THE INTERNAL AUDITORS OF PHARMACEUTICAL QUALITY SYSTEMS COMPETENCE IMPROVING

The importance of internal audits for the pharmaceutical company, which is indicated in the guidelines for good practices in pharmacy (in particular, GMP, GDP). The issue of selection, training, grading, certification and continuous improvement of the auditor’s competence at pharmaceutical companies are relevant and important both for domestic ones, and for foreign enterprises. The aim of the study was to determine the competence of the pharmacy quality system internal auditors’ and the areas of its development. Materials and methods. The object of the study was the competence of internal auditors of pharmaceutical quality systems. Empirical and theoretical research methods were used, in particular the method of comparative analysis of scientific literature in the field of research, the method of structural and logical modeling. The information basis was the provisions of regulations and materials published in the open professional scientific literature. Results. The competence of quality management system auditors in general and pharmaceutical quality system in particular consists of personal qualities, professional knowledge and skills. The ISO 19011 standard highlights the importance of evaluating and continuous development of auditors’ competence. Such an assessment should take into account the needs of the audit program and its objectives. Areas of development of auditors' competence should be determined by the specifics of industry activities. This provision of the standard should be considered relevant for pharmaceutical companies. Conclusions. We studied the requirements for the competence of QMS internal auditors of international and industry standards. A review of the regulatory framework showed a lack of information on the chosen area of the research. Defined requirements for the competence of the PQM audits staff assists the selection of specialists to the audit team so that the overall competence of the audit team is sufficient to achieve the objectives of the audit

Closing the gap between software engineering education and industrial needs

According to different reports, many recent software engineering graduates often face difficulties when beginning their professional careers, due to misalignment of the skills learnt in their university education with what is needed in industry. To address that need, many studies have been conducted to align software engineering education with industry needs. To synthesize that body of knowledge, we present in this paper a systematic literature review (SLR) which summarizes the findings of 33 studies in this area. By doing a meta-analysis of all those studies and using data from 12 countries and over 4,000 data points, this study will enable educators and hiring managers to adapt their education / hiring efforts to best prepare the software engineering workforce

The economics of accreditation

This paper is a report on a research project on the economics of accreditation in the UK. The main motivation and objective for the study is to have available a detailed analysis of how the accreditation system impinges on important aspects of economic life, such as innovation and business and economic performance. It aims to improve the general understanding of the benefits of using accredited conformity assessment and to help businesses make informed decisions when procuring conformity assessment and related services. It is also intended to be helpful to government by supporting evidence-based policy making in relation to accreditation and conformity assessmen

Impact of airline service quality on overall and female passengers' satisfaction : a case study of Tonga's domestic aviation market : a 190.893 (120 credit) research report presented in partial fulfilment of the requirements for the degree of Master of Aviation at Massey University, Palmerston North, New Zealand

The primary objectives of this thesis are to determine the direct impact of airline service quality on passengers’ satisfaction in Tonga’s domestic aviation market. The determinants of airline service quality were identified by using the SERVQUAL dimensions (assurance, empathy, reliability, responsiveness and tangibles) as measurable indicators. A survey was conducted and 205 questionnaires were collected and analysed. Empirical results obtained via the structural equation modelling (SEM) approach revealed that airline service quality has a direct impact on overall and female passengers’ satisfaction. Furthermore, both overall and female passengers were mostly satisfied with the responsiveness dimension. The tangibles dimension was the dimension with the lowest level of satisfaction for overall passengers and the reliability dimension was the dimension with the lowest satisfaction for female passengers. Importantly, the research highlights the different levels of satisfaction among airline passengers in the monopolistic Tongan domestic aviation market. The findings have implications for the airline management

Sustainable Value Proposition Design in a Product-Service System

Many companies have started to add services to their tangible products in order to defend themselves from increased competition from low-cost economies. Research regarding the transition towards product-service systems (PSS) and how the PSS providers' business models are affected exists, but there is a lack of research regarding how the suppliers to the PSS providers are affected by the transition towards PSS. Therefore, this thesis studies the situation for a supplier/partner to an OEM that has changed their business model to a PSS providing one. As the first step in a development of a new business model aims this thesis to provide guidelines for how to set up value propositions suitable for a supplier/partner in this new environment. When technologically complex products, such as aircraft engines, are provided through PSS offerings it is hard to translate customer needs into quality parameters, which makes it hard to sustain the value to customer over time. Therefore, how to keep the value offering sustainable over time is also investigated in this thesis. The aim of this study was to investigate how a sustainable value proposition can be designed for a product and technology supplier/partner to an OEM that offers PSS solutions. The research has been performed through studying relevant literature and collecting empirical data from a case company through semi-structured interviews and a workshop. The case company in this research is Volvo Aero Corporation (VAC). The empirical findings show that VAC wants to offer product-service bundled solution, which fit the whole spectra of PSS value propositions, to their partners/customers. To be able to deliver these different types of product-service bundled solutions different value propositions that suit the different kinds of PSS offerings are needed. Requirements that must be fulfilled to be able to offer and deliver the different types of value propositions exist in terms of securing sufficient information access, aligning the incentives of all actors involved and achieving an internal consensus of what is delivered

