953 resultados para Safety-critical software


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PURPOSE: Many rectal cancer patients undergo abdominoperineal excision worldwide every year. Various procedures to restore perineal (pseudo-) continence, referred to as total anorectal reconstruction, have been proposed. The best technique, however, has not yet been defined. In this study, the different reconstruction techniques with regard to morbidity, functional outcome and quality of life were analysed. Technical and timing issues (i.e. whether the definitive procedure should be performed synchronously or be delayed), oncological safety, economical aspects as well as possible future improvements are further discussed. METHODS: A MEDLINE and EMBASE search was conducted to identify the pertinent multilingual literature between 1989 and 2013. All publications meeting the defined inclusion/exclusion criteria were eligible for analysis. RESULTS: Dynamic graciloplasty, artificial bowel sphincter, circular smooth muscle cuff or gluteoplasty result in median resting and squeezing neo-anal pressures that equate to the measurements found in incontinent patients. However, quality of life was generally stated to be good by patients who had undergone the procedures, despite imperfect continence, faecal evacuation problems and a considerable associated morbidity. Many patients developed an alternative perception for the urge to defecate that decisively improved functional outcome. Theoretical calculations suggested cost-effectiveness of total anorectal reconstruction compared well to life with a permanent colostomy. CONCLUSIONS: Many patients would be highly motivated to have their abdominal replaced by a functional perineal colostomy. Given the considerable morbidity and questionable functional outcome of current reconstruction technique improvements are required. Tissue engineering might be an option to design an anatomically and physiologically matured, and customised continence organ.

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Cloudification of the Centralized-Radio Access Network (C-RAN) in which signal processing runs on general purpose processors inside virtual machines has lately received significant attention. Due to short deadlines in the LTE Frequency Division Duplex access method, processing time fluctuations introduced by the virtualization process have a deep impact on C-RAN performance. This paper evaluates bottlenecks of the OpenAirInterface (OAI is an open-source software-based implementation of LTE) cloud performance, provides feasibility studies on C-RAN execution, and introduces a cloud architecture that significantly reduces the encountered execution problems. In typical cloud environments, the OAI processing time deadlines cannot be guaranteed. Our proposed cloud architecture shows good characteristics for the OAI cloud execution. As an example, in our setup more than 99.5% processed LTE subframes reach reasonable processing deadlines close to performance of a dedicated machine.

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BACKGROUND Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation. OBJECTIVES The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI). METHODS Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR. RESULTS Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080). CONCLUSIONS In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).

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OBJECTIVES: To (1) review the development and medical applications of hydroxyethyl starch (HES) solutions with particular emphasis on its physiochemical properties; (2) critically appraise the available evidence in human and veterinary medicine, and (3) evaluate the potential risks and benefits associated with their use in critically ill small animals. DATA SOURCES: Human and veterinary original research articles, scientific reviews, and textbook sources from 1950 to the present. HUMAN DATA SYNTHESIS: HES solutions have been used extensively in people for over 30 years and ever since its introduction there has been a great deal of debate over its safety and efficacy. Recently, results of seminal trials and meta-analyses showing increased risks related to kidney dysfunction and mortality in septic and critically ill patients, have led to the restriction of HES use in these patient populations by European regulatory authorities. Although the initial ban on the use of HES in Europe has been eased, proof regarding the benefits and safety profile of HES in trauma and surgical patient populations has been requested by these same European regulatory authorities. VETERINARY DATA SYNTHESIS: The veterinary literature is limited mostly to experimental studies and clinical investigations with small populations of patients with short-term end points and there is insufficient evidence to generate recommendations. CONCLUSIONS: Currently, there are no consensus recommendations regarding the use of HES in veterinary medicine. Veterinarians and institutions affected by the HES restrictions have had to critically reassess the risks and benefits related to HES usage based on the available information and sometimes adapt their procedures and policies based on their reassessment. Meanwhile, large, prospective, randomized veterinary studies evaluating HES use are needed to achieve relevant levels of evidence to enable formulation of specific veterinary guidelines.

