Support Tool to the Validation Process of Functional Requirements

The activity of validating identified requirements for an information system helps to improve the quality of a requirements specification document and, consequently, the success of a project. Although various different support tools to requirements engineering exist in the market, there is still a lack of automated support for validation activity. In this context, the purpose of this paper is to make up for that deficiency, with the use of an automated tool, to provide the resources for the execution of an adequate validation activity. The contribution of this study is to enable an agile and effective follow-up of the scope established for the requirements, so as to lead the development to a solution which would satisfy the real necessities of the users, as well as to supply project managers with relevant information about the maturity of the analysts involved in requirements specification.

Support Tool to the Validation Process of Functional Requirements

The activity of validating identified requirements for an information system helps to improve the quality of a requirements specification document and, consequently, the success of a project. Although various different support tools to requirements engineering exist in the market, there is still a lack of automated support for validation activity. In this context, the purpose of this paper is to make up for that deficiency, with the use of an automated tool, to provide the resources for the execution of an adequate validation activity. The contribution of this study is to enable an agile and effective follow-up of the scope established for the requirements, so as to lead the development to a solution which would satisfy the real necessities of the users, as well as to supply project managers with relevant information about the maturity of the analysts involved in requirements specification.

Conceptual-physical bridging – From BPMN models to physical implementations on kettle

Developing and implementing data-oriented workflows for data migration processes are complex tasks involving several problems related to the integration of data coming from different schemas. Usually, they involve very specific requirements - every process is almost unique. Having a way to abstract their representation will help us to better understand and validate them with business users, which is a crucial step for requirements validation. In this demo we present an approach that provides a way to enrich incrementally conceptual models in order to support an automatic way for producing their correspondent physical implementation. In this demo we will show how B2K (Business to Kettle) system works transforming BPMN 2.0 conceptual models into Kettle data-integration executable processes, approaching the most relevant aspects related to model design and enrichment, model to system transformation, and system execution.

Validação de instrumentos para avaliação da habilidade e do conhecimento acerca da medida da pressão arterial

This study aimed to validate tools for evaluating the ability and knowledge about blood pressure (BP) among nursing students. It is a cross-sectional, descriptive, quantitative and methodological study accomplished at the Universidade Federal do Rio Grande do Norte (UFRN), Universidade do Estado do Rio Grande do Norte (UERN) and a private university of the state. The sample consisted of 27 judges of research selected from the inclusion criteria: nursing, teachers of the semiology and/or semiotics discipline, with at least 1 year of experience, being from UFRN, EEN, UERN and private university of the state and and agree to participate voluntarily with the signing of the consent form. The research was development in three stages: construction of two instruments based on the scientific literature, resulting in a structured checklist consists of 28 items and a knowledge questionnaire with 12 questions; submission of the instruments to the judges, in the period from June to September 2012, which should evaluate each item in appropriate , appropriate with changes and inappropriate , addition to making an overall assessment of each instrument based on 10 requirements; validation and verification to the level of agreement among the judges, through the application of Kappa and Content Validity Index (CVI). Was used the consensus level greater than 0.61 (good) to the Kappa index and greater than 0.75 for CVI. Was approved by the Ethics in Research / HUOL. After being coded and tabulated, the data were analyzed using descriptive statistics. Of the 27 judges who evaluated the instrument, 77.8% are female, with a mean age of 36.6 (± 9.0) years, 63.0% worked in UFRN, 74.1% had academic master and 63.0% worked exclusively on teaching. Average length of teaching experience was 7.9 (± 8.0) years and in the semiology and/or semiotics discipline of 5.5 (± 6.7) years. In the judgment of structured checklist and questionnaire of knowledge about blood pressure mensurement any item/question was considered inappropriate since all obtained level of agreement within the indices established (CVI> 0,75 E Kappa> 0.61). In relation to structured checklist, of those 28 items present, 9 showed perfect concordance index (CVI = 1.00, Kappa = 1.00) and another 19 were considered appropriate with changes, especially with regard to clarity and vocabulary. In the questionnaire of knowledge, among the 12 questions that comprised, 7 had perfect concordance index and the others were considered appropriate with changes as requirements as clarity, vocabulary, and feasible sequence of instructional topics. In terms of a overall evaluating of instruments, the structured checklist got CVI of 0.94 and Kappa of 0.89 and the knowledge questionnaire, CVI of 0.97 and a kappa of 0.94. Both instruments proved to be valid as to their content, configuring it as clear and objective tools of assessment of knowledge and ability on blood pressure, being of nursing students as well as others students and health professionals, since the use of valid measures seeking to reduce the risk of distorting the results

The validation of predictions concerning personnel and training requirements: a case study

"References": leaves 26-27.

