A large international life sciences manufacturer had initiated a Part 11 compliance program for their organization. This program is mission critical: non-compliance can trigger a multitude of FDA citations including a slow-down or halt to the review process of the drugs they have in development, thus slowing their time to...
A flexible methodology for planning of complex energy service systems with multiple energy carriers is presented. The methodology includes technical, economic and environmental aspects, and will enable public and corporate decision makers to carry out comprehensive analyses of energy supply systems with respect to investments, environmental impacts and consequences of...
The value returned by Enterprise Architecture EA is increasingly under consideration by researchers and practitioners. They struggle to justify the EA investments made. Quantifying the Enterprise Architecture benefits has always been a challenge because measurements and real value delivered can not often be expressed in simple technical oriented metrics only....
This paper provides a revised measure of regulatory restrictions on inward Foreign Direct Investment FDI for OECD (Organisation for Economic Co-operation and Development) countries and extends the approach to 13 non-member countries. The methodology is largely similar to that adopted in the previous version of the OECD indicator and covers...
There are advantages as well as disadvantages of all methodologies. For each particular selection process, there is one of these methodologies that are best suited for the selection process. There is also the question, whether Enterprise Resource Planning ERP system will actually fulfil all the needs will never remain entirely...
In this paper, the authors formulate a time-scale decomposition of an international version of the CAPM that accounts for both market and exchange-rate risk. In addition, an analytical formula is derived for time-scale value at risk and marginal Value at Risk VaR of a portfolio. The methodology is applied to...
A methodology for designing data center infrastructure for E-commerce sites is developed. It differs from existing methodologies in that it evaluates and compares alternative designs from a business perspective, that is, by evaluating the business impact financial loss imposed by imperfect infrastructure. The methodology provides the optimal infrastructure that minimizes...
Architecture, Engineering, and Construction AEC projects require multidisciplinary solutions. AEC professionals have formal methods to help them manage and communicate much of a single discipline's information; however, they lack formal methodologies to manage and communicate information and processes among multiple disciplines. The authors are designing and implementing three methodologies to...
This paper outlines a way to estimate transition matrices for use in credit risk modeling with a decades-old methodology that uses aggregate proportions data. This methodology is ideal for credit-risk applications where there is a paucity of data on changes in credit quality, especially at an aggregate level. Using a...
Decision-making in the field of academic planning involves extensive analysis of large data volumes originating from multiple systems. Academic workload management is concerned with distributing teaching resources in order to adequately support the university's educational framework (faculties, degrees, courses, admission policies, teaching workload etc). A methodology is proposed for assessing...
Any outside consultancy will usually add value to your team's efforts by bringing an independent perspective to your project. Superior methodology brings more value, but good methodology does not overcome lack of experience. When a project warrants bringing in a consultancy, be sure you engage with one that offers a...
This paper tests for productivity gains resulting from the introduction of a productivity-based incentive program in a large manufacturing plant of a Fortune 500 corporation. A methodology is developed based on a stochastic nonparametric frontier estimation technique to evaluate productivity in the postincentive plan period relative to the pre-incentive plan...
This paper develops a methodology for decomposing cross-country variation in export unit values into quality versus real price components. The methodology is based on revealed preferences in an environment where consumers have a taste for variety. The authors have derived conditions under which the unobserved export quality ratio of any...
Biotech startups do not always have adequate plans for GMP documentation. Key issues typically overlooked include resource requirements, routing pathways, approval procedures, and how the documentation plan relates to the overall project plan. This article provides guidelines, tools, and recommendations on managing GMP documentation requirements to support the startup of...
A comprehensive approach to quality goal setting is presented that is consistent with Motorola's six-sigma metric development. In particular, process mean shifts are determined and incorporated into the goal setting process. Methodology includes basic probability theory, statistical control charts, and capability indices. Data for an aircraft part consisting of hundreds...
This paper briefly introduces the transition theory underlying the work in this Hysociety work-package, then turn to the methodology that was developed to be able to analyze both the country-specific and boundary-crossing challenges to conclude with a discussion of some results. The methodology explicitly focused on the relevant challenges to...
The main objective of this paper was to use the methodology developed in the previous FES project (K/EL/00287 Extension) to assess the security capability of modern distributed generation. The agreed deliverables of this paper were prototype software using the agreed methodology that could be used by relevant parties for evaluating...
This paper studies the "overpriced puts puzzle" - the finding that historical prices of the S&P 500 put options have been too high and incompatible with the canonical asset-pricing models. Simple trading strategies that involve selling at-the-money and out-of-the-money puts would have earned extraordinary profits. To investigate whether put returns...
Digital Signal Processing techniques constitute the basic scientific approach used in most of the current advances in medicine. In particular, the development of algorithms in order to extract, predict and model raw biomedical data series has revolutionized many routine, but data-intensive, areas of current medical practice. This paper presents an...
This paper presents a methodology for Data Warehouse design and its application within the TELECOM ITALIA information system. The methodology is based on a conceptual representation of the Enterprise, which is exploited both in the integration phase of the Warehouse information sources and during the knowledge discovery activity on the...
