Disparities versus Similarities: WHO GPPQCL and ISO/IEC 17025:2017 International Standards for Quality Management Systems in Pharmaceutical Laboratories

Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.

European Environmental Policy for Road Transport: Analysis of the Perverse Effects Generated and Proposals for a Good Practice Guide

The aim of this paper is to analyse the different environmental policies adopted in Europe for car emissions, to comment on some of the possible perverse effects generated and point out these policies which are considered more efficient under the environmental perspective. This paper is focused on passenger cars as this category is the most significant in road transport. The utility of this research lies in this being the first step or basis to improve and optimise actual policies. The methodology applied in this paper refers to a comparative analysis from a practical and theoretical point of view of European environmental policies in road transport. This work describes an overview of the road transport industry in Europe pointing out some relevant aspects such as the contribution of road transport to total emissions and the vehicle fleet in Europe. Additionally, we propose a brief practice guide with the combined policies in order to optimise their aim.

Management Directions towards Social Responsibility in Special Population Groups by Airport Enterprises: The Case of Autism

Air transport links markets and individuals, promoting social and economic development. The review of management direction towards social responsibility and especially for the enhancement of passengers with autism is the key objective of this paper. According to a top-down approach, the key dimensions that affect the basic principles and directions of airport enterprises management towards social responsibility for the case of passengers with autism are presented. Conventional wisdom is to present actions undertaken in improving accessibility for special population groups and highlight the social dimension in the management of transport hubs. The target is to focus on transport hubs serving special groups of passengers such as passengers with autism and highlight good practices and motivate transport infrastructure management authorities and decision makers to promote the social footprint of transport. The highlights and key findings are essential for managers and decision makers to support actions and plans towards management of airport enterprises towards social responsibility, focusing on the case of passengers traveling with Autism Spectrum Disorder (ASD).

A Six-Year Case Study Evaluating the Stakeholders’ Requirements and Satisfaction in Higher Educational Establishments

Worldwide and mainly in the European Union, many standards, regulations, models and systems exists for the evaluation and identification of stakeholders’ requirements of individual universities and higher education (HE) in general. All systems are targeting to measure or evaluate the Universities’ Quality Assurance Systems and the services offered to the recipients of HE, mainly the students. Numerous surveys were conducted in the past either by each university or by organized bodies to identify the students’ satisfaction or to evaluate to what extent these requirements are fulfilled. In this paper, the main results of an ongoing 6-year joint research will be presented very briefly. This research deals with an in depth investigation of student’s satisfaction, students personal requirements, a cup analysis among these two parameters and compares different universities. Through this research an attempt will be made to address four very important questions in higher education establishments (HEE): (1) Are there any common requirements, parameters, good practices or questions that apply to a large number of universities that will assure that students’ requirements are fulfilled? (2) Up to what extent the individual programs of HEE fulfil the requirements of the stakeholders? (3) Are there any similarities on specific programs among European HEE? (4) To what extent the knowledge acquired in a specific course program is utilized or used in a specific country? For the execution of the research an internationally accepted questionnaire(s) was used to evaluate up to what extent the students’ requirements and satisfaction were fulfilled in 2012 and five years later (2017). Samples of students and or universities were taken from many European Universities. The questionnaires used, the sampling method and methodology adopted, as well as the comparison tables and results will be very valuable to any university that is willing to follow the same route and methodology or compare the results with their own HHE. Apart from the unique methodology, valuable results are demonstrated from the four case studies. There is a great difference between the student’s expectations or importance from what they are getting from their universities (in all parameters they are getting less). When there is a crisis or budget cut in HEE there is a direct impact to students. There are many differences on subjects taught in European universities.

