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Killexams : GuidanceSoftware resources - BingNews Search results Killexams : GuidanceSoftware resources - BingNews Killexams : Artificial Intelligence And Its Impact On Contingent Workforce Management

One of the most important undertakings an enterprise has to deal with is finding and hiring an amazing candidate. But the fierce competition for talent, lackluster recruiting and sourcing processes and uncoordinated evaluation criteria make it an arduous task.

Astoundingly, 74% of employers claim they’ve hired the wrong person for a position. These hires come at a cost, with organizations losing an average of nearly $15,000 on every bad hire.

It's enticing to tap into artificial intelligence to help with hiring, managing and optimizing contingent workers. Machine learning, predictive analytics and augmented reality offer tantalizing possibilities to increase efficiency, reduce operational costs, grow revenue and Excellerate talent quality.

Business leaders have taken notice, with nearly three in four considering AI a “business advantage” that will be fundamental to their future operations. Adoption remains in the early stages, with only 20% of executives reporting using one or more AI technologies at scale or in a core part of their business.

What Is Artificial Intelligence?

AI has been around for decades, but we have seen major developments over the past 10 years in this space. Innovation has led to the development of intelligent machines that can carry out human tasks. Harnessed correctly, AI will enable businesses to make sense of massive amounts of structured and unstructured data and make faster, smarter decisions that drive cost savings and Excellerate the end user experience. Key subsets of AI include:

• Virtual assistants: Technology that uses natural language processing of text and/or voice to communicate with users and help them with tasks.

• Augmented reality: The creation of an enhanced, interactive version of reality that uses technology to overlay digital information onto an existing environment.

• Machine learning: Technology that uses large amounts of data and algorithms in order to analyze and comprehend the information and then supply it the ability to learn.

Cognitive computing: Combines machine learning, data mining, pattern recognition and natural language processing, speech, vision and human-computer interaction to imitate human brain functions and to help enhance decision making.

• Predictive analytics: Utilizes data, statistical algorithms and machine learning technology to predict future outcomes.

Although specific functionality may vary slightly based on industry and related use cases, the promise of AI in the contingent labor space is similar across the board. First, it will enable organizations to make better hiring decisions. Secondly, it will allow businesses to more efficiently manage their contingent workforces. And finally, it will enhance the user experience.

 Innovation, Artificial Intelligence And Contingent Workforce Management

AI is a broad subject with wide-reaching implications for organizations and their business processes. The following four areas stand out as having intriguing application specifically to contingent workforce management:

Adaptive Job Assessments

One of a vendor management system’s most critical functions is helping hiring managers find the best candidates to fill job openings. AI can help take this matching to the next level, using machine learning coupled with adaptive online assessments and games to predict job performance for specific roles. Employed in this fashion, AI could potentially enable hiring managers to make wiser decisions that would decrease time to fill, maximize talent and reduce cost.

Social And Behavioral Data Mining

Today, there’s a wealth of social and behavioral data available over the web, social media networks and more. However, it’s been difficult for organizations to harness this unstructured data. Advances in cognitive computing and deeper machine learning are starting to enable businesses to put this data into action. One of AI’s biggest strengths lies in its ability to sift through millions of unstructured data points and make sense of them quickly.

Enterprises could leverage this functionality to mine social and behavioral data and use it to better match job candidates to open positions.

Embedded Intelligence

The best VMS platforms offer guidance software aimed at making users’ workflows easier, simpler and more efficient. The next frontier in this area is AI-powered embedded intelligence -- a form of virtual assistant that would help users with tasks throughout the contingent workforce management life cycle.

Business processes, managerial preferences and company policies could be built into the system to help the virtual assistant “bubble up” more relevant suggestions. Advances in this type of functionality will drive user engagement and deliver a better customer experience.

Augmented Reality

What if you could take an inanimate object and make it come to life? With augmented reality, this once-hypothetical scenario can become actualized. With a simple wave of the phone, an employee can watch related videos and even have a two-way conversation with a company handbook. With contingent managers and workers alike increasingly on the go, the ability to leverage augmented reality to bring a company’s physical locations or workspaces to life has exciting potential to Excellerate efficiency.


