History File Research Articles

A Systems-Oriented Approach to Auditing the Design Controls Process: Part 2

Design Validation Auditors should confirm that the procedures in place controlling design validation are linked with design verification activities from a standpoint of assuring the success of this testing phase versus the essential requirements and acceptance criteria. Failing to assure that this objective evidence is in place can create a major void in the audit plan and the ultimate credibility of the design validation and ensuing data. This particular part of the total design controls process is linked strongly with production of product for use during this validation. Design validation shall ensure that devices conform to defined user needs and intended uses, and shall include testing of production units or their equivalent under actual or simulated use conditions. This rationale for design validation is not only auditable, but sets the stage for a linkage with process validation, ongoing confirmation of acceptable acceptance activities during manufacturing, and a defined basis for establishing the device master record. Design validation also includes software validation and risk analysis as part of the audit planning stage. The actual validation project is commonly protocol-driven and reports are summarily generated. For examples of auditable points during the design validation process, see Figure 1. Design Changes The details of the change-control system are left to the manufacturer to develop, document, and implement. As the design activity progresses toward the final stage, it is expected that the degree of change-control will increase. This is a fact that each audit checklist at every design phase needs to include to assure that changes made during the design control process are controlled and documented. The objective evidence will eventually be located in the design history file (DHF) and must have traceability not only to the change, but also to the ramifications of this change during design and, subsequently, in the quality management system. Because these following elements are under change-control, auditing the effects of the changes A Systems-Oriented Approach to Auditing the Design Controls Process: Part 2

The residential history file: studying nursing home residents' long-term care histories(*).

To construct a data tool, the Residential History File (RHF), that summarizes information from Medicare claims and nursing home (NH) Minimum Data Set (MDS) assessments to track people through health care locations, including non-Medicare-paid NH stays. Online Survey of Certification and Reporting (OSCAR) data for 202 free-standing NHs, Medicare Denominator, claims (parts A and B), and MDS assessments for 60,984 people who were present in one of these NHs in 2006. The algorithm creating the RHF is outlined and the RHF for the study data are used to describe place of death. The identification of residents in NHs is compared with the reports in OSCAR and part B claims. The RHF correctly identified 84.8 percent of part B claims with place-of-service in NH, and it identified 18.3 less residents on average than reported in the OSCAR on the day of the survey. The RHF indicated that 17.5 percent non-Medicare NH decedents were transferred to the hospital to die versus 45.6 percent skilled nursing facility decedents. The population-based design of the RHF makes it possible to conduct policy-relevant research to examine the variation in the rate and type of health care transitions across the United States.

Analysis of Internet Download Manager for collection of digital forensic artefacts

Internet Download Manager (IDM) provides accelerated download speed and flexibility in features. Its attractiveness lies behind video content processing and automatic handling of downloads. This paper analyzes IDM activities recorded across multiple files that includes Windows Registry, history and log files from artefacts collection view point. The tools and techniques used for extracting evidence are also elaborated. In case of download managers, the foremost concerns are installation location, download path, downloaded file, URL address, login credentials for password protected websites, date and time the activity was performed. This enables digital forensic investigators to envisage and deduce suspicious activities.

A Systems-Oriented Approach to Auditing the Design Controls Process

Design Validation Auditors should confirm that the procedures in place controlling design validation are linked with design verification activities from a standpoint of assuring the success of this testing phase versus the essential requirements and acceptance criteria. Failing to assure that this objective evidence is in place can create a major void in the audit plan and the ultimate credibility of the design validation and ensuing data. This particular part of the total design controls process is linked strongly with production of product for use during this validation. Design validation shall ensure that devices conform to defined user needs and intended uses, and shall include testing of production units or their equivalent under actual or simulated use conditions. This rationale for design validation is not only auditable, but sets the stage for a linkage with process validation, ongoing confirmation of acceptable acceptance activities during manufacturing, and a defined basis for establishing the device master record. Design validation also includes software validation and risk analysis as part of the audit planning stage. The actual validation project is commonly protocol-driven and reports are summarily generated. For examples of auditable points during the design validation process, see Figure 1. Design Changes The details of the change-control system are left to the manufacturer to develop, document, and implement. As the design activity progresses toward the final stage, it is expected that the degree of change-control will increase. This is a fact that each audit checklist at every design phase needs to include to assure that changes made during the design control process are controlled and documented. The objective evidence will eventually be located in the design history file (DHF) and must have traceability not only to the change, but also to the ramifications of this change during design and, subsequently, in the quality management system. Because these following elements are under change-control, auditing the effects of the changes A Systems-Oriented Approach to Auditing the Design Controls Process: Part 2

‘Differences … in Dealing with The Australian Public’: Australia as A Foreign Market in the 1920s

‘Differences … in Dealing with The Australian Public’: Australia as A Foreign Market in the 1920s

Speech Recordings at the British Library

A single historical sound file posted on the web by the British Library may reach more listeners in a day than it did in the whole of the pre-internet age of telephone enquiries and listening appointments on the premises. Yet most of the Library’s vast sound archive remains available for consultation only through outmoded facilities. Why is this, and how does a national sound archive respond to rapidly changing and increasingly demanding user expectations?

