• 인터넷정보학회논문지
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• 제20권3호
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• pp.69-75
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• 2019

The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.

• Toxicological Research
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• 제1권1호
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• pp.31-41
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• 1985

The Japanese Good Laboratory Practice (GLP) Standard on Drugs was finalized as a guideline and implemented in April, 1983. This standard is intended to ensure the quality and integrity of the data from nonclinical toxicity studies submitted to the Ministry of Health and Welfare in support of applications for approval to manufacture or import new drugs or to be used in the reevaluation of previously approved drugs. The standard includes a guideline for organizational matters, personnel, facility, equipment, testing operation, documentation and conduct of studies. Principles and influences of implementation of Japanese GLP will be discussed briefly in comparison with foreign GLPs.

• 대한안전경영과학회지
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• 제17권2호
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• pp.67-78
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• 2015

The purpose of the establishment of corporation's Business Continuity Plan(BCP) is to maintain corporations' own business and establish the response plan in order to resume operation in a short time period when crisis situations occur due to natural disaster and human error. This study has presented all types of procedures and criteria which are needed to establish the airport crisis response system in order to maintain the business continuity by utilizing BCP technique. Basically the risk response procedures must be established in the process of (1) preparation stage, (2) plan development stage, (3) documentation stage, (4) test & maintenance stage. The guideline has been suggested that each stage must be carried out in the sequence of Policy & Planning Responsibility, Business Impact Analysis, Recovery Strategy & Plans, Emergency Plan & SOP, Training Awareness and Maintenance & Review

• 한국문헌정보학회지
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• 제40권4호
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• pp.199-219
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• 2006

보유일정표는 공공업무를 체계적으로 기록화하기 위해 가장 중요한 도구이다. 이 연구의 목적은(구)기록물관리법 에 의한 기록물분류기준표를 대신하여, 체계적인 기록화 도구로서 기능할 수 있는 보유일정표 설계 방안을 제시하는 것이다. 이를 위해 우선 ISO 15489를 기반으로 보유일정표의 역할을 정립해보고자 하였다 보유일정표 설계를 위해 호주, 미국, 우리나라 등 각국의 국가 차원의 보유일정표 체계를 비교 분석하였다. 분석의 주요 측면은 보유일정표의 유형, 구조. 구성요소로 설정하였다. 이러한 분석을 토대로 정부기록을 위한 보유일정표 재설계 방안을 제안하였다.

• 임상간호연구
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• 제21권2호
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• pp.154-168
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• 2015

Purpose: This study aimed to adapt the previously developed, high-quality oral care guideline for the usage in clinical settings in Korea. Methods: Guideline adaptation process was undertaken according to the guideline adaptation manual version 2.0 developed by National Evidence-based Healthcare Collaborating Agency (Kim, et al., 2011) and the standardized methodology for nursing practice guideline adaptation (Gu, et al. 2012). Results: The adapted oral care guideline was consisted of 10 domains and 85 recommendations. The number of recommendations in each domain were: 4 general issues, 2 oral care indications, 10 oral assessment 16 general oral care, 15 oral care for critically ill, 15 oral care for cancer patients, 14 oral care for cancer patients withoral complications, 5 oral careeducation, 2 oral care referral, and 2 documentation and report. Ten point six percent of the recommendations were rated as grade A, 20.0% as grade B grade, and more than half (69.4%) were rated as grade C. Conclusion: The adapted oral care practice guideline is expected to included the evidence-based practice guidelines as fundamentalss of nursing practice. Dissemination of the developed guideline nationwide would contribute improving the efficiency of oral care practice.

• 임상간호연구
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• 제26권2호
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• pp.141-153
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• 2020

Purpose: This study aimed to update the previously published nursing practice guideline for oral care. Methods: The guideline were updated according to the manuals developed by National Institute for Health and Care Excellence (NICE) and Scottish Intercollegiate Guidelines Network (SIGN), and a Handbook for Clinical Practice Guideline Developer Version 1.0. Results: Updated nursing practice guideline for oral care was consisted of 10 domains and 79 recommendations. The number of recommendations in each domain were: 5 general issues, 2 oral care indications, 9 oral assessment, 16 general oral care, 12 oral care for critically ill patients, 16 oral care for cancer patients, 12 oral care for cancer patients with oral complications, 5 oral care education, 1 oral care referral, and 1 documentation and report. In terms of grades for recommendations, 11.4% was grade A, 17.0% was grade B, and 68.2% was grade C. Twelve new recommendations were developed and 7 previous recommendations were deleted. Conclusion: Updated nursing practice guideline for oral care is expected to serve as an evidence-based practice guideline for oral care in South Korea. It is recommended that this guideline be spread to clinical nursing settings nationwide to improve the effectiveness of oral care practice.