The increased integration of AI into existing technologies is poised to unlock a wealth of opportunities for companies. By analyzing data sets and performing automated work behind the scenes, AI promises to enable faster decision-making and free up valuable resources for stakeholders. AI has the potential to provide a wealth of insights that both confirm and dispute previously assumed hypotheses. Employed strategically, these ideas could reveal new ways to increase hiring success and deepen understanding of a company’s workforce. Combined with human expertise, this augmented intelligence will help businesses drive cost savings, increase talent quality and Excellerate the effectiveness of their contingent workforce programs.

Wed, 18 Apr 2018 04:22:00 -0500 Ted Sergott en text/html
Killexams : Anthony Di Bello

As the Director of the Security Practice for Guidance Software, Anthony Di Bello is responsible for providing in-depth insight into the advanced threat landscape. Since joining the company in 2005, he has been instrumental in defining the company's suite of security products, introducing new products and successfully driving market adoption with Fortune 500 companies and federal government agencies. Prior to joining Guidance Software, Di Bello spent seven years with Towers Perrin, a global professional services firm specializing in risk and financial management. He is a frequent speaker and is quoted regularly in key industry publications.

Fri, 03 Oct 2014 03:05:00 -0500 en text/html
Killexams : Patrick Dennis Takes The Reins At ExtraHop

ExtraHop had an exceptional year in 2021, and Arif Kareem, the outgoing former CEO, decided to go out on a high note and retire. Today, ExtraHop announced that Patrick Dennis will assume the role of CEO.

Dennis inherits a company with solid momentum. ExtraHop, a cloud-native network detection and response (NDR) company, grew annual recurring revenue (ARR) by 47% to $140 million in 2021—driven by 54% year-over-year growth in new customer acquisition. The company also expanded its global footprint across Japan, Germany, Australia, and the Middle East.

Introducing Patrick Dennis

A press release from ExtraHop describes the new CEO. “Dennis has nearly 25 years of experience leading high-growth public and private companies in the security and information technology markets including CEO roles at Guidance Software and Alvaria, and leadership positions at EMC and Oracle. His vision and leadership have helped companies like ExtraHop achieve multi-year growth through strategic product investments, international expansion, and a customer-centric approach.”

The ‘COVID Effect’

I had an opportunity to speak with Dennis about where ExtraHop is as he assumes the CEO role, and what the future holds for the company.

One of the driving forces for IT and cybersecurity over the past couple years is the COVID-19 pandemic. More precisely, it’s the digital transformation organizations were forced to accelerate or adopt overnight, and the dramatic shift brought on by suddenly having to manage data and assets across public and personal networks as individuals work remotely from home. It has made the attack surface significantly more complex and provided new opportunities for threat actors.

We spoke about what that means for visibility—for the ability of IT and security managers to know exactly what devices and applications are connected to their network, and who or what are accessing and transferring data. Organizations struggled with visibility and cybersecurity before the pandemic, but now the whole world is the network and every device is the “perimeter,” so it has become exponentially more challenging.

It is an issue that is exacerbated by the fact that—in many cases—the endpoints are not managed by the company. Employees are using home PCs and personal mobile devices to connect to business networks and data. It simultaneously increases the risk while reducing the ability for the security team to address it.

Dennis explained, “You start to apply artificial intelligence and machine learning practices across the network in a way that lets you get observability that you didn't have before and get some visibility, you know, in real time, or near real time, even as things are headed toward places you may not have control of.”

He added, “I actually think this is the moment where—and it’s not taking anything away from endpoint because endpoint security is important, too—but you need something that’s an “and” because you weren't going to solve it all at the endpoint.”

That is where a company like ExtraHop comes in. Dennis talked about how the nature of the traffic traversing the network is provides an amazing opportunity to isolate attacks and threats, and that this is the reason that right now is the time for NDR.

The Road Ahead

Many times when a new CEO comes in, it’s to fix things the former CEO broke and try to save the company, or to recover after some sort of executive scandal. That is not the case with ExtraHop. This transition is happening because Arif is ready to move on and seek new experiences, and he is leaving Dennis with a rocket ship on a solid trajectory.