Structured approach to measure performance in construction research and development: performance measurement system development

Purpose of this paper: This study explore Performance Measurement applications within construction research and development (R\&D) to develop a structured approach to measure the performance of collaborative construction R\&D projects during its lifecycle from initiation, conceptualising, development and launch stages and at the project management. Design/methodology/approach: During the exploratory phase of the study, semi-structured interviews and a questionnaire survey were carried out to develop the performance measurement system (PMS). During the explanatory phase, the developed PMS was refined with a series of semi-structured interviews. The data was gathered from principal investigators, researchers and industrial partners involved in collaborative construction R\&D work. Findings: Main finding is the developed PMS to measure the performance of construction R\&D that consists of critical success factors, performance indicators and performance measures during the lifecycle of a R\&D project. Practical implications: The PMS developed through the study provides critical success factors, performance indicators and measures that need to be considered during the construction R\&D projects to measure the performance. Thus, through the implementation of the PMS, this study contributes to practice by assisting the performance improvement within construction R\&D projects. What is original / value of paper?: The developed PMS to measure the performance of construction R\&D project will provide value for those who are engaged in R\&D work (Principle investigators, researcher and industrial partners) to ensure the success of their projects

How do software architects consider non-functional requirements: an exploratory study

© 2012 IEEE. Personal use of this material is permitted. Permission from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertising or promotional purposes,creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other works.Dealing with non-functional requirements (NFRs) has posed a challenge onto software engineers for many years. Over the years, many methods and techniques have been proposed to improve their elicitation, documentation, and validation. Knowing more about the state of the practice on these topics may benefit both practitioners' and researchers' daily work. A few empirical studies have been conducted in the past, but none under the perspective of software architects, in spite of the great influence that NFRs have on daily architects' practices. This paper presents some of the findings of an empirical study based on 13 interviews with software architects. It addresses questions such as: who decides the NFRs, what types of NFRs matter to architects, how are NFRs documented, and how are NFRs validated. The results are contextualized with existing previous work.Peer ReviewedPostprint (author’s final draft

The other GMP: good manufacturing practice and its importance in the validation of constructed pharmaceutical facilities

The work reported is part of an ongoing PhD study prompted by the particular difficulties encountered when two very different quality cultures interact (in this case Pharmaceutical industry clients and Construction industry providers). Pharmaceutical facilities have particular needs for their production requirements. Stringent regulations are set by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) (in the UK) and the Food and Drugs Administration (FDA) in the US. This creates special problems of quality when it comes to the commissioning, validation and hand-over of the building, as it appears to be at odds with the rather less demanding quality systems that are normally accepted in the construction sector. The aim of the research is to model an acceptable process for incorporating these stringent validation requirements into the design, procurement and construction processes. There is little or no specific academic literature on the subject, though the trades and professional press (particularly in the USA) provide some normative comment on the problem area. The main academic grounding of the research is in Systems Theory and empirical data is being collecting using a multiple case study approach. Research data was collected from a number of pharmaceutical facility construction case studies and was used to test and inform a best practice model of facility validation. The qualitative methods of participant and direct observation were used as the main information gathering tools. The paper reports on the regulatory expectations that influence the construction of projects of this type and the impact on the best practice model of validation

Implementation of critical success factors in construction research and development process

Construction research and development (R&D) process has a number of issues that affect its success. These issues imply that Critical Success Factors (CSFs) of construction R&D process are not properly addressed. Not knowing CSFs could lead to not implementing them and not paying proper attention for them. The study investigates CSFs of construction R&D process and their implementation/consideration during the R&D process. A comprehensive literature review was used first to develop construction R&D process. CSFs and their implementation/consideration were evaluated by a questionnaire survey. Construction R&D process was derived with four phases namely Initiation, Conceptualizing, Development and Launch and Management activities that support coordination and resourcing of R&D process. Study revealed that, as a whole there is a gap between the importance of success factors against their implementation/consideration as majority of CSFs are not properly implemented compared to the importance attached to them. Keywords: Construction R&D process, Critical success factors, Implementation, Consideratio