apply it to more cases and improve it for more precise application in various contexts.

Development of a 4S Multiple Media Switching Server and an Information Exchange System (4S 다중매체 스위칭 서버와 육해상 정보교환 시스템 개발)

  • Mun, Seong-Mi;Jang, Won-Seok;Son, Joo Yong;Yang, Gyu-Sik
    • Journal of Navigation and Port Research
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    • v.37 no.3
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    • pp.275-281
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    • 2013
  • Ship Standard Network was submitted as a common subject of e-navigation by 81th IMO MSC 2005. This agenda was given an official status with strategy planning of e-navigation for Ship Standard Network after approval of WG program of 81th MSC 2006. Nowadays approximately 400 heterogeneous navigation and communication equipments are working on ships at sea. Standardization of ship network is to support exchanging various data efficiently. Among them, 4S network is defined as a wireless communication network between ship to ship and ship to shore which provides unceasing communication channel ship to shore. It has been expected to trigger various services and applications based on 4S network. However, no technologies and products has been appeared at fields yet. but now there's not specific technologies and developing products. In this paper, We developed a 4S multiple media switching server and a ship-land information exchange system to overcome the heterogeneity and provide efficient communication environments.. The performance of the implemented system was verified by TTA(Telecommunications Technology Association) V&V(Verification and Validation).

Review on asbestos analysis (석면 분석방법에 대한 고찰)

  • Ham, Seung hon;Hwang, Sung Ho;Yoon, Chungsik;Park, Donguk
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.19 no.3
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    • pp.213-232
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    • 2009
  • This document was prepared to review and summarize the analytical methods for airborne and bulk asbestos. Basic principles, shortcomings and advantages for asbestos analytical instruments using phase contrast microscopy(PCM), polarized light microscopy(PLM), X-ray diffractometer (XRD), transmission electron microscopy(TEM), scanning electron microscopy(SEM) were reviewed. Both PCM and PLM are principal instrument for airborne and bulk asbestos analysis, respectively. If needed, analytical electron microscopy is employed to confirm asbestos identification. PCM is used originally for workplace airborne asbestos fiber and its application has been expanded to measure airborne fiber. Shortcoming of PCM is that it cannot differentiate true asbestos from non asbestos fiber form and its low resolution limit ($0.2{\sim}0.25{\mu}m$). The measurement of airborne asbestos fiber can be performed by EPA's Asbestos Hazard Emergency Response Act (AHERA) method, World Health Organization (WHO) method, International Standard Organization (ISO) 10312 method, Japan's Environmental Asbestos Monitoring method, and Standard method of Indoor Air Quality of Korea. The measurement of airborne asbestos fiber in workplace can be performed by National Institute for Occupational Safety and Health (NIOSH) 7400 method, NIOSH 7402 method, Occupational Safety and Health Administration (OSHA) ID-160 method, UK's Health and Safety Executive(HSE) Methods for the determination of hazardous substances (MDHS) 39/4 method and Korea Occupational Safety and Health Agency (KOSHA) CODE-A-1-2004 method of Korea. To analyze the bulk asbestos, stereo microscope (SM) and PLM is required by EPA -600/R-93/116 method. Most bulk asbestos can be identified by SM and PLM but one limitation of PLM is that it can not see very thin fiber (i.e., < $0.25{\mu}m$). Bulk asbestos analytical methods, including EPA-600/M4-82-020, EPA-600/R-93/116, OSHA ID-191, Laboratory approval program of New York were reviewed. Also, analytical methods for asbestos in soil, dust, water were briefly discussed. Analytical electron microscope, a transmission electron microscope equipped with selected area electron diffraction (SAED) and energy dispersive X-ray analyser(EDXA), has been known to be better to identify asbestiform than scanning electron microscope(SEM). Though there is no standard SEM procedures, SEM is known to be more suitable to analyze long, thin fiber and more cost-effective. Field emission scanning electron microscope (FE-SEM) imaging protocol was developed to identify asbestos fiber. Although many asbestos analytical methods are available, there is no method that can be applied to all type of samples. In order to detect asbestos with confidence, all advantages and disadvantages of each instrument and method for given sample should be considered.