Process Capability Indexes Determination on Tabletting Performance during the Process Validation for Metamizol Tablets

The aim of the present study was to provide a numerical measure, through the process capability indexes (PCIs), C(p) and C(pk), on whether or not the manufacturing process can be considered capable of producing metamizol (500 mg) tablets. They were also used as statistical tool in order to prove the consistency of the tabletting process, making sure that the tablet weight and the content uniformity of metamizol are able to comply with the preset requirements. Besides that, the ANOVA, the t-test and the test for equal variances were applied to this study, allowing additional knowledge of the tabletting phase. Therefore, the proposed statistical approach intended to assure more safety, precision and accuracy on the process validation analysis.

From design-for-test to design-for-debug-and-test: analysis of requirements and limitations for 1149.1

The increasing complexity of VLSI circuits and the reduced accessibility of modern packaging and mounting technologies restrict the usefulness of conventional in-circuit debugging tools, such as in-circuit emulators for microprocessors and microcontrollers. However, this same trend enables the development of more complex products, which in turn require more powerful debugging tools. These conflicting demands could be met if the standard scan test infrastructures now common in most complex components were able to match the debugging requirements of design verification and prototype validation. This paper analyses the main debug requirements in the design of microprocessor-based applications and the feasibility of their implementation using the mandatory, optional and additional operating modes of the standard IEEE 1149.1 test infrastructure.

Design and validation of a biomechanical bioreactor for cartilage tissue culture

Specific tissues, such as cartilage undergo mechanical solicitation under their normal performance in human body. In this sense, it seems necessary that proper tissue engineering strategies of these tissues should incorporate mechanical solicitations during cell culture, in order to properly evaluate the influence of the mechanical stimulus. This work reports on a user-friendly bioreactor suitable for applying controlled mechanical stimulation - amplitude and frequency - to three dimensional scaffolds. Its design and main components are described, as well as its operation characteristics. The modular design allows easy cleaning and operating under laminar hood. Different protocols for the sterilization of the hermetic enclosure are tested and ensure lack of observable contaminations, complying with the requirements to be used for cell culture. The cell viability study was performed with KUM5 cells.

Characterisation of neutron spectra in mixed high energy fields in lineal accelerators: response functions validation

Actualment, la resposta de la majoria d’instrumentació operacional i dels dosímetres personals utilitzats en radioprotecció per a la dosimetria neutrònica és altament dependent de l’energia dels espectres neutrònics a analitzar, especialment amb camps neutrònics amb una important component intermitja. En conseqüència, la interpretació de les lectures d’aquests aparells es complicada si no es té un coneixement previ de la distribució espectral de la fluència neutrònica en els punts d’interès. El Grup de Física de les Radiacions de la Universitat Autònoma de Barcelona (GFR-UAB) ha desenvolupat en els últims anys un espectròmetre de neutrons basat en un Sistema d’Esferes Bonner (BSS) amb un contador proporcional d’3He com a detector actiu. Els principals avantatges dels espectròmetres de neutrons per BSS són: la seva resposta isotròpica, la possibilitat de discriminar la component neutrònica de la gamma en camps mixtos, i la seva alta sensibilitat neutrònica als nivells de dosi analitzats. Amb aquestes característiques, els espectròmetres neutrònics per BSS compleixen amb els estándards de les últimes recomanacions de la ICRP i poden ser utilitzats també en el camp de la dosimetria neutrònica per a la mesura de dosis en el rang d’energia que va dels tèrmics fins als 20 MeV, en nou ordres de magnitud. En el marc de la col•laboració entre el GFR - UAB i el Laboratorio Nazionale di Frascati – Istituto Nazionale di Fisica Nucleare (LNF-INFN), ha tingut lloc una experiència comparativa d’espectrometria per BSS amb els feixos quasi monoenergètics de 2.5 MeV i 14 MeV del Fast Neutron Generator de l’ENEA. En l’exercici s’ha determinat l’espectre neutrònic a diferents distàncies del blanc de l’accelerador, aprofitant el codi FRUIT recentment desenvolupat pel grup LNF. Els resultats obtinguts mostren una bona coherència entre els dos espectròmetres i les dades mesurades i simulades.