• 임상간호연구
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• 제23권3호
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• pp.361-375
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• 2017

Purpose: This study was conducted to update the existing nursing practice guideline for intravenous infusion guidelines according to the evidence-based practice guideline in South Korea. Methods: Guideline update process was performed using 22 steps according to the manuals developed by NICE and SIGN. Results: Updated nursing practice guidelines for the intravenous infusion were consisted of 23 domains and 322 recommendations. The number of recommendations in each domain were 4 for general instruction, 12 for vascular access device selection, 20 for site selection, 9 for insertion, 54 for stabilization, 21 for maintaining patency, 4 for blood sampling, 33 for exchange and removal, 28 for add-on device selection, 28, 72 for infusion related complications, 56 for infusion therapies, 7 for education, and 2 for documentation and report. There were 15.9% of A, 30.2% of B, 53.9% of C in terms of grade recommendations. A total of 178 (51.6%) recommendations were newly developed and 24 previous recommendations have been deleted. Conclusion: Updated nursing practice guideline for intravenous infusion was expected to be an evidence-based practice guideline for intravenous infusion in South Korea. This guideline is suggested to be disseminated to clinical nursing settings nationwide to improve the efficiency of intravenous infusion practice.

• 임상간호연구
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• 제20권2호
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• pp.147-161
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• 2014

Purpose: This study was aimed to modify and adapt the previously developed, high-quality enteral tube feeding guidelines for the usage in clinical settings in Korea. Methods: Guideline adaptation process was undertaken according to the guideline adaptation manual version 2.0 developed by NECA (Kim, et al., 2011) and the standardized methodology for nursing practice guideline adaptation (Gu, et al. 2012). Results: The modified and adapted enteral tube feeding guidelines were consisted of 11 domains and 95 recommendations. The domains and numbers of recommendations in each domain were: 4 on general issues, 2 on enteral nutrition indication and discontinue, 6 on enteral nutrition device selection, 12 on enteral tube feeding device insertions, 3 on enteral nutrition formular and choices, 16 on enteral tube feeding start and progress, 20 on enteral tube feeding maintenance and management, 15 on monitoring enteral tube feeding administration, 10 on prevention of error, 5 on medication administration, and 2 on documentation and report. There were 16.1% of the recommendations marked as A grade, 17.8% of B grade, and 66.1% of C grade. Conclusion: The adapted enteral tube feeding nursing practice guideline is to be added to the evidence-based practice guidelines for fundamentals of nursing practice. The guideline is hoped to be disseminated to nurses nationwide in order to improve the efficiency of enteral tube feeding practice.

• 한국경영과학회:학술대회논문집
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• 대한산업공학회/한국경영과학회 1994년도 춘계공동학술대회논문집; 창원대학교; 08월 09일 Apr. 1994
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• pp.344-354
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• 1994

In the development of executive information systems (EIS) the selection of an appropriate software package as a system building tool is regarded as a key technology. This paper attempts to shed some light on the evolving field of EIS software packages and provides a helpful Guideline for selecting the most suitable product by addressing significant considerations. A framework is presented that includes a six-step evaluation process: need analysis, team building, vendor survey, identification of decision criteria, and building an evaluation model and its verification. The major evaluation criteria of the full-featured software include: special functionality, reporting, graphics. decision support capability user friendliness, general functionality physical requirements, communication linkage, vendor support, cost related factors, performance, and documentation capability. An illustrative model using the analytic hierarchy process (AHP) method is also discussed to prove the appropriateness of our approach.

• 한국IT서비스학회지
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• 제5권1호
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• pp.129-147
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• 2006

This study analyzed an operational concept for the D Information Resource Management Information System (DIRMIS) to manage any IT resources effectively in defense area. We first deduced the concept of the information resource management (IRM) for defense area from the literature review, and we suggested a guideline, which has used in defense area, of the documentation for the operational concept description (OCD). Moreover, we developed the operational concept for the DIRMIS following the guideline. Especially, this study is a practical approach for suggesting of a case, and the share of accumulated cases will contribute to advance in System Integration (SI) industry as well as academic research.