With that in mind, I asked him what the next few months, or the rest of 2022 might look like, and what his priorities for the company are. He responded “We’re going to focus on the mission of cybersecurity.”

What does that mean? Dennis elaborated, “We want to make sure the organization stays super customer-centric. We want to make sure we get really precise on what problems we're solving for these customers. And, we want to make sure we go tell that story to as many customers as we can.”

Dennis summed it up in a blog post. “This is an important time in the world, and an important time in cybersecurity. We exist in a state of continuous compromise, where advanced threats are pervasive and attack techniques have outpaced the tools and resources we have to reliably defend against them. This isn’t a reason to supply up. This is an opportunity for all of us––technologists, defenders, business leaders––to make a meaningful impact. I joined ExtraHop because I believe this company can disproportionally contribute to that impact.”

Tue, 15 Feb 2022 00:56:00 -0600 Tony Bradley en text/html
Killexams : Software tools and code

During their research, most fellows wrote code in languages such as Python, Matlab and R. Where the codes were likely to be useful to others, and in a format capable of being used, they have been shared through various different sites.

The table below provides a list of these tools, the fellows involved and a link to the tool. Click on the tool name for further details, including links to associated reports and papers.

EmiStatR and stUPscales (formerly AggProp)

EmiStatR: This R-package provides a fast and parallelised calculator to estimate wastewater emissions from combined sewers.  It also supports the planning and design of urban drainage systems, without the requirement of extensive simulation tools.

EmiStatR is available on CRAN and also further described in this MDPI Water paper.

stUPscales (Spatio-temporal Uncertainty Propagation across scales) - formerly known as AggProp: Provides several R methods and functions for temporal aggregation of environmental variables as precipitation and pollutants of Urban Drainage Models (UDMs). Also, it provides methods and functions for uncertainty propagation for lumped UDMs via Monte Carlo simulation.

stUPscales is available on Github and should soon be available on CRAN.  It is further described in this MDPI Water paper.

These tools are described in deliverable report 2.3, although have continued to be developed so also so the journal papers mentioned for each tool.

spup: Spatial Uncertainty Propagation Analysis

The R package ‘spup’ implements uncertainty propagation analysis in spatial environmental modelling following the methodology described in Heuvelink et al. (2007) and Brown and Heuvelink (2007). The package provides functions for examining uncertainty propagation starting from input data and model parameters, via the environmental model onto model outputs. The functions include uncertainty model specification, stochastic simulation and propagation of uncertainty using Monte Carlo (MC) techniques. Uncertain variables are described by probability distributions. Both numerical and categorical data types are handled. Spatial auto-correlation within an attribute and cross-correlation between attributes is accommodated for. The MC realizations may be used as input to the environmental models called from R, or externally.

The package is available on CRAN.


The main author of this tool is Tobias Houska.  Within the QUICS project, Carla has used and added to this tool.

A Statistical Parameter Optimization Tool, SPOTPY is a Python tool that enables the use of Computational optimization techniques for calibration, uncertainty and sensitivity analysis techniques of almost every (environmental) model. The package is puplished in the open source journal PLoS One: Houska, T, Kraft, P, Chamorro-Chavez, A and Breuer, L; SPOTting Model Parameters Using a Ready-Made Python Package; PLoS ONE; 2015 The simplicity and flexibility enables the use and test of different algorithms without the need of complex codes, doi: 10.1371/journal.pone.0145180.

SPOTPY is available on PyPI.  There is also further information in Deliverable 1.4 and a case study utilising SPOTPY is described in Deliverable 4.1.

Various tools related to rainfall ensembles, mergingin radar and rain gauge data and kriging

Ensemble Generator.R: Geostatistical Radar Ensemble Generator (GREG)
KEDUD.R: Kriging with External Drift for Uncertain Data (KEDUD)
KED_with_optimal_BoxCox.R: KED radar-gauge merging with optimised Box-Cox lambda
Negentropy.R: KED radar-gauge merging with optimised Box-Cox lambda
OKUD.R: Ordinary Kriging for Uncertain Data (OKUD)
QQplots_function.R: KED radar-gauge merging with optimised Box-Cox lambda
RG_validation_function.R: KED radar-gauge merging with optimised Box-Cox lambda
Residual_gaussianity_function.R: KED radar-gauge merging with optimised Box-Cox lambda

These tools are available on Github and are also closely linked to the work in Deliverable 3.2.


