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.

Save Lives: The Application of Geolocation-Awareness Service in Iranian Pre-Hospital EMS Information Management System

For emergency and relief service providers such as pre-hospital emergencies, quick arrival at the scene of an accident or any EMS mission is one of the most important requirements of effective service delivery. EMS Response time (the interval between the time of the call and the time of arrival on scene) is a critical factor in determining the quality of pre-hospital Emergency Medical Services (EMS). This is especially important for heart attack, stroke, or accident patients that seconds are vital in saving their lives. Location-based e-services can be broadly defined as any service that provides information pertinent to the current location of an active mobile handset or precise address of landline phone call at a specific time window, regardless of the underlying delivery technology used to convey the information. According to research, one of the effective methods of meeting this goal is determining the location of the caller via the cooperation of landline and mobile phone operators in the country. The follow-up of the Communications Regulatory Authority (CRA) organization has resulted in the receipt of two separate secured electronic web services. Thus, to ensure human privacy, a secure technical architecture was required for launching the services in the pre-hospital EMS information management system. In addition, to quicken medics’ arrival at the patient's bedside, rescue vehicles should make use of an intelligent transportation system to estimate road traffic using a GPS-based mobile navigation system independent of the Internet. This paper seeks to illustrate the architecture of the practical national model used by the Iranian EMS organization.

Proposals for the Thermal Regulation of Buildings in Algeria: An Energy Label for Social Housing

Despite the international commitment of Algeria towards the development of energy efficiency and renewable energy in the country, the internal energy demand has been continuously growing during the last decade due to the substantial increase of population and of living conditions, which in turn has led to an unprecedented expansion of the residential building sector. The RTB (Thermal Building Regulation) is the technical document that establishes the calculation framework for the thermal performance of buildings in Algeria, setting up minimum obligatory targets for the thermal performance of new buildings. An update of this regulation is due in the coming years and this paper discusses some proposals in this regard, with the aim to improve the energy efficiency of the building sector, particularly with regard to social housing. In particular, it proposes a methodology for drafting an energy performance label of new Algerian residential buildings, moving from the results of the thermal compliance verification and sizing of technical systems as defined in the RTB. Such an energy performance label – whose calculation method is briefly described in the paper – aims to raise citizens' awareness of the benefits of energy efficiency. It can represent the first step in a process of integrating technical installations into the calculation of the energy performance of buildings in Algeria.

Thermosensitive Hydrogel Development for Its Possible Application in Cardiac Cell Therapy

Ischemic events can culminate in acute myocardial infarction with irreversible cardiac lesions that cannot be restored due to the limited regenerative capacity of the heart. Tissue engineering proposes therapeutic alternatives by using biomaterials to resemble the native extracellular medium combined with healthy and functional cells. This research focused on developing a natural thermosensitive hydrogel, its physical-chemical characterization and in vitro biocompatibility determination. Hydrogels’ morphological characterization was carried out through scanning electron microscopy and its chemical characterization by employing Infrared Spectroscopy technic. In addition, the biocompatibility was determined using fetal human ventricular cardiomyocytes cell line RL-14 and the MTT cytotoxicity test according to the ISO 10993-5 standard. Four biocompatible and thermosensitive hydrogels were obtained with a three-dimensional internal structure and two gelation times. The results show the potential of the hydrogel to increase the cell survival rate to the cardiac cell therapies under investigation and lay the foundations to continue with its characterization and biological evaluation both in vitro and in vivo models.