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In hemodialysis patients, radiographic imaging with iodinated contrast medium (ICM) application plays a central role in the diagnosis and/or follow-up of disease-related conditions. Therefore, safety aspects concerning ICM administration and radiation exposure have a great impact on this group of patients. Current hardware and software improvements including the design and synthesis of modern contrast compounds allow the use of very small amounts of ICM in concert with low radiation exposure. Undesirable ICM side effects are divided into type A (predictable reactions such as heat feeling, headache, and contrast-induced acute kidney injury, for example) and type B (nonpredictable or hypersensitivity) reactions; this chapter deals with the latter. The first onset cannot be prevented. To prevent hypersensitivity upon reexposure of ICM, an allergological workup is recommended. If this is not possible and ICM is necessary, the patient should receive a premedication (H1 antihistamine with or without corticosteroids). Current imaging hardware and software improvements (e.g. such as additional filtration of the X-ray beam) allow the use of very small amount of ICM and small X-ray doses. Proper communication among the team involved in the treatment of a patient may allow to apply imaging protocols and efficient imaging strategies limiting radiation exposure to a minimum. Practical recommendations will guide the reader how to use radiation and ICM efficiently to improve both patient and staff safety.

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Errors in healthcare are commonplace and have significant impact on mortality, morbidity, and costs. Other high-risk industries are credited with strong safety records. These successes are due in part to a strong, committed organizational culture and their leadership. A consistent pattern of effective leadership behaviors; creating change, establishing a vision and strategic actions, and enabling and inspiring the organization's members to act, is present in these high-risk industries. This research examined the relationship between leadership practices and a medication safety regime. The hypothesis is strong leadership practices have a positive relationship with the degree of sophistication of a medication safety program (safety performance). Leadership was used as a surrogate for organizational culture and was measured in this research through the Kouzes and Posner's Leadership Practices Inventory. The Institute of Medicine's 14 Selected Strategies to Improve Medication Safety was used to measure the development of a medication safety regime. Leadership practices towards safety were assessed by surveying 2,478 critical care Registered Nurses in the greater Houston area. A response rate of 19% was achieved. Thirteen hospitals participated in the medication safety regime assessment. Data from 386 RN respondents from 53 institutions provided an overall description of unit (ICU) and organization (hospital) leader's practices towards safety. There is some recognition of the medical error problem and that leaders exhibit moderate levels of leadership practices to promote safety. There were no differences noted in unit and hospital leaders' behaviors, with the exception that unit leaders promote change and enable staff to act more often than hospital leaders. There were no statistically significant relationships between overall leadership, or individual leadership practices and the organization's safety performance. There was a significant relationship between leadership and safety performance when other factors in organizational culture were considered. Teaching and Magnet hospitals also exhibited stronger behaviors towards safety. Organizational culture, as measured by academic affiliation and Magnet recognition, is strongly related to safety performance as measured by the degree of development of a medication safety regime. ^

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Introduction. Selectively manned units have a long, international history, both military and civilian. Some examples include SWAT teams, firefighters, the FBI, the DEA, the CIA, and military Special Operations. These special duty operators are individuals who perform a highly skilled and dangerous job in a unique environment. A significant amount of money is spent by the Department of Defense (DoD) and other federal agencies to recruit, select, train, equip and support these operators. When a critical incident or significant life event occurs, that jeopardizes an operator's performance; there can be heavy losses in terms of training, time, money, and potentially, lives. In order to limit the number of critical incidents, selection processes have been developed over time to “select out” those individuals most likely to perform below desired performance standards under pressure or stress and to "select in" those with the "right stuff". This study is part of a larger program evaluation to assess markers that identify whether a person will fail under the stresses in a selectively manned unit. The primary question of the study is whether there are indicators in the selection process that signify potential negative performance at a later date. ^ Methods. The population being studied included applicants to a selectively manned DoD organization between 1993 and 2001 as part of a unit assessment and selection process (A&S). Approximately 1900 A&S records were included in the analysis. Over this nine year period, seventy-two individuals were determined to have had a critical incident. A critical incident can come in the form of problems with the law, personal, behavioral or family problems, integrity issues, and skills deficit. Of the seventy-two individuals, fifty-four of these had full assessment data and subsequent supervisor performance ratings which assessed how an individual performed while on the job. This group was compared across a variety of variables including demographics and psychometric testing with a group of 178 individuals who did not have a critical incident and had been determined to be good performers with positive ratings by their supervisors.^ Results. In approximately 2004, an online pre-screen survey was developed in the hopes of preselecting out those individuals with items that would potentially make them ineligible for selection to this organization. This survey has aided the organization to increase its selection rates and save resources in the process. (Patterson, Howard Smith, & Fisher, Unit Assessment and Selection Project, 2008) When the same prescreen was used on the critical incident individuals, it was found that over 60% of the individuals would have been flagged as unacceptable. This would have saved the organization valuable resources and heartache.^ There were some subtle demographic differences between the two groups (i.e. those with critical incidents were almost twice as likely to be divorced compared with the positive performers). Upon comparison of Psychometric testing several items were noted to be different. The two groups were similar when their IQ levels were compared using the Multidimensional Aptitude Battery (MAB). When looking at the Minnesota Multiphasic Personality Inventory (MMPI), there appeared to be a difference on the MMPI Social Introversion; the Critical Incidence group scored somewhat higher. When analysis was done, the number of MMPI Critical Items between the two groups was similar as well. When scores on the NEO Personality Inventory (NEO) were compared, the critical incident individuals tended to score higher on Openness and on its subscales (Ideas, Actions, and Feelings). There was a positive correlation between Total Neuroticism T Score and number of MMPI critical items.^ Conclusions. This study shows that the current pre-screening process is working and would have saved the organization significant resources. ^ If one was to develop a profile of a candidate who potentially could suffer a critical incident and subsequently jeopardize the unit, mission and the safety of the public they would look like the following: either divorced or never married, score high on the MMPI in Social Introversion, score low on MMPI with an "excessive" amount of MMPI critical items; and finally scores high on the NEO Openness and subscales Ideas, Feelings, and Actions.^ Based on the results gleaned from the analysis in this study there seems to be several factors, within psychometric testing, that when taken together, will aid the evaluators in selecting only the highest quality operators in order to save resources and to help protect the public from unfortunate critical incidents which may adversely affect our health and safety.^

