Systems validation: application to statistical programs

BACKGROUND: In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which systems should undergo validation. Since statistical programs manage and manipulate raw data, their implementation should be critically reviewed to determine whether or not they should undergo validation. However, the concepts of validation are not often discussed in biostatistics curriculum. DISCUSSION: This paper summarizes a "Plan, Do, Say" approach to validation that can be incorporated into statistical training so that biostatisticians can understand and implement validation principles in their research. SUMMARY: Validation is a process that requires dedicated attention. The process of validation can be easily understood in the context of the scientific method

Experimental evaluation of two turning vane designs for fan drive corner of 0.1-scale model of NASA Lewis Research Center's proposed altitude wind tunnel

Two turning vane designs were experimentally evaluated for corner 2 of a 0.1 scale model of the NASA Lewis Research Center's proposed Altitude Wind Tunnel (AWT). Corner 2 contained a simulated shaft fairing for a fan drive system to be located downstream of the corner. The corner was tested with a bellmouth inlet followed by a 0.1 scale model of the crossleg diffuser designed to connect corners 1 and 2 of the AWT. Vane A was a controlled-diffusion airfoil shape; vane B was a circular-arc airfoil shape. The A vanes were tested in several arrangements which included the resetting of the vane angle by -5 degrees or the removal of the outer vane. The lowest total pressure loss for vane A configuration was obtained at the negative reset angle. The loss coefficient increased slightly with the Mach number, ranging from 0.165 to 0.175 with a loss coefficient of 0.170 at the inlet design Mach number of 0.24. Removal of the outer vane did not alter the loss. Vane B loss coefficients were essentially the same as those for the reset vane A configurations. The crossleg diffuser loss coefficient was 0.018 at the inlet design Mach number of 0.33

Covid-19 Impacts on Electronic Resource Usage at a Regional University

An analysis of electronic resource usage at a regional university in the southeast during the COVID-19 pandemic showed interesting results. While it was anticipated that movement to online instruction would increase usage of electronic resources, it was discovered that overall usage actually declined for those resources. Virtual reference transactions, however, increased during the pandemic. When meas-uring downloads of full-text of both journals and e-Books in the health sciences, humanities, social sci-ences, and physical sciences, it was discovered that the first three subject areas showed a double digit percentage decline in use, with only the physical sciences showing a decline of less than ten percent

The Value of the American Council of Learned Societies (ACLS) Humanities E-Book Collection: Is It Worth the Cost?

Auburn University at Montgomery (AUM) is a regional university located in Montgomery, Alabama. The enrollment consists of 3,990 FTE undergraduate and graduate students (Auburn University at Montgomery, 2017). The library at AUM holds nearly 600,000 volumes, excluding government documents, along with more than 100 journal databases, which support student and faculty research. Over the past five years, the materials budget has decreased more than 30%, requiring collection reductions. Initial analysis determined that in addition to other items, one of the recommended products for elimination was the American Council of Learned Societies (ACLS) Humanities E-Book project

Supersonic investigation of two dimensional hypersonic exhaust nozzles

An experimental investigation was conducted in the NASA Lewis 10 x 10 ft supersonic Wind Tunnel to determine the performance characteristics of 2D hypersonic exhaust nozzles/afterbodies at low supersonic conditions. Generally, this type of application requires a single expansion ramp nozzle (SERN) that is highly integrated with the airframe of the hypersonic vehicle. At design conditions (hypersonic speeds), the nozzle generally exhibits acceptable performance. At off-design conditions (transonic to mid-supersonic speeds), nozzle performance of a fixed geometry configuration is generally poor. Various 2-D nozzle configurations were tested at off-design conditions from Mach 2.0 to 3.5. Performance data is presented at nozzle pressure ratios from 1 to 35. Jet exhaust was simulated with high-pressure air. To study performance of different geometries, nozzle configurations were varied by interchanging the following model parts: internal upstream contour, expansion ramp, sidewalls, and cowl

Experimental evaluation of corner turning vanes

Two types of turning vane airfoils (a controlled-diffusion shape and a circular arc shape) have been evaluated in the high-speed and fan-drive corners of a 0.1-scale model of NASA Lewis Research Center's proposed Altitude Wind Tunnel. The high-speed corner was evaluated with and without a simulated engine exhaust removal scoop. The fan-drive corner was evaluated with and without the high-speed corner. Flow surveys of pressure and flow angle were taken for both the corners and the vanes to determine their respective losses. The two-dimensional vane losses were low; however, the overall corner losses were higher because three-dimensional flow was generated by the complex geometry resulting from the turning vanes intersecting the end wall. The three-dimensional effects were especially pronounced in the outer region of the circular corner

Using Choice to Measure the Availability and Use of E-Books

As e-books have come to hold a major impact on library collection building activities, the influence of reviews of titles and the on-going conversion of titles to a digital format have significant potential impacts for libraries. Reviewing tools such as Choice and the lag-time between publication notice of the print edition of a work and its corresponding e-version asks the questions, “How many of the print titles that are reviewed in Choice have a corresponding e-version ready for purchase?” and “How used are those e-versions in comparison with print?

Detailed flow surveys of turning vanes designed for a 0.1-scale model of NASA Lewis Research Center's proposed altitude wind tunnel

Detailed flow surveys downstream of the corner turning vanes and downstream of the fan inlet guide vanes have been obtained in a 0.1-scale model of the NASA Lewis Research Center's proposed Altitude Wind Tunnel. Two turning vane designs were evaluated in both corners 1 and 2 (the corners between the test section and the drive fan). Vane A was a controlled-diffusion airfoil and vane B was a circular-arc airfoil. At given flows the turning vane wakes were surveyed to determine the vane pressure losses. For both corners the vane A turning vane configuration gave lower losses than the vane B configuration in the regions where the flow regime should be representative of two-dimensional flow. For both vane sets the vane loss coefficient increased rapidly near the walls

Experimental Evaluation of Turning Vane Designs for High-speed and Coupled Fan-drive Corners of 0.1-scale Model of NASA Lewis Research Center's Proposed Altitude Wind Tunnel

Two turning vane designs were experimentally evaluated for the fan-drive corner (corner 2) coupled to an upstream diffuser and the high-speed corner (corner 1) of the 0.1 scale model of NASA Lewis Research Center's proposed Altitude Wind Tunnel. For corner 2 both a controlled-diffusion vane design (vane A4) and a circular-arc vane design (vane B) were studied. The corner 2 total pressure loss coefficient was about 0.12 with either vane design. This was about 25 percent less loss than when corner 2 was tested alone. Although the vane A4 design has the advantage of 20 percent fewer vanes than the vane B design, its vane shape is more complex. The effects of simulated inlet flow distortion on the overall losses for corner 1 or 2 were small