Incentive Policies to Promote Green Infrastructure in Urban Jordan

The wellbeing of urban dwellers is strongly associated with the quality and quantity of green infrastructure. Nevertheless, urban green infrastructure is still lagging in many Arab cities, and Jordan is no exception. The capital city of Jordan, Amman, is becoming more urban dense with limited green spaces. The unplanned urban growth in Amman has caused several environmental problems such as urban heat islands, air pollution and lack of green spaces. This study aims to investigate the most suitable drivers to leverage the implementation of urban green infrastructure in Jordan through qualitative and quantitative analysis. The qualitative research includes an extensive literature review to discuss the most common drivers used internationally to promote urban green infrastructure implementation in the literature. The quantitative study employs a questionnaire survey to rank the suitability of each driver. Consultants, contractors and policymakers were invited to fill the research questionnaire according to their judgments and opinions. Relative Importance Index has been used to calculate the weighted average of all drivers and the Kruskal-Wallis test to check the degree of agreement among groups. This study finds that research participants agreed that indirect financial incentives (i.e., tax reductions, reduction in stormwater utility fee, reduction of interest rate, density bonus etc.) are the most effective incentive policy whilst granting sustainability certificate policy is the least effective driver to ensure widespread of UGI is elements in Jordan.

Decision-Making Strategies on Smart Dairy Farms: A Review

Farm management and operations will drastically change due to access to real-time data, real-time forecasting and tracking of physical items in combination with Internet of Things (IoT) developments to further automate farm operations. Dairy farms have embraced technological innovations and procured vast amounts of permanent data streams during the past decade; however, the integration of this information to improve the whole farm decision-making process does not exist. It is now imperative to develop a system that can collect, integrate, manage, and analyze on-farm and off-farm data in real-time for practical and relevant environmental and economic actions. The developed systems, based on machine learning and artificial intelligence, need to be connected for useful output, a better understanding of the whole farming issue and environmental impact. Evolutionary Computing (EC) can be very effective in finding the optimal combination of sets of some objects and finally, in strategy determination. The system of the future should be able to manage the dairy farm as well as an experienced dairy farm manager with a team of the best agricultural advisors. All these changes should bring resilience and sustainability to dairy farming as well as improving and maintaining good animal welfare and the quality of dairy products. This review aims to provide an insight into the state-of-the-art of big data applications and EC in relation to smart dairy farming and identify the most important research and development challenges to be addressed in the future. Smart dairy farming influences every area of management and its uptake has become a continuing trend.

Impacts of E-Learning on Educational Policy: Policy of Sensitization and Training in E-Learning in Saudi Arabia

Saudi Arabia instituted the policy of sensitizing and training stakeholders for e-learning and witnessed wide adoption in many institutions. However, it is at the infancy stage and needs time to develop to mirror the US and UK. The majority of the higher education institutions in Saudi Arabia have adopted e-learning as an alternative to traditional methods to advance education. Conversely, effective implementation of the policy of sensitization and training of stakeholders for e-learning implementation has not been attained because of various challenges. The objectives included determining the challenges and opportunities of the e-learning policy of sensitization and training of stakeholders in Saudi Arabia's higher education and examining if sensitization and training of stakeholder's policy will help promote the implementation of e-learning in institutions. The study employed a descriptive research design based on qualitative analysis. The researcher recruited 295 students and 60 academic staff from four Saudi Arabian universities to participate in the study. An online questionnaire was used to collect the data. The data were then analyzed and reported both quantitatively and qualitatively. The analysis provided an in-depth understanding of the opportunities and challenges of e-learning policy in Saudi Arabian universities. The main challenges identified as internal challenges were the lack of educators’ interest in adopting the policy, and external challenges entailed lack of ICT infrastructure and Internet connectivity. The study recommends encouraging, sensitizing, and training all stakeholders to address these challenges and adopt the policy.

Energy Policy in Nigeria: Prospects and Challenges

Energy is the major force that drives any country`s socio-economic development. Without electricity, the country could be at risk of losing many potential investors. As such, good policy implementation could play a significant role in harnessing all the available energy resources. Nigeria has the prospects of meeting its energy demand and supply if there are good policies and proper implementation of them. The current energy supply needs to improve in order to meet the present and future demand. Sustainable energy development is the way forward. Renewable energy plays a significant role in socio-economic development of any country. Nigeria is a country blessed with abundant natural resources such as, solar radiation for solar power, water for hydropower, wind for wind power, and biomass from both plants and animal’s waste. Both conventional energy (fossil fuel) and unconventional energy (renewable) could be harmonized like in the case of energy mix or biofuels. Biofuels like biodiesel could be produced from biomass and combined with petro-diesel in different ratios. All these can be achieved if good policy is in place. The challenges could be well overcome with good policy, masses awareness, technological knowledge and other incentives that can attract investors in Nigerian energy sector.