Innovation in Information Technology Services: Framework to Improve the Effectiveness and Efficiency of Information Technology Service Management Processes, Projects and Decision Support Management

In a dynamic market of Information Technology (IT) Service and with high quality demands and high performance requirements in decreasing costs, it is imperative that IT companies invest organizational effort in order to increase the effectiveness of their Information Technology Service Management (ITSM) processes through the improvement of ITSM project management and through solid support to the strategic decision-making process of IT directors. In this article, the author presents an analysis of common issues of IT companies around the world, with strategic needs of information unmet that provoke their ITSM processes and projects management that do not achieve the effectiveness and efficiency expected of their results. In response to the issues raised, the author proposes a framework consisting of an innovative theoretical framework model of ITSM management and a technological solution aligned to the Information Technology Infrastructure Library (ITIL) good practices guidance and ISO/IEC 20000-1 requirements. The article describes a research that proves the proposed framework is able to integrate, manage and coordinate in a holistic way, measurable and auditable, all ITSM processes and projects of IT organization and utilize the effectiveness assessment achieved for their strategic decision-making process increasing the process maturity level and improving the capacity of an efficient management.

An Analysis of Institutional Audits: Basis for Teaching, Learning and Assessment Framework and Principles

The dynamism in education, particularly in the area of teaching, learning and assessment has caused Higher Education Institutions (HEIs) worldwide to seek for ways to continuously improve their educational processes. HEIs use outcomes of institutional audits, assessments and accreditations, for improvement. In this study, the published institutional audit reports of HEIs in the Sultanate of Oman were analyzed to produce features of good practice; identify challenges along Teaching, Learning Assessment (TLA); and propose a framework that puts major emphasis in having a quality-assured TLA, including a set of principles that can be used as basis in succeeding an institutional visit. The TLA framework, which shows the TLA components, characteristics of the components, related expectation, including implementation tool/ strategy and pitfalls can be used by HEIs to have an adequate understanding of the scope of audit and be able to satisfy institutional audit requirements. The scope of this study can be widened by exploring the other requirements of the Institutional Audits in the Sultanate of Oman, particularly the area on Governance and Management and Student Support Services.

The Impact of Bayh-Dole Act on Knowledge Transfer in the States and a Study on Applicability in Turkey

This study aims to contribute to efforts of Turkey to increase research and development to overcome mid-income level trap by discussing regulations on patenting and licensing. Knowledge and technology transfer from universities to business world is attached great significance to increase innovation. Through literature survey, it is observed that the States accomplished to boost the economy and increase welfare by the Bayh-Dole Act enacted in 1980. Thus, this good practice is imitated by other nations to make technological developments. The Act allows universities to acquire patent right in research programs funded by government to increase technology transfer from universities whilst motivating real sector to use research pools in the universities. An act similar with Bayh-Dole could be beneficial to Turkey since efforts in Turkey are to promote research, development and innovation. Towards this end, the impact of Bayh-Dole Act on the patent system for universities in the Sates is deliberately examined, applicability in Turkey is discussed. However, it is conceded that success rate of applying Bayh-Dole Act in Turkey would be low once Turkey mainly differs from the States regarding social, economic and cultural traits.

Different Roles for Mentors and Mentees in an e-Learning Environment

Given the increase in the number of students and administrators asking for online courses the author developed two partially online courses. One was a biology majors at genetics course while the other was a non-majors at biology course. The student body at Queensborough Community College is generally underprepared and has work and family obligations. As an educator, one has to be mindful about changing the pedagogical approach, therefore, special care was taken when designing the course material. Despite the initial concerns, both of these partially online courses were received really well by students. Lessons learnt were that student engagement is the key to success in an online course. Good practices to run a successful online course for underprepared students are discussed in this paper. Also discussed are the lessons learnt for making the eLearning environment better for all the students in the class, overachievers and underachievers alike.