The implementation of liquid chromatography tandem mass spectrometry for the official control of lipophilic toxins in seafood: Single-laboratory validation under four chromatographic conditions

We performed a comprehensive study to assess the fit for purpose of four chromatographic conditions for the determination of six groups of marine lipophilic toxins (okadaic acid and dinophysistoxins, pectenotoxins, azaspiracids, yessotoxins, gymnodimine and spirolides) by LC-MS/MS to select the most suitable conditions as stated by the European Union Reference Laboratory for Marine Biotoxins (EURLMB). For every case, the elution gradient has been optimized to achieve a total run-time cycle of 12 min. We performed a single-laboratory validation for the analysis of three relevant matrices for the seafood aquaculture industry (mussels, pacific oysters and clams), and for sea urchins for which no data about lipophilic toxins have been reported before. Moreover, we have compared the method performance under alkaline conditions using two quantification strategies: the external standard calibration (EXS) and the matrix-matched standard calibration (MMS). Alkaline conditions were the only scenario that allowed detection windows with polarity switching in a 3200 QTrap mass spectrometer, thus the analysis of all toxins can be accomplished in a single run, increasing sample throughput. The limits of quantification under alkaline conditions met the validation requirements established by the EURLMB for all toxins and matrices, while the remaining conditions failed in some cases. The accuracy of the method and the matrix effects where generally dependent on the mobile phases and the seafood species. The MMS had a moderate positive impact on method accuracy for crude extracts, but it showed poor trueness for seafood species other than mussels when analyzing hydrolyzed extracts. Alkaline conditions with EXS and recovery correction for OA were selected as the most proper conditions in the context of our laboratory. This comparative study can help other laboratories to choose the best conditions for the implementation of LC-MS/MS according to their own necessities.

Minimum requirements for application of ink dating methods based on solvent analysis in casework

Several ink dating methods based on solvents analysis using gas chromatography/mass spectrometry (GC/MS) were proposed in the last decades. These methods follow the drying of solvents from ballpoint pen inks on paper and seem very promising. However, several questions arose over the last few years among questioned documents examiners regarding the transparency and reproducibility of the proposed techniques. These questions should be carefully studied for accurate and ethical application of this methodology in casework. Inspired by a real investigation involving ink dating, the present paper discusses this particular issue throughout four main topics: aging processes, dating methods, validation procedures and data interpretation. This work presents a wide picture of the ink dating field, warns about potential shortcomings and also proposes some solutions to avoid reporting errors in court.

Benchmarked Quality Measurement Process in a Software Validation Process

Jatkuva laadunmittaus osana ohjelmistoprosessia on yleistynyt ohjelmistoyritysten keskuudessa viime vuosien aikana. ISO 9001:2000 -laatustandardi vaatii yrityksiltä tuotteiden ja prosessien laadun mittaamista ja seuraamista. Laadun mittareiden valinta on haastava tehtävä. Yritykset luulevat usein mittaavansa laatua, vaikka ne todellisuudessa mittaavatkin ohjelmistojen eri ominaisuuksia kuten kokoa tai monimutkaisuutta. Tässä diplomityössä kehitetään ohjelmistojen validointiprosessiin vertailuun perustuva laadunmittausprosessi ohjelmistotuotteiden laadun arviointiin, mittaamiseen ja seurantaan. Laatumittarit valitaan ennalta määriteltyjen kriteereiden mukaisesti, ja niille asetetaan tavoitearvot vertailuanalyysistä saatujen tulosten perusteella. Laadunmittausprosessin lisäksi työssä annetaan suositus prosessin käyttöönotosta ja käytöstä osana yrityksen toimintaa, mikä mahdollistaa jatkuvan seurannan sekä kehityksen tulevaisuudessa.