A Commercial Building Plug Load Management System That Uses Internet of Things Technology to Automatically Identify Plugged-In Devices and Their Locations

Plug and process loads (PPLs) account for a large portion of U.S. commercial building energy use. There is a huge potential to reduce whole building consumption by targeting PPLs for energy savings measures or implementing some form of plug load management (PLM). Despite this potential, there has yet to be a widely adopted commercial PLM technology. This paper describes the Automatic Type and Location Identification System (ATLIS), a PLM system framework with automatic and dynamic load detection (ADLD). ADLD gives PLM systems the ability to automatically identify devices as they are plugged into the outlets of a building. The ATLIS framework takes advantage of smart, connected devices to identify device locations in a building, meter and control their power, and communicate this information to a central database. ATLIS includes five primary capabilities: location identification, communication, control, energy metering, and data storage. A laboratory proof of concept (PoC) demonstrated all but the energy metering capability, and these capabilities were validated using a series of system tests. The PoC was able to identify when a device was plugged into an outlet and the location of the device in the building. When a device was moved, the PoC’s dashboard and database were automatically updated with the new location. The PoC implemented controls to devices from the system dashboard so that devices maintained correct schedules regardless of where they were plugged in within the building. ATLIS’s primary technology application is improved PLM, but other applications include asset management, energy audits, and interoperability for grid-interactive efficient buildings. An ATLIS-based system could also be used to direct power to critical devices, such as ventilators, during a brownout or blackout. Such a framework is an opportunity to make PLM more widespread and reduce the amount of energy consumed by PPLs in current and future commercial buildings.

Evaluation of Iranian Standard for Assessment of Liquefaction Potential of Cohesionless Soils Based on Standard Penetration Test

In-situ testing is preferred to evaluate the liquefaction potential in cohesionless soils due to high disturbance during sampling. Although new in-situ methods with high accuracy have been developed, standard penetration test, the simplest and the oldest in-situ test, is still used due to the profusion of the recorded data. This paper reviews the Iranian standard of evaluating liquefaction potential in soils (codes 525) and compares the liquefaction assessment methods based on standard penetration test (SPT) results on cohesionless soil in this standard with the international standards. To this, methods for assessing liquefaction potential are compared with what is presented in standard 525. It is found that although the procedure used in Iranian standard of evaluating the potential of liquefaction has not been updated according to the new findings, it is a conservative procedure.

Method for Tuning Level Control Loops Based on Internal Model Control and Closed Loop Step Test Data

This paper describes a two-stage methodology derived from IMC (Internal Model Control) for tuning a PID (Proportional-Integral-Derivative) controller for levels or other integrating processes in an industrial environment. Focus is ease of use and implementation speed which are critical for an industrial application. Tuning can be done with minimum effort and without the need of time-consuming open-loop step tests on the plant. The first stage of the method applies to levels only: the vessel residence time is calculated from equipment dimensions and used to derive a set of preliminary PI (Proportional-Integral) settings with IMC. The second stage, re-tuning in closed-loop, applies to levels as well as other integrating processes: a tuning correction mechanism has been developed based on a series of closed-loop simulations with model errors. The tuning correction is done from a simple closed-loop step test and application of a generic correlation between observed overshoot and integral time correction. A spin-off of the method is that an estimate of the vessel residence time (levels) or open-loop process gain (other integrating process) is obtained from the closed-loop data.