From “Boat to Plate”: Creating Value through Sustainable Fish Supply Chain Visibility

Environmental concerns about the scarcity of marine resources are critical driving forces for firms aiming to prepare their supply chains for sustainability. Building on previous work, this paper highlights the implementation of good practices geared towards sustainable operations in the seafood department, which were pursued in an exploratory retailer case. Outcomes of the adopted environmentally and socially acceptable fish retailing strategies, ranged from traceability, to self-certification and eco-labelling. The consequences for business were, as follows: stronger collaboration and trust across the chain of custody, improvement of sponsors’ image and of consumers’ loyalty and, progress in the Greenpeace retailers’ evaluation ranking.

Opportunities and Options for Government to Promote Corporate Social Responsibility in the Czech Republic

The concept of corporate social responsibility (CSR) in the Czech Republic has evolved notably during the last few years and an issue that started as an interest- and motive-based activity for businesses is becoming more commonplace. Governments have a role to play in ensuring that corporations behave according to the rules and norms of society and can legislate, foster, collaborate with businesses and endorse good practice in order to facilitate the development of CSR. The purpose of this paper is to examine the opportunities and options of CSR in government policy and research its relevance to a business sector. An increasing number of companies is engaging in responsible activities, the public awareness of CSR is rising, and customers are giving higher importance to CSR of companies in their choice. By drawing on existing CSR approach in Czech and understanding of CSR are demonstrated. The paper provides an overview, more detailed government approach of CSR.

Financial Sources and Instruments for Public Grants and Financial Facilities of Smes in EU

Mostly of public financing programs at national and regional level are funded from European Union sources. EU can participate directly to a national and regional program (example LEADER initiative, URBAN…) or indirectly by funding regional or national funds.Funds from European Union are provided from EU multiannual financial framework form which the annual budget is programmed. The adjusted program 2007-2013 of the EU considered commitments of almost 1 trillion Euros for the EU-28 countries. Provisions of the new program 2014-2020 consider commitments of more than 1 trillion Euros. Sustainable growth, divided to Cohesion and Competitiveness for Growth an Employment, is one of the two principal categories; the other is the preservation and management of natural resources.Through this financing process SMEs benefited of EU and public sources by receiving grants for their investments. Most of the financial instruments are available indirectly through the national financial intermediaries. Part of them is managed by the European Investment Fund.The paper focuses on the public financing to SMEs by examining case studies on divers forms of public help. It tries to distinguish the efficiency of the examined good practices and therefore try to have some conclusions on the possibility of application to other regions.

Good Practices in the Development of the Erasmus Mundus Master program in Color in Informatics and Media Technology

The main objective of this paper is to identify and disseminate good practice in quality assurance and enhancement as well as in teaching and learning at master level. This paper focuses on the experience of the Erasmus Mundus Master program CIMET (Color in Informatics and Media Technology). Amongst topics covered, we discuss the adjustments necessary to a curriculum designed for excellent international students and their preparation for a global labor market.

Is E-learning Based On Learning Theories? A Literature Review

E-learning aims to build knowledge and skills in order to enhance the quality of learning. Research has shown that the majority of the e-learning solutions lack in pedagogical background and present some serious deficiencies regarding teaching strategies and content delivery, time and pace management, interface design and preservation of learners- focus. The aim of this review is to approach the design of e-learning solutions with a pedagogical perspective and to present some good practices of e-learning design grounded on the core principles of Learning Theories (LTs).

Technological Innovation Capabilities and Firm Performance

Technological innovation capability (TIC) is defined as a comprehensive set of characteristics of a firm that facilities and supports its technological innovation strategies. An audit to evaluate the TICs of a firm may trigger improvement in its future practices. Such an audit can be used by the firm for self assessment or third-party independent assessment to identify problems of its capability status. This paper attempts to develop such an auditing framework that can help to determine the subtle links between innovation capabilities and business performance; and to enable the auditor to determine whether good practice is in place. The seven TICs in this study include learning, R&D, resources allocation, manufacturing, marketing, organization and strategic planning capabilities. Empirical data was acquired through a survey study of 200 manufacturing firms in the Hong Kong/Pearl River Delta (HK/PRD) region. Structural equation modelling was employed to examine the relationships among TICs and various performance indicators: sales performance, innovation performance, product performance, and sales growth. The results revealed that different TICs have different impacts on different performance measures. Organization capability was found to have the most influential impact. Hong Kong manufacturers are now facing the challenge of high-mix-low-volume customer orders. In order to cope with this change, good capability in organizing different activities among various departments is critical to the success of a company.