Python scripts for water quality simulators WEST (MIKE DHI). Sensitivity analysis, inference and automated runs.

The scripts are available on Github.

Data-driven Gaussian Process Emulator (GPE) technique to develop a surrogate model for computationally expensive and detailed urban drainage simulators

The novelty of this work is the consideration of (short) time series for the simulation inputs and outputs. Such simulation setup is interesting in applications such as Model Predictive Control (MPC) in which numerous, fast and frequent simulation results are required. Here, an emulator is developed to predict a storage tank’s volume in a small case study in Luxembourg. Three main inputs are considered as the GPE’s parameters: initial volume in the tank, the level in which the outlet pump of the tank must start to work, and the time series of expected rainfall in the upcoming 2 hours. The output of interest is the total volume of the storage tank for the next 24 hours.

The code (in R) and the simulation and validation data-sets will be available after publication of this research.


Temporal Uncertainty Propogation Asross Scales, stUPscales, provides several R functions for temporal aggregation of enviornmental variables used in Urban Drainage Models, such as precipitation and pollutants.  It also provides methods and functions for ucertainty propgation via Monte Carlo simulation; and provides specific analysis functions for urban drainage system simulation to evaluate water quantity and quality in combined sewer overflows (CSOs).

The package is available on Github.

Computational library in the open source language R of efficient algorithms for adaptive MCMC sampling and/or posterior emulation

One challenge in uncertainty estimation of environmental models is the high number of parameters, as well as model structure errors. The first make traditional optimisation routines difficult due to co-linearities of model parameters. The second often require additional error terms which capture these structural deficits with stochastic processes.

Inference with the latter requires Bayesian inference methods for model calibration, which typically rely on sampling from the posterior. Obtaining a reliable estimate of the posterior usually requires many thousand iterative model runs and there is the danger that sampling a very complex posterior distribution is inadequate due to too few iterations.

Efficient samplers have been proposed to relax this problem by increasing the acceptance rate due to sophisticated proposal algorithms, such as adaptive sampling or parallelizing the inference with ensembles.

Three open source computational libraries of efficient algorithms for adaptive (1) and ensemble-based MCMC (Monte Carlo Markov Chain) sampling (2). In addition, we explore and compare the effectiveness of each sampler in standardized inference problems are presented. For full details, see Deliverable 1.2.

The MCMC sampler is available on github for both R and Julia.  The Generic adaptive MCMC  sampler proposed by Vihola (2011) is available on github.

An improved sediment wash-off model for urban impervious surfaces

Deliverable 2.4 describes the development of an improved sediment wash-off model for urban impervious surfaces.  The revised model has been implemented in R and is available as a web app.

Sampling design optimisation of a non-stationary variance model

These codes are closely linked to Deliverable 3.1 and the journal papers "Sampling design optimisation for rainfall prediction using a non-stationary geostatistical model" which is Open Access published in Advances in Water Resources and "Accounting for non-stationary variance in geostatistical mapping of soil properties" which is under review.

The codes are available on Github.

Tool to advise on using appropriate river pollutant transport model

This software tool has been developed to enable evaluation of structural and parameter uncertainty in models to describe pollutants in rivers. This tool can therefore assist in selecting appropriate river pollutant transport models.

The tool is written in Python and described in Deliverable 4.7 and the code is available as a zip file from the QUICS site.

Mon, 27 Jan 2020 10:41:00 -0600 en text/html
Killexams : Leo Cole

Leo Cole is responsible for the strategy and execution of the Trustwave's information security solutions business. He has more than 30 years of experience in technology marketing and information security, having held leadership positions at IBM, Websense, and Guidance Software. He was previously Vice President of Marketing at digital forensics and electronic discovery vendor Guidance Software. Directly prior, he was Vice President of Marketing at Websense. Leo also spent more than 20 years at IBM in various positions defining and building new markets, as well as successfully managing existing businesses. He earned his Bachelor's degree in computer science from Syracuse University and holds a Master's degree in business from the University of Tennessee, Knoxville.