The inference problem: Maintaining maximal availability in the presence of database updates

In this paper, we present the Dynamic Disclosure Monitor (D 2Mon) architecture to prevent illegal inferences via database constraints. D 2Mon extends the functionality of Disclosure Monitor (DiMon) to address database updates while preserving the soundness and completeness properties of the inference algorithms. We study updates from the perspective of increasing data availability. That is, updates on tuples that were previously released may affect the correctness of the user inferences over these tuples. We develop a mechanism, called Update Consolidator (UpCon), that propagates updates to a history file to ensure that no query is rejected based on inferences derived from outdated data. The history file is used by the Disclosure Inference Engine (DiIE) to compute inferences. We show that UpCon and DiIE working together guarantee confidentiality (completeness property of the data-dependent disclosure inference algorithm) and maximal availability (soundness property of the data-dependent disclosure inference algorithm) even in the presence of updates. We also present our implementation of D 2Mon and our empirical results.

Spontaneous rupture of subserous uterine veins during late pregnancy after in vitro fertilization

To report the clinical presentation and treatment of spontaneous rupture of uterine surface veins during late pregnancy after in vitro fertilization (IVF). Case report. Medical Unit of Third Hospital of Peking University, Beijing, China. A total of 573 pregnancies resulting from IVF in our hospital were reviewed for examples of spontaneous rupture of uterine veins. Data were obtained from medical charts, delivery summaries, and surgical reports in the historical files. Explorative laparotomy was performed. Three women were found experiencing significant intra-abdominal bleeding in the third trimester of pregnancy due to a lesion resulting from endometriosis and chronic pelvic inflammatory disease. The intra-abdominal bleeding occurred between 29 and 35 weeks of gestation. A major prenatal symptom was severe abdominal pain in all of the cases. The pain was not relieved by the application of tocolytics or mild analgesics. Explorative laparotomy, performed in all three cases, revealed the presence of massive intra-abdominal bleeding stemming from subserous uterine veins. Fetal death occurred in one case. Immediate institution of effective resuscitative measures and early surgical intervention were essential to both fetal and maternal survival. Patients undergoing IVF treatment may be at increasing risk for intra-abdominal bleeding in the third trimester of pregnancy.

Design and development of correlation techniques to maintain a space surveillance system catalogue