An E-Maintenance IoT Sensor Node Designed for Fleets of Diverse Heavy-Duty Vehicles

E-maintenance is a relatively recent concept, generally referring to maintenance management by monitoring assets over the Internet. One of the key links in the chain of an e-maintenance system is data acquisition and transmission. Specifically for the case of a fleet of heavy-duty vehicles, where the main challenge is the diversity of the vehicles and vehicle-embedded self-diagnostic/reporting technologies, the design of the data acquisition and transmission unit is a demanding task. This is clear if one takes into account that a heavy-vehicles fleet assortment may range from vehicles with only a limited number of analog sensors monitored by dashboard light indicators and gauges to vehicles with plethora of sensors monitored by a vehicle computer producing digital reporting. The present work proposes an adaptable internet of things (IoT) sensor node that is capable of addressing this challenge. The proposed sensor node architecture is based on the increasingly popular single-board computer – expansion boards approach. In the proposed solution, the expansion boards undertake the tasks of position identification, cellular connectivity, connectivity to the vehicle computer, and connectivity to analog and digital sensors by means of a specially targeted design of expansion board. Specifically, the latter offers a number of adaptability features to cope with the diverse sensor types employed in different vehicles. In standard mode, the IoT sensor node communicates to the data center through cellular network, transmitting all digital/digitized sensor data, IoT device identity and position. Moreover, the proposed IoT sensor node offers connectivity, through WiFi and an appropriate application, to smart phones or tablets allowing the registration of additional vehicle- and driver-specific information and these data are also forwarded to the data center. All control and communication tasks of the IoT sensor node are performed by dedicated firmware.

Technical, Environmental, and Financial Assessment for the Optimal Sizing of a Run-of-River Small Hydropower Project: A Case Study in Colombia

Run-of-river (RoR) hydropower projects represent a viable, clean, and cost-effective alternative to dam-based plants and provide decentralized power production. However, RoR schemes’ cost-effectiveness depends on the proper selection of site and design flow, which is a challenging task because it requires multivariate analysis. In this respect, this study presents the development of an investment decision support tool for assessing the optimal size of an RoR scheme considering the technical, environmental, and cost constraints. The net present value (NPV) from a project perspective is used as an objective function for supporting the investment decision. The tool has been tested by applying it to an actual RoR project recently proposed in Colombia. The obtained results show that the optimum point in financial terms does not match the flow that maximizes energy generation from exploiting the river's available flow. For the case study, the flow that maximizes energy corresponds to a value of 5.1 m3/s. In comparison, an amount of 2.1 m3/s maximizes the investors NPV. Finally, a sensitivity analysis is performed to determine the NPV as a function of the debt rate changes and the electricity prices and the CapEx. Even for the worst-case scenario, the optimal size represents a positive business case with an NPV of 2.2 USD million and an internal rate of return (IRR) 1.5 times higher than the discount rate. 

IntelligentLogger: A Heavy-Duty Vehicles Fleet Management System Based on IoT and Smart Prediction Techniques

Both daily and long-term management of a heavy-duty vehicles and construction machinery fleet is an extremely complicated and hard to solve issue. This is mainly due to the diversity of the fleet vehicles – machinery, which concerns not only the vehicle types, but also their age/efficiency, as well as the fleet volume, which is often of the order of hundreds or even thousands of vehicles/machineries. In the present paper we present “InteligentLogger”, a holistic heavy-duty fleet management system covering a wide range of diverse fleet vehicles. This is based on specifically designed hardware and software for the automated vehicle health status and operational cost monitoring, for smart maintenance. InteligentLogger is characterized by high adaptability that permits to be tailored to practically any heavy-duty vehicle/machinery (of different technologies -modern or legacy- and of dissimilar uses). Contrary to conventional logistic systems, which are characterized by raised operational costs and often errors, InteligentLogger provides a cost-effective and reliable integrated solution for the e-management and e-maintenance of the fleet members. The InteligentLogger system offers the following unique features that guarantee successful heavy-duty vehicles/machineries fleet management: (a) Recording and storage of operating data of motorized construction machinery, in a reliable way and in real time, using specifically designed Internet of Things (IoT) sensor nodes that communicate through the available network infrastructures, e.g., 3G/LTE; (b) Use on any machine, regardless of its age, in a universal way; (c) Flexibility and complete customization both in terms of data collection, integration with 3rd party systems, as well as in terms of processing and drawing conclusions; (d) Validation, error reporting & correction, as well as update of the system’s database; (e) Artificial intelligence (AI) software, for processing information in real time, identifying out-of-normal behavior and generating alerts; (f) A MicroStrategy based enterprise BI, for modeling information and producing reports, dashboards, and alerts focusing on vehicles– machinery optimal usage, as well as maintenance and scraping policies; (g) Modular structure that allows low implementation costs in the basic fully functional version, but offers scalability without requiring a complete system upgrade.