Tue, 20 May 2014 04:06:00 -0500 en text/html
Killexams : SCOUT wins defense contract to demonstrate utility of commercial data from sensors in space

The company developed a sensing payload that would supply spacecraft 'eyes to enable better navigation and avoid threats'

WASHINGTON — Startup Scout Space won a Phase 2 Small Business Innovation Research contract from the U.S. Space Force to augment military systems with commercial data from space-based sensors, the company announced July 22.

The $750,000 award allows the company to continue software-development work started last year under an SBIR Phase 1 contract. Scout wants to demonstrate that commercial data collected by sensors in space combined with data from traditional ground sensors can Excellerate the accuracy of space debris tracking and can help predict collisions. 

The ability to augment the military’s space catalog with commercial data that can be shared with international allies is of growing interest to the U.S. Space Force, said Scout’s co-founder and CEO Eric Ingram. The company’s software will be tested by the operators from Space Delta 2, a Space Force unit that focuses on space domain awareness, and the Air Force Research Laboratory’s intelligence systems division.

The Alexandria, Virginia-based company, founded in 2019, developed a sensing payload called SCOUT Vision that would supply spacecraft “eyes to enable better navigation and avoid threats,” said co-founder and chief technology officer Sergio Gallucci. The payload uses computer vision and guidance software. The first one launched in June 2021 on an Orbit Fab’s on-orbit refueling spacecraft and is currently in operation. 

“Our first payload has been collecting data and we have been leveraging that data in our internal development, that data is just not part of this Phase 2 contract,” Ingram said. 

For the Phase 2 contract, the company will be using a simulated digital space environment, known as digital twin data.

Ingram said Scout plans to launch more vision sensors in upcoming missions, including two planned with the space transportation startup Momentus and others.

Gallucci said the key goal under the SBIR project is to make sure the data can be used on military systems. “Some within the Space Force are curious about, but uncertain, about what kind of data can be delivered on an unclassified basis,” he said. “U.S. and coalition allies have been challenged for years by the ability to share space situational awareness data. And that is one of the thrusts that we’re pursuing with the AFRL intelligence systems group.”

Col. Marc Brock, commander of Space Force Delta 2, said the Space Force has gaps in its space domain awareness enterprise “and we are always in pursuit of new capabilities to fill those gaps.” Having access to unclassified data and capabilities to automatically generate analytic products and services, he said, “have potential to become critical enablers for Delta 2’s mission.”

Fri, 22 Jul 2022 11:37:00 -0500 Sandra Erwin en-US text/html
Killexams : COTS Software: A Broader Picture


In the past decade, there has been a sea change in the business software domain. Many companies are no longer expending significant internal resources to develop software from scratch. Instead, they are opting for software that meets most or all of the business requirements as delivered “off the shelf” by a third party. Commercial off-the-shelf (COTS) software is an extremely broad category that encompasses software that can be purchased and used with minimal or no configuration. There are virtually unlimited types of COTS software. Some examples include resource planning applications, customer relationship management tools, and quality system databases for CAPA, complaint handling, auditing, and document control. It also comprises laboratory information systems, accounting software, and software embedded in medical devices.

There are many benefits to using COTS software. Foremost, it is the vendor that expends the resources to design, develop, test, and support the software. Often, the software vendor also has extensive expertise in the target market for the software and thus is able to incorporate functionality into the software to support best-practice methodologies. For certain types of COTS software, the vendor will also provide hosted software, which eliminates the need for the buyer to purchase and maintain servers and supporting hardware. Altogether, this can allow a company to implement tailored software more quickly and cost-effectively. But there are potential downsides to using COTS software as well.