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The Centers for Disease Control estimates that foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year. The American public is becoming more health conscious and there has been an increase in the dietary intake of fresh fruits and vegetables. Affluence and demand for convenience has allowed consumers to opt for pre-processed packaged fresh fruits and vegetables. These pre-processed foods are considered Ready-to-Eat. They have many of the advantages of fresh produce without the inconvenience of processing at home. After seeing a decline in food-related illnesses between 1996 and 2004, due to an improvement in meat and poultry safety, tainted produce has tilted the numbers back. This has resulted in none of the Healthy People 2010 targets for food-related illness reduction being reached. Irradiation has been shown to be effective in eliminating many of the foodborne pathogens. The application of irradiation as a food safety treatment has been widely endorsed by many of the major associations involved with food safety and public health. Despite these endorsements there has been very little use of this technology to date for reducing the disease burden associated with the consumption of these products. A review of the available literature since the passage of the 1996 Food Quality Protection Act was conducted on the barriers to implementing irradiation as a food safety process for fresh fruits and vegetables. The impediments to adopting widespread utilization of irradiation food processing as a food safety measure involve a complex array of legislative, regulatory, industry, and consumer issues. The FDA’s approval process limits the expansion of the list of foods approved for the application of irradiation as a food safety process. There is also a lack of capacity within the industry to meet the needs of a geographically dispersed industry.^

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When a firm decides to implement ERP softwares, the resulting consequences can pervade all levels, includ- ing organization, process, control and available information. Therefore, the first decision to be made is which ERP solution must be adopted from a wide range of offers and vendors. To this end, this paper describes a methodology based on multi-criteria factors that directly affects the process to help managers make this de- cision. This methodology has been applied to a medium-size company in the Spanish metal transformation sector which is interested in updating its IT capabilities in order to obtain greater control of and better infor- mation about business, thus achieving a competitive advantage. The paper proposes a decision matrix which takes into account all critical factors in ERP selection.

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The use of cloud computing is extending to all kind of systems, including the ones that are part of Critical Infrastructures, and measuring the reliability is becoming more difficult. Computing is becoming the 5th utility, in part thanks to the use of cloud services. Cloud computing is used now by all types of systems and organizations, including critical infrastructure, creating hidden inter-dependencies on both public and private cloud models. This paper investigates the use of cloud computing by critical infrastructure systems, the reliability and continuity of services risks associated with their use by critical systems. Some examples are presented of their use by different critical industries, and even when the use of cloud computing by such systems is not widely extended, there is a future risk that this paper presents. The concepts of macro and micro dependability and the model we introduce are useful for inter-dependency definition and for analyzing the resilience of systems that depend on other systems, specifically in the cloud model.