Global Product Development Ways in Modern Thai Economy – Case Studies, Good Practices and Ways to Implement in Thailand

Advances in technology (e.g. the internet, telecommunication) and political changes (fewer trade barriers and an enlarged European Union, ASEAN, NAFTA and other organizations) have led to develop international competition and expand into new markets. Companies in Thailand, Asia and around the globe are increasingly being pressured on price and for faster time to enter the market. At the same time, new markets are appearing and many companies are looking for changes and shifts in their domestic markets. These factors have enabled the rapid growth for companies and globalizing many different business activities during the product development process from research and development (R&D) to production. This research will show and clarify methods how to develop global product. Also, it will show how important is a global product impact into Thai Economy development.

Software Process Improvement: A Organizational Change that Need to be Managed and Motivated

As seen in literature, about 70% of the improvement initiatives fail, and a significant number do not even get started. This paper analyses the problem of failing initiatives on Software Process Improvement (SPI), and proposes good practices supported by motivational tools that can help minimizing failures. It elaborates on the hypothesis that human factors are poorly addressed by deployers, especially because implementation guides usually emphasize only technical factors. This research was conducted with SPI deployers and analyses 32 SPI initiatives. The results indicate that although human factors are not commonly highlighted in guidelines, the successful initiatives usually address human factors implicitly. This research shows that practices based on human factors indeed perform a crucial role on successful implantations of SPI, proposes change management as a theoretical framework to introduce those practices in the SPI context and suggests some motivational tools based on SPI deployers experience to support it.

Preliminary Analysis of Energy Efficiency in Data Center: Case Study

As the data-driven economy is growing faster than ever and the demand for energy is being spurred, we are facing unprecedented challenges of improving energy efficiency in data centers. Effectively maximizing energy efficiency or minimising the cooling energy demand is becoming pervasive for data centers. This paper investigates overall energy consumption and the energy efficiency of cooling system for a data center in Finland as a case study. The power, cooling and energy consumption characteristics and operation condition of facilities are examined and analysed. Potential energy and cooling saving opportunities are identified and further suggestions for improving the performance of cooling system are put forward. Results are presented as a comprehensive evaluation of both the energy performance and good practices of energy efficient cooling operations for the data center. Utilization of an energy recovery concept for cooling system is proposed. The conclusion we can draw is that even though the analysed data center demonstrated relatively high energy efficiency, based on its power usage effectiveness value, there is still a significant potential for energy saving from its cooling systems.

An Assessment of Software Process Optimization Compared to International Best Practice in Bangladesh

The challenge for software development house in Bangladesh is to find a path of using minimum process rather than CMMI or ISO type gigantic practice and process area. The small and medium size organization in Bangladesh wants to ensure minimum basic Software Process Improvement (SPI) in day to day operational activities. Perhaps, the basic practices will ensure to realize their company's improvement goals. This paper focuses on the key issues in basic software practices for small and medium size software organizations, who are unable to effort the CMMI, ISO, ITIL etc. compliance certifications. This research also suggests a basic software process practices model for Bangladesh and it will show the mapping of our suggestions with international best practice. In this IT competitive world for software process improvement, Small and medium size software companies that require collaboration and strengthening to transform their current perspective into inseparable global IT scenario. This research performed some investigations and analysis on some projects- life cycle, current good practice, effective approach, reality and pain area of practitioners, etc. We did some reasoning, root cause analysis, comparative analysis of various approach, method, practice and justifications of CMMI and real life. We did avoid reinventing the wheel, where our focus is for minimal practice, which will ensure a dignified satisfaction between organizations and software customer.