One of the fundamental limitations of implementing COTS software is that a company typically does not have direct control over the software's feature set, including what functionality is added, changed, or removed with each release. As a result, the company may not be able to dictate the schedule for the incorporation of business- or compliance-critical functionality in the system. In addition, the release schedule of the software is also usually determined by the software vendor. The timing could lead to a forced upgrade of the software, either because the prior version is no longer supported or because the latest version will be pushed to all clients simultaneously, such as in a multitenant, hosted environment. Lastly, the company is reliant on the vendor for the software system's technical details, which can be critical to successful application integration and interfacing. Such details are also important for the troubleshooting and resolution of software issues that arise.

Although COTS software can virtually eliminate internal software development activities for a business, it presents a unique set of challenges and does not obviate the need to ensure compliance through software validation and procedural controls. One of the more common compliance challenges for businesses in the medical device industry is in the validation of COTS software. This article focuses on the validation of business and quality system COTS software. It also discusses other aspects of implementing such COTS systems that can have a significant effect on a company's business.

COTS Validation Decision

The first step in deciding whether to validate a COTS software system is to understand its intended use. Per FDA's General Principles of Software Validation guidance, software must be validated if it is used to achieve compliance with predicate rules (e.g., 21 CFR 820, 21 CFR 1271). The guidance states:

When computers or automated data processing systems are used as part of production or the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol.

FDA further states that “off-the-shelf software may have many capabilities, only a few of which are needed by the device manufacturer…When device manufacturers purchase ‘off-the-shelf' software, they must ensure that it will perform as intended in their chosen application.” This means that regardless of how the software vendor defines the intended utilization of the system, each business should independently define its specific use and ensure that this use is validated.

If a software system or functionality within the system is not used for compliance with FDA regulations, a company may not need to perform validation of the whole or parts of the system. In other words, the breadth of the validation is driven by the functionality used to comply with regulatory requirements. An example is an accounting package, which is used only to capture financial business transactions. Although the system is important to the business, the tracking of finances is not required by FDA regulations; consequently, FDA does not require it to be validated. Even so, some companies may choose to validate all software systems because it makes good business sense to ensure that systems operate per specifications and to set a consistent company expectation regarding software validation activities.

COTS Validation Approach

Once the high-level decision has been made regarding validation, there are two specific elements that need to be addressed: the system's actual compliance with applicable predicate rules, standards, and general regulations as well as its formal validation.

Although the software vendor may strongly assert that its application is compliant with FDA regulations and other standards, it is prudent for the device company to verify compliance. Ideally, this verification is performed before purchasing the system, but it absolutely must happen before moving the system to production use. Again, the system should be compliant with applicable elements of the predicate rule and should also adhere to 21 CFR Part 11 requirements.

In addition, a company may decide to demonstrate adherence to other industry standards such as ISO 13485. A compliance assessment should be performed for each applicable regulation and standard. Relevant elements of the applicable regulations and standards will also be incorporated into the system requirements so that they are validated. Upon moving the system to production use, it would render an entire validation effort meaningless if the system is not also compliant with applicable regulations and standards. Stated another way, validation establishes that the intended use of the system is satisfied, and the intended use inherently must include compliance considerations.

As an example, a complaint system used by a medical device company must be compliant with 21 CFR Part 820.198, which covers complaint files. The use of the system to approve and store official electronic complaint records would also necessitate compliance with 21 CFR Part 11. The specific subsections of Part 820.198 that are related to functions performed within the software are captured as requirements against which validation is performed. To limit downstream risk, a compliance assessment is performed at the time of software selection. If gaps are found during the compliance assessment, the company can use the findings to direct additional vendor development or configuration activities, or it can seek a different, more compliant product.

The basic methodology for validating COTS software involves the following activities, which are performed in concert with implementation tasks such as system configuration:

• Define company's use of the system, ideally including use cases and explicit clarification of in-scope and out-of-scope functionality.

• Determine validation deliverables set based on system type, system risk, project scope, and degree of system modification.

• Review the existing vendor system and validation documentation.

• Devise strategy for validation that leverages vendor documentation and systems as applicable.

• Create applicable system requirements specification and design documentation.

• Generate requirements-traceable validation protocol and execute validation.