A growing interest exists in a future, autonomous European Space Surveillance System (ESSS). Currently, most of the knowledge about Earth-orbiting space objects is based on information provided by the USASPACECOM. This paper presents the required initial orbit determination (IOD) and correlation techniques to process optical measurements. Former studies were focused on the handling of radar measurements, which are summarised with the aim of describing a global procedure for processing hybrid measurement types (combination of radar and optic data for catalogue maintenance). The introduction of manoeuvres are presented due to their importance in the space object catalogue maintenance. The detection of uncatalogued objects and the successful correlation of already catalogued objects involve two different tasks for telescopes: survey and tasking. Assumptions for both strategies are developed on the basis of the previous work developed at the University of Berne (see [T. Flohrer, T. Schildknecht, R. Musci, E. Stöveken, Performance estimation for GEO space surveillance, Advances in Space Research 35 (2005). [1]; T. Flohrer, T. Schildknecht, R. Musci, Proposed strategies for optical observations in a future European Space Surveillance Network, presented in the 36th COSPAR Scientific Assembly (2006). [2]; R. Musci, T. Schildknecht, M. Ploner, Orbit improvement for GEO objects using follow-up observations, Advances in Space Research 34 (2004). [3]; R. Musci, T. Schildknecht, M. Ploner, G. Beutler, Orbit improvement for GTO objects using follow-up observations, Advances in Space Research 35 (2005). [4]; R. Musci, T. Schildknecht, T. Flohrer, G. Beutler, Concept for a catalogue of space debris in GEO, Proceedings of the Fourth European Conference on Space Debris, (ESA SP-587, 2005). [5]]). When a new object appears in the field of view, initial orbit determination must be performed. When only one telescope per site is available, the initial measurements are separated by only a few seconds. Therefore, the initial orbit determination is quite inaccurate due to bad mathematical conditioning of the problem. In order to improve the accuracy of the initial orbit determination, several follow-up observations of the object are required. This implies that the telescope needs to track the detected objects over a long period, and therefore the time available for surveying is reduced. By processing the additional follow-up measurements, separated now by a few hours, the initial orbit determination gives more accurate results and the object can be recovered after an orbital revolution. When several telescopes per site are available, the optical strategies may be modified. The survey tasks can be distributed between the available telescopes. In this way the number of images corresponding to each object increases and to track the detected object over long periods is not always needed. Numerical results will be shown in order to evaluate the accuracy and features of the different telescope strategies. A key point for performing efficiently the cataloguing process is the calculation of the estimated state vector covariance matrix. The covariance matrix analysis allows an adaptive tasking-survey telescope scheduling. Moreover, the implementation of a proper batch orbit determination process by means of a square root information filter (SRIF) requires a realistic initial covariance matrix. Hybrid measurements are available from objects that can be observed through both radar and optical sensors (e.g. GTO objects). The batch orbit determination and correlation process of hybrid measurements is also based on SRIF using an extended measurement model. Both the initial orbit determination methods using radar and optical measurements have to be sufficiently accurate to initialise SRIF correctly. In order to avoid filter divergence, the estimated covariance must be correctly updated after processing both kinds of measurements. The implemented algorithms are explained and their performance is shown through realistic simulations. Techniques to detect and characterise object manoeuvres during the cataloguing process have been developed and implemented. Four main groups of manoeuvre objects have been established by means of their observed permitted orbital ranges (GEO, LEO, MEO–GPS, Molniya). The study is based on the historical TLEs files. When an object with an uncatalogued orbit appears, a comparison between the new orbit and the orbits contained in the permitted ranges of one of the manoeuvre groups is performed. If the required Δ a and/or Δ i to convert the lost orbit into the detected orbit seems to be feasible, a manoeuvre will be identified and the orbit will be updated in the catalogue. Otherwise, it will be decided that a new object was found. For this purpose, a procedure to estimate the manoeuvres and reset orbits have been developed.

Effect of Data Processing on Data Quality

Problem statement: Great attention had been paid on spatial data quality by the scientific community. This was due to the negative impact that a poor spatial data quality had on the competitiveness of an organization. On other hand, we can never obtain good quality data from a poor quality data. In this study, we demonstrate the effects of the different processing and preprocessing on the quality of spatial data. As we know each type of processing introduces errors and deformations at the original spatial data. Approach: Field applications and real samples were presented to prove the effect of data processing on data quality. We used spectrally and spatially processed satellite images which present the following areas: (i) Greater Amman area, (ii) Walla and Habisse basins. Different types of processing using different scales and resolutions were applied to field applications to evaluate the effect of scale, resolution and electronic transfer from vector to raster. Results: The vector layers extracted from these spatial data at different scales and resolutions were compared to each other. The comparison showed a great deformation in shape and value. This research demonstrates the influence of the scale, the resolution and transformation from vector to raster of spatial data base on the accuracy. Conclusion: We concluded that scale, resolution and electronic transfer have great effects on data quality. This effect should be considered in building any data base and all data base must have history file for evaluating its accuracy quality.

Tracking transaction footprints for non-intrusive end-to-end monitoring

Existing transaction monitoring solutions are either platform-specific or rely on instrumentation techniques, which limit their applicability. Consequently, transaction monitoring in enterprise environments often involves the manual collation of information spread across a variety of infrastructure elements and applications, and is a time-consuming and labor-intensive task. To address this problem, we have developed an online, non-intrusive and platform-agnostic solution for transaction monitoring. The solution includes a transaction model discovery component that leverages historical system log files, containing transaction footprints and generates a model of the transaction in terms of valid sequence of steps that a transaction instance may execute and the expected footprint patterns at each step. The online monitoring system, in turn, takes in only (a) online system log files and (b) the transaction model, as inputs and generates a dynamic execution profile of ongoing transaction instances that allows their status to be tracked at individual and aggregate levels, even when transaction footprints do not necessarily carry correlating identifiers as those injected through instrumentation. In this paper, we describe the transaction model discovery and monitoring system including the architecture and algorithms, followed by results from an empirical study, ongoing work on run-time model validation and directions for future research.