Cybersecurity for Digital Twins in the Built Environment: Research Landscape, Industry Attitudes and Future Direction

Technological advances in the construction sector are helping to make smart cities a reality by means of Cyber-Physical Systems (CPS). CPS integrate information and the physical world through the use of Information Communication Technologies (ICT). An increasingly common goal in the built environment is to integrate Building Information Models (BIM) with Internet of Things (IoT) and sensor technologies using CPS. Future advances could see the adoption of digital twins, creating new opportunities for CPS using monitoring, simulation and optimisation technologies. However, researchers often fail to fully consider the security implications. To date, it is not widely possible to assimilate BIM data and cybersecurity concepts and, therefore, security has thus far been overlooked. This paper reviews the empirical literature concerning IoT applications in the built environment and discusses real-world applications of the IoT intended to enhance construction practices, people’s lives and bolster cybersecurity. Specifically, this research addresses two research questions: (a) How suitable are the current IoT and CPS security stacks to address the cybersecurity threats facing digital twins in the context of smart buildings and districts? and (b) What are the current obstacles to tackling cybersecurity threats to the built environment CPS? To answer these questions, this paper reviews the current state-of-the-art research concerning digital twins in the built environment, the IoT, BIM, urban cities and cybersecurity. The results of the findings of this study confirmed the importance of using digital twins in both IoT and BIM. Also, eight reference zones across Europe have gained special recognition for their contributions to the advancement of IoT science. Therefore, this paper evaluates the use of digital twins in CPS to arrive at recommendations for expanding BIM specifications to facilitate IoT compliance, bolster cybersecurity and integrate digital twin and city standards in the smart cities of the future.

Parametric Study of 3D Micro-Fin Tubes on Heat Transfer and Friction Factor

One area of special importance for the surface-level study of heat exchangers is tubes with internal micro-fins (< 0.5 mm tall). Micro-finned surfaces are a kind of extended solid surface in which energy is exchanged with water that acts as the source or sink of energy. Significant performance gains are possible for either shell, tube, or double pipe heat exchangers if the best surfaces are identified. The parametric studies of micro-finned tubes that have appeared in the literature left some key parameters unexplored. Specifically, they ignored three-dimensional (3D) micro-fin configurations, conduction heat transfer in the fins, and conduction in the solid surface below the micro-fins. Thus, this study aimed at implementing a parametric study of 3D micro-finned tubes that considered micro-fine height and discontinuity features. A 3D conductive and convective heat-transfer simulation through coupled solid and periodic fluid domains is applied in a commercial package, ANSYS Fluent 19.1. The simulation is steady-state with turbulent water flow cooling the inner wall of a tube with micro-fins. The simulation utilizes a constant and uniform temperature on the tube outer wall. Performance is mapped for 18 different simulation cases, including a smooth tube using a realizable k-ε turbulence model at a Reynolds number of 48,928. Results compared the performance of 3D tubes with results for the similar two-dimensional (2D) one. Results showed that the micro-fine height has a greater impact on performance factors than discontinuity features in 3D micro-fin tubes. A transformed 3D micro-fin tube can enhance heat transfer, and pressure drops up to 21% and 56% compared to a 2D one, respectfully.

The Application of Fuzzy Set Theory to Mobile Internet Advertisement Fraud Detection

This paper presents the application of fuzzy set theory to implement of mobile advertisement anti-fraud systems. Mobile anti-fraud is a method aiming to identify mobile advertisement fraudsters. One of the main problems of mobile anti-fraud is the lack of evidence to prove a user to be a fraudster. In this paper, we implement an application by using fuzzy set theory to demonstrate how to detect cheaters. The advantage of our method is that the hardship in detecting fraudsters in small data samples has been avoided. We achieved this by giving each user a suspicious degree showing how likely the user is cheating and decide whether a group of users (like all users of a certain APP) together to be fraudsters according to the average suspicious degree. This makes the process more accurate as the data of a single user is too small to be predictable.