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The need to refine models for best-estimate calculations, based on good-quality experimental data, has been expressed in many recent meetings in the field of nuclear applications. The modeling needs arising in this respect should not be limited to the currently available macroscopic methods but should be extended to next-generation analysis techniques that focus on more microscopic processes. One of the most valuable databases identified for the thermalhydraulics modeling was developed by the Nuclear Power Engineering Corporation (NUPEC), Japan. From 1987 to 1995, NUPEC performed steady-state and transient critical power and departure from nucleate boiling (DNB) test series based on the equivalent full-size mock-ups. Considering the reliability not only of the measured data, but also other relevant parameters such as the system pressure, inlet sub-cooling and rod surface temperature, these test series supplied the first substantial database for the development of truly mechanistic and consistent models for boiling transition and critical heat flux. Over the last few years the Pennsylvania State University (PSU) under the sponsorship of the U.S. Nuclear Regulatory Commission (NRC) has prepared, organized, conducted and summarized the OECD/NRC Full-size Fine-mesh Bundle Tests (BFBT) Benchmark. The international benchmark activities have been conducted in cooperation with the Nuclear Energy Agency/Organization for Economic Co-operation and Development (NEA/OECD) and Japan Nuclear Energy Safety (JNES) organization, Japan. Consequently, the JNES has made available the Boiling Water Reactor (BWR) NUPEC database for the purposes of the benchmark. Based on the success of the OECD/NRC BFBT benchmark the JNES has decided to release also the data based on the NUPEC Pressurized Water Reactor (PWR) subchannel and bundle tests for another follow-up international benchmark entitled OECD/NRC PWR Subchannel and Bundle Tests (PSBT) benchmark. This paper presents an application of the joint Penn State University/Technical University of Madrid (UPM) version of the well-known subchannel code COBRA-TF, namely CTF, to the critical power and departure from nucleate boiling (DNB) exercises of the OECD/NRC BFBT and PSBT benchmarks

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Railway bridges have specific requirements related to safety, which often are critical aspects of design. In this paper the main phenomena are reviewed, namely vertical dynamic effects for impact effect of moving loads and resonance in high-speed, service limit states which affect the safety of running traffic, and lateral dynamic effects.

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Tanto los robots autónomos móviles como los robots móviles remotamente operados se utilizan con éxito actualmente en un gran número de ámbitos, algunos de los cuales son tan dispares como la limpieza en el hogar, movimiento de productos en almacenes o la exploración espacial. Sin embargo, es difícil garantizar la ausencia de defectos en los programas que controlan dichos dispositivos, al igual que ocurre en otros sectores informáticos. Existen diferentes alternativas para medir la calidad de un sistema en el desempeño de las funciones para las que fue diseñado, siendo una de ellas la fiabilidad. En el caso de la mayoría de los sistemas físicos se detecta una degradación en la fiabilidad a medida que el sistema envejece. Esto es debido generalmente a efectos de desgaste. En el caso de los sistemas software esto no suele ocurrir, ya que los defectos que existen en ellos generalmente no han sido adquiridos con el paso del tiempo, sino que han sido insertados en el proceso de desarrollo de los mismos. Si dentro del proceso de generación de un sistema software se focaliza la atención en la etapa de codificación, podría plantearse un estudio que tratara de determinar la fiabilidad de distintos algoritmos, válidos para desempeñar el mismo cometido, según los posibles defectos que pudieran introducir los programadores. Este estudio básico podría tener diferentes aplicaciones, como por ejemplo elegir el algoritmo menos sensible a los defectos, para el desarrollo de un sistema crítico o establecer procedimientos de verificación y validación, más exigentes, si existe la necesidad de utilizar un algoritmo que tenga una alta sensibilidad a los defectos. En el presente trabajo de investigación se ha estudiado la influencia que tienen determinados tipos de defectos software en la fiabilidad de tres controladores de velocidad multivariable (PID, Fuzzy y LQR) al actuar en un robot móvil específico. La hipótesis planteada es que los controladores estudiados ofrecen distinta fiabilidad al verse afectados por similares patrones de defectos, lo cual ha sido confirmado por los resultados obtenidos. Desde el punto de vista de la planificación experimental, en primer lugar se realizaron los ensayos necesarios para determinar si los controladores de una misma familia (PID, Fuzzy o LQR) ofrecían una fiabilidad similar, bajo las mismas condiciones experimentales. Una vez confirmado este extremo, se eligió de forma aleatoria un representante de clase de cada familia de controladores, para efectuar una batería de pruebas más exhaustiva, con el objeto de obtener datos que permitieran comparar de una forma más completa la fiabilidad de los controladores bajo estudio. Ante la imposibilidad de realizar un elevado número de pruebas con un robot real, así como para evitar daños en un dispositivo que generalmente tiene un coste significativo, ha sido necesario construir un simulador multicomputador del robot. Dicho simulador ha sido utilizado tanto en las actividades de obtención de controladores bien ajustados, como en la realización de los diferentes ensayos necesarios para el experimento de fiabilidad. ABSTRACT Autonomous mobile robots and remotely operated robots are used successfully in very diverse scenarios, such as home cleaning, movement of goods in warehouses or space exploration. However, it is difficult to ensure the absence of defects in programs controlling these devices, as it happens in most computer sectors. There exist different quality measures of a system when performing the functions for which it was designed, among them, reliability. For most physical systems, a degradation occurs as the system ages. This is generally due to the wear effect. In software systems, this does not usually happen, and defects often come from system development and not from use. Let us assume that we focus on the coding stage in the software development pro¬cess. We could consider a study to find out the reliability of different and equally valid algorithms, taking into account any flaws that programmers may introduce. This basic study may have several applications, such as choosing the algorithm less sensitive to pro¬gramming defects for the development of a critical system. We could also establish more demanding procedures for verification and validation if we need an algorithm with high sensitivity to programming defects. In this thesis, we studied the influence of certain types of software defects in the reliability of three multivariable speed controllers (PID, Fuzzy and LQR) designed to work in a specific mobile robot. The hypothesis is that similar defect patterns affect differently the reliability of controllers, and it has been confirmed by the results. From the viewpoint of experimental planning, we followed these steps. First, we conducted the necessary test to determine if controllers of the same family (PID, Fuzzy or LQR) offered a similar reliability under the same experimental conditions. Then, a class representative was chosen at ramdom within each controller family to perform a more comprehensive test set, with the purpose of getting data to compare more extensively the reliability of the controllers under study. The impossibility of performing a large number of tests with a real robot and the need to prevent the damage of a device with a significant cost, lead us to construct a multicomputer robot simulator. This simulator has been used to obtain well adjusted controllers and to carry out the required reliability experiments.