Using the HFS+ journal for deleted file recovery

This paper describes research and analysis that were performed to identify a robust and accurate method for identifying and extracting the residual contents of deleted files stored within an HFS+ file system. A survey performed during 2005 of existing tools and techniques for HFS+ deleted file recovery reinforced the need for newer, more accurate techniques. Our research and analysis were based on the premise that a transactional history of file I/O operations is maintained in a Journal on HFS+ file systems, and that this history could be used to reconstruct recent deletions of active files from the file system. Such an approach offered a distinct advantage over other current techniques, including recovery of free/unallocated blocks and “file carving” techniques. If the journal entries contained or referenced file attributes such as the extents that specify which file system blocks were occupied by each file, then a much more accurate identification and recovery of deleted file data would be possible.

Establishment of the Royal Norwegian Navy Personnel Cohorts for Cancer Incidence and Mortality Studies

Media focus on health problems among personnel in the Royal Norwegian Navy spurred a broad scale investigation, including cancer incidence and mortality studies. The studies were planned as historical prospective cohort studies. Cohorts of military and civilian personnel serving in the Navy during 1950 to 2005 were established by manually entering paper-based service history files into the data system at the Headquarters Defence Command Norway. The files were collected from Headquarters Defence Command Norway, the naval bases, and the National Archives of Norway. The military cohort consists of 29,056 officers and enlisted personnel (2.5% women) with an average of 6 years of service in the Navy. Year of birth spans 1883 to 1985; the median is 1954. The cohort of 8,378 civilians (39% women) has an average of 11 years in the Navy; the year of birth spans 1884 to 1988 with a median of 1942. Both cohorts are regarded as virtually complete.

Coarse Particulate Matter Air Pollution and Hospital Admissions for Cardiovascular and Respiratory Diseases Among Medicare Patients

Health risks of fine particulate matter of 2.5 microm or less in aerodynamic diameter (PM2.5) have been studied extensively over the last decade. Evidence concerning the health risks of the coarse fraction of greater than 2.5 microm and 10 microm or less in aerodynamic diameter (PM10-2.5) is limited. To estimate risk of hospital admissions for cardiovascular and respiratory diseases associated with PM10-2.5 exposure, controlling for PM2.5. Using a database assembled for 108 US counties with daily cardiovascular and respiratory disease admission rates, temperature and dew-point temperature, and PM10-2.5 and PM2.5 concentrations were calculated with monitoring data as an exposure surrogate from January 1, 1999, through December 31, 2005. Admission rates were constructed from the Medicare National Claims History Files, for a study population of approximately 12 million Medicare enrollees living on average 9 miles (14.4 km) from collocated pairs of PM10 and PM2.5 monitors. Daily counts of county-wide emergency hospital admissions for primary diagnoses of cardiovascular or respiratory disease. There were 3.7 million cardiovascular disease and 1.4 million respiratory disease admissions. A 10-microg/m3 increase in PM10-2.5 was associated with a 0.36% (95% posterior interval [PI], 0.05% to 0.68%) increase in cardiovascular disease admissions on the same day. However, when adjusted for PM2.5, the association was no longer statistically significant (0.25%; 95% PI, -0.11% to 0.60%). A 10-microg/m3 increase in PM10-2.5 was associated with a nonstatistically significant unadjusted 0.33% (95% PI, -0.21% to 0.86%) increase in respiratory disease admissions and with a 0.26% (95% PI, -0.32% to 0.84%) increase in respiratory disease admissions when adjusted for PM2.5. The unadjusted associations of PM2.5 with cardiovascular and respiratory disease admissions were 0.71% (95% PI, 0.45%-0.96%) for same-day exposure and 0.44% (95% PI, 0.06% to 0.82%) for exposure 2 days before hospital admission. After adjustment for PM2.5, there were no statistically significant associations between coarse particulates and hospital admissions for cardiovascular and respiratory diseases.

Cancer mortality in IBM Endicott plant workers, 1969–2001: an update on a NY production plant

BackgroundIn response to concerns expressed by workers at a public meeting, we analyzed the mortality experience of workers who were employed at the IBM plant in Endicott, New York and died between 1969–2001. An epidemiologic feasibility assessment indicated potential worker exposure to several known and suspected carcinogens at this plant.MethodsWe used the mortality and work history files produced under a court order and used in a previous mortality analysis. Using publicly available data for the state of New York as a standard of comparison, we conducted proportional cancer mortality (PCMR) analysis.ResultsThe results showed significantly increased mortality due to melanoma (PCMR = 367; 95% CI: 119, 856) and lymphoma (PCMR = 220; 95% CI: 101, 419) in males and modestly increased mortality due to kidney cancer (PCMR = 165; 95% CI: 45, 421) and brain cancer (PCMR = 190; 95% CI: 52, 485) in males and breast cancer (PCMR = 126; 95% CI: 34, 321) in females.ConclusionThese results are similar to results from a previous IBM mortality study and support the need for a full cohort mortality analysis such as the one being planned by the National Institute for Occupational Safety and Health.