The Impact of ISO 9001 Certification on Brazilian Firms’ Performance: Insights from Multiple Case Studies

The evolution of quality management by companies was strongly enabled by, among others, ISO 9001 certification, which is considered a crucial requirement for several customers. Likewise, performance measurement provides useful insights for companies to identify the reflection of their decision-making process on their improvement. One of the most used performance measurement models is the balanced scorecard (BSC), which uses four perspectives to address a firm’s performance: financial, internal process, customer satisfaction, and learning and growth. Since ISO 9001 certified firms are likely to measure their performance through BSC approach, it is important to verify whether the certificate influences the firm performance or not. Therefore, this paper aims to verify the impact of ISO 9001:2015 on Brazilian firms’ performance based on the BSC perspective. Hence, nine certified companies located in the Southeast region of Brazil were studied through a multiple case study approach. Within this study, it was possible to identify the positive impact of ISO 9001 on firms’ overall performance, and four Critical Success Factors (CSFs) were identified as relevant on the linkage among ISO 9001 and firms’ performance: employee involvement, top management, process management, and customer focus. Due to the COVID-19 pandemic, the number of interviews was limited to the quality manager specialist, and the sample was limited since several companies were closed during the period of the study. This study presents an in-depth analysis of how the relationship between ISO 9001 certification and firms’ performance in a developing country is.

Ballistics of Main Seat Ejection Cartridges for Aircraft Application

This article outlines the ballistics of main seat ejection cartridges for aircraft application. The ballistics of main seat ejection cartridges plays a vital role during the ejection of the pilot in an emergency. The ballistic parameters such as maximum pressure, time to reach the maximum pressure, and time required to reach half the maximum pressure that responsible to the spinal injury of the pilot are assessed. Therefore, the evaluations of these parameters are very critical during various stages of development. Elaborate testing is carried out for main seat ejection cartridges on seat ejection tower (SET) at different operating temperatures considering physiological limits. As these trials are cumbersome in nature, a vented vessel (VV) testing facility is devised to lay down the performance parameters at hot and cold temperature conditions. Single base (SB) propellant having hepta-tubular configuration is selected as the main filling. Gun powder plays the role of a booster based on ballistic requirements. The evaluation methodology of various performance parameters of main seat ejection cartridges is explained in this paper. Physiological parameters such as maximum seat ejection velocity, acceleration, and rate of rising of acceleration are also experimentally determined on SET. All the parameters are observed well within physiological limits. This paper addresses the internal ballistic of main seat ejection cartridges, propellant selection, its calculation, and evaluation of various performance parameters for aircraft application.

Shaking Force Balancing of Mechanisms: An Overview

The balancing of mechanisms is a well-known problem in the field of mechanical engineering because the variable dynamic loads cause vibrations, as well as noise, wear and fatigue of the machines. A mechanical system with unbalance shaking force and shaking moment transmits substantial vibration to the frame. Therefore, the objective of the balancing is to cancel or reduce the variable dynamic reactions transmitted to the frame. The resolution of this problem consists in the balancing of the shaking force and shaking moment. It can be fully or partially, by internal mass redistribution via adding counterweights or by modification of the mechanism's architecture via adding auxiliary structures. The balancing problems are of continue interest to researchers. Several laboratories around the world are very active in this area and new results are published regularly. However, despite its ancient history, mechanism balancing theory continues to be developed and new approaches and solutions are constantly being reported. Various surveys have been published that disclose particularities of balancing methods. The author believes that this is an appropriate moment to present a state of the art of the shaking force balancing studies completed by new research results. This paper presents an overview of methods devoted to the shaking force balancing of mechanisms, as well as the historical aspects of the origins and the evolution of the balancing theory of mechanisms.