Improving Evaluation and Development Capability in Verification and Validation

Validation and verification operations encounter various challenges in product development process. Requirements for increasing the development cycle pace set new requests for component development process. Verification and validation usually represent the largest activities, up to 40 50 % of R&D resources utilized. This research studies validation and verification as part of case company's component development process. The target is to define framework that can be used in improvement of the validation and verification capability evaluation and development in display module development projects. Validation and verification definition and background is studied in this research. Additionally, theories such as project management, system, organisational learning and causality is studied. Framework and key findings of this research are presented. Feedback system according of the framework is defined and implemented to the case company. This research is divided to the theory and empirical parts. Theory part is conducted in literature review. Empirical part is done in case study. Constructive methode and design research methode are used in this research A framework for capability evaluation and development was defined and developed as result of this research. Key findings of this study were that double loop learning approach with validation and verification V+ model enables defining a feedback reporting solution. Additional results, some minor changes in validation and verification process were proposed. There are a few concerns expressed on the results on validity and reliability of this study. The most important one was the selected research method and the selected model itself. The final state can be normative, the researcher may set study results before the actual study and in the initial state, the researcher may describe expectations for the study. Finally reliability of this study, and validity of this work are studied.

Development and validation of spectroscopic methods for simultaneous estimation and dissolution of ofloxacin and ornidazole in tablet dosage forms

The aim of this work was to develop and validate simple, accurate and precise spectroscopic methods (multicomponent, dual wavelength and simultaneous equations) for the simultaneous estimation and dissolution testing of ofloxacin and ornidazole tablet dosage forms. The medium of dissolution used was 900 ml of 0.01N HCl, using a paddle apparatus at a stirring rate of 50 rpm. The drug release was evaluated by developed and validated spectroscopic methods. Ofloxacin and ornidazole showed 293.4 and 319.6nm as λmax in 0.01N HCl. The methods were validated to meet requirements for a global regulatory filing. The validation included linearity, precision and accuracy. In addition, recovery studies and dissolution studies of three different tablets were compared and the results obtained show no significant difference among products.

Requirements management process

Vaatimustenhallinnan alue on hyvin kompleksinen. Sen terminologia on moninaista ja samat termit voivat tarkoittaa eri asioita eri ihmisille. Tämän työn tarkoituksena on selkeyttää vaatimustenhallinnan aluetta. Se vastaa kysymyksiin kuten, mitä vaatimustenhallinta on ja miten sitä voidaan tehdä. Työ keskittyy vaatimusten analysoinnin ja validoinnin alueisiin, joten tältä osin se vastaa myös tarkempiin kysymyksiin kuten, miten koottujen vaatimusten jäljitettävyyttä, dokumentointia, analysointia ja validointia voidaan tehdä. Tämän työn kautta vaatimustenhallinta voidaan esitellä yritykselle ja sen eri osat voivat saada saman käsityksen vaatimustenhallinnasta. Tutkimus esittelee vaatimustenhallinnan prosessina, joka pitää sisällään vaatimusten jäljitettävyyden, vaatimusten dokumentoinnin, vaatimusten muutoksenhallinnan ja vaatimusmäärityksen. Vaatimusmääritys voidaan edelleen jakaa vaatimusten koostamiseen, analysointiin ja neuvotteluun sekä validointiin. Työssä esitellään geneerinen vaatimustenhallinnan prosessimalli. Mallin avulla näytetään, että vaatimustenhallinta on jatkuva prosessi, jossa kaikki aktiviteetit ovat kytköksissä toisiinsa. Näitä aktiviteettejä suoritetaan enemmän tai vähemmän samanaikaisesti. Malli esitetään geneerisessä muodossa, jotta se olisi hyödynnettävissä systeemi- ja tuotekehitys projekteissa sekä sisäisissä kehitysprojekteissa. Se kertoo, että vaatimukset tulisi jalostaa niin aikaisin, kuin mahdollista, jotta muutoksien määrä kehitystyön myöhemmissä vaiheissa voitaisiin minimoida. Jotkin muutokset eivät ole vältettävissä, joten muutoksenhallinnan tueksi tulisi kehittää jäljitettävyyskäsikirja ja jäljitettävyyskäytännöt. Vaatimustenhallintaa tarkastellaan meneillään olevassa kehitysprojektissa. Tarkastelussa tutkitaan, mitä vaatimustenhallinnan toimintatapoja sekä analysointi- ja validointimetodeja käytetään ja mitä voitaisiin tehdä vaatimustenhallinnan parantamiseksi projektissa.