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Abstract. The ASSERT project de?ned new software engineering methods and tools for the development of critical embedded real-time systems in the space domain. The ASSERT model-driven engineering process was one of the achievements of the project and is based on the concept of property- preserving model transformations. The key element of this process is that non-functional properties of the software system must be preserved during model transformations. Properties preservation is carried out through model transformations compliant with the Ravenscar Pro?le and provides a formal basis to the process. In this way, the so-called Ravenscar Computational Model is central to the whole ASSERT process. This paper describes the work done in the HWSWCO study, whose main objective has been to address the integration of the Hardware/Software co-design phase in the ASSERT process. In order to do that, non-functional properties of the software system must also be preserved during hardware synthesis. Keywords : Ada 2005, Ravenscar pro?le, Hardware/Software co-design, real- time systems, high-integrity systems, ORK

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During the last century many researches on the business, marketing and technology fields have developed the innovation research line and large amount of knowledge can be found in the literature. Currently, the importance of systematic and openness approaches to manage the available innovation sources is well established in many knowledge fields. Also in the software engineering sector, where the organizations need to absorb and to exploit as much innovative ideas as possible to get success in the current competitive environment. This Master Thesis presents an study related with the innovation sources in the software engineering eld. The main research goals of this work are the identication and the relevance assessment of the available innovation sources and the understanding of the trends on the innovation sources usage. Firstly, a general review of the literature have been conducted in order to define the research area and to identify research gaps. Secondly, the Systematic Literature Review (SLR) has been proposed as the research method in this work to report reliable conclusions collecting systematically quality evidences about the innovation sources in software engineering field. This contribution provides resources, built-on empirical studies included in the SLR, to support a systematic identication and an adequate exploitation of the innovation sources most suitable in the software engineering field. Several artefacts such as lists, taxonomies and relevance assessments of the innovation sources most suitable for software engineering have been built, and their usage trends in the last decades and their particularities on some countries and knowledge fields, especially on the software engineering, have been researched. This work can facilitate to researchers, managers and practitioners of innovative software organizations the systematization of critical activities on innovation processes like the identication and exploitation of the most suitable opportunities. Innovation researchers can use the results of this work to conduct research studies involving the innovation sources research area. Whereas, organization managers and software practitioners can use the provided outcomes in a systematic way to improve their innovation capability, increasing consequently the value creation in the processes that they run to provide products and services useful to their environment. In summary, this Master Thesis research the innovation sources in the software engineering field, providing useful resources to support an effective innovation sources management. Moreover, several aspects should be deeply study to increase the accuracy of the presented results and to obtain more resources built-on empirical knowledge. It can be supported by the INno- vation SOurces MAnagement (InSoMa) framework, which is introduced in this work in order to encourage openness and systematic approaches to identify and to exploit the innovation sources in the software engineering field.