Usuarios de información pública de la ciudad de Jaén (1976-1996)

Taking as source of intelligence more than 13,000 consultations carried out by Administration public to his archives and requests made by investigators, present article shows yield of file, since it is source of intelligence as much for the organism that generates it, like for the citizenship in general, investigators in individual and the coming generations like source of intelligence of official history. In addition to the definition of the profile of users of the Provincial Historical File of Jaen, Municipal File of Jaen and the File of Provincial Delegation, contributes the definition of these investigations, the objectives that are tried to obtain, the used methodology, the location of these quantitative techniques in the technical subsystem, like powerful tool for its evaluation, conclusions destined to the promotion of these studies, doing emphasis in the importance of the Documentation like science applied to other disciplines, and an extensive bibliography for the theoretical elaboration of investigations of these characteristics.

Testing a priority-based queue model with Linux command histories

We study human dynamics by analyzing Linux history files. The goodness-of-fit test shows that most of the collected datasets belong to the universality class suggested in the literature by a variable-length queuing process based on priority. In order to check the validity of this model, we design two tests based on mutual information between time intervals and a mathematical relationship known as the arcsine law. Since the previously suggested queuing process fails to pass these tests, the result suggests that the modelling of human dynamics should properly consider the statistical dependency in the temporal dimension.

Collective prenatal consultation: a new proposal for comprehensive health care

This article describes the Collective Prenatal Consultation as a new healthcare methodology, which is performed according to government standards, but collectively. Relaxation and sensitization techniques are used, as well as group dynamics, including a collective exam of the pregnant women. The Collective Consultation is carried out in a welcoming environment, which provides clarification and socialization of experiences and information, centered on those women. The healthcare professional records every obstetric parameter and behavior in the patient's prenatal card and history file. Priority is given to the principle of integrality and citizenship, with the aim to break the biomedical care paradigm, thus favoring humanized and comprehensive care to the women.

The representation of Caesalpinia echinata (Brazilwood) in Sixteenth-and-Seventeenth-Century Maps

Brazilwood was the first product found in Terra de Santa Cruz, and the first explored by Portuguese colonization of Brazil. This study aims at the Occidental Cartography and the historical files represented by Portugal's interest on mapping the marketed product found in Brazil. There presentation of Brazilwood in maps was possible due to scientific advancements, new land discoveries, and technological improvement during the 15th century, which all have taken cartography to a whole new period, stressing Portuguese hegemony in Asia and in the New World. The goal of this research was to identify and analyze maps from 16th and 17th centuries that represented the geographical distribution of Brazilwood, and its trade. Brazilwood was represented in many maps by illumination and detailed by different cartographers. The maps and other evidence for this research were found in historical files held in both Brazil and Portugal.

Refinement of the Spitzer Space Telescope Pointing History Based on Image Registration Corrections from Multiple Data Channels

ABSTRACTPosition reconstruction for images acquired by the Infrared Array Camera (IRAC), one of the science instruments onboard the Spitzer Space Telescope, is a multistep procedure that is part of the routine processing done at the Spitzer Science Center (SSC). The IRAC instrument simultaneously images two different sky footprints, each with two independent infrared passbands (channels). The accuracy of the initial Spitzer pointing reconstruction is typically slightly better than 1″. The well‐known technique of position matching imaged point sources to even more accurate star catalogs to refine the pointing further is implemented for SSC processing of IRAC data as well. Beyond that, the optimal processing of redundant pointing information from multiple instrument channels to yield an even better solution is also performed at the SSC. Our multichannel data processing approach is particularly beneficial when the star‐catalog matches are sparse in one channel but copious in others. A thorough review of the algorithm as implemented for the Spitzer mission reveals that the mathematical formalism can be fairly easily generalized for application to other astronomy missions. The computation of pointing uncertainties, the interpolation of pointing corrections and their uncertainties between measurements, and the estimation of random‐walk deviations from linearity are special areas of importance when implementing the method. After performing the operations described in this paper on the initial Spitzer pointing, the uncertainty in the observatory pointing history file is reduced 10–15 fold.