• Establish system use, administration, and maintenance procedures to ensure that the system is used as intended and remains in a validated state.

If the vendor has documented system requirements, the company needs to assess them to ensure that its needs are met. If there are requirements beyond those documented by the vendor, the company needs to create a separate requirements document. The validation testing will then need to cover and trace to these requirements. If this scenario applies, the firm should determine whether any of the vendor requirements and testing can be leveraged toward its own validation. Remember that even if all the requirements are covered in the vendor and company documentation, it must be easy to trace and explain. Otherwise, it can be difficult to demonstrate compliance.

Vendor As Critical Business Partner

After covering the top-level aspects of COTS software selection and validation, it is almost equally important to assess the software vendor's supporting processes to determine the vendor's capabilities. This step can help ensure long-term satisfaction with the system. Unless a company purchases a single version of the software and never updates it, it must rely on the vendor's operations on a continual basis. Much of the total cost of ownership of a software system can be associated with production use and updates of the system after its initial implementation, so knowledge of a vendor's overall support capabilities and software update practices is critical. For this reason, companies must thoroughly evaluate a vendor both qualitatively and quantitatively, and preferably before any agreement has been reached. Use the selection process to thoroughly qualify the vendor. In addition to following standard supplier qualification processes, which take into account the risk and criticality of the software for a company, the following areas should also be considered.

General Responsiveness. Submit several requests for data during the selection process and meet with as many people as possible at the vendor to ascertain its level of engagement, commitment, and expertise. Does the vendor do what it says it will do? Be wary of vendors that don't admit to any deficiencies in their systems or operations. Be on the lookout for instances during the sales process where a prospective vendor incorrectly communicates the capabilities of the software or the support functions or doesn't follow through on commitments to provide more information. Communication problems during the sales and qualification process are unlikely to go away after a contract is signed; they often serve as a warning for future challenges.

COTS Degree. A company's relationship with the vendor will be somewhat dependent on the degree to which the software is off-the-shelf. For instance, word-processing software purchased at the local computer store has a different level of vendor support than an COTS quality system software product. The target consumer of the system dictates the level of personalized customer service provided, and recognizing the “degree of COTS” allows the implementation, validation, and maintenance paths to be charted appropriately.

Client Mix. Consider the vendor's mix of software clients (e.g., how many clients, whether they are large or small, which markets they serve, the percentage of clients in each market, etc.). This information can help determine the uniqueness of your company's use of the system. For financial reasons, the vendor logically shapes its software to satisfy as much of its client base as possible. The mix of clients and markets served dictates the future path of the software and support processes. Ideally, a company is similar to the majority of the vendor's clients in terms of functional and regulatory requirements that are satisfied by the system. Companies should understand the vendor's commitment to serve their market segment. If, for example, a company is small and has unique needs in a market segment to which the vendor is not committed, the company should assess competitive offerings from other vendors that may better match its size and specific needs.

Hosted Application Sharing. If the software system is Web-based and hosted, it is important to understand how many clients access the same hosted deployment of the application. The number of clients on a hosted deployment influences the flexibility the vendor has regarding software release dates and times. If it is important to have control over the production release of each new software version, a company should make arrangements to have a dedicated instance of the hosted application so that no other companies can influence the release schedule.

Software Update Frequency. Try to determine how often the vendor releases new software versions as well as whether each new release requires an upgrade. The typical release schedule dictates ongoing validation activities, which can significantly contribute to the total cost of ownership. This schedule should be taken into account for internal resource planning purposes. The best-case scenario is that a company can control whether and when system updates occur. Also, vendors will often apply bug fixes and hot patches to the software behind the scenes with little or no notice. These are changes to the system to fix glitches and should not change its intended use. Ideally, the vendor alerts the client to bug fixes and hot patches so that the company can assess how these elements affect software functionality. What the vendor deems an insignificant bug fix may be more than that to a client.

Software Update Previews. Companies should see whether the vendor is willing to provide a preview of each new release before it is moved to production. This is a key concern if the software is a hosted, Web-based product because the client often has little control over the timing of the production release of the software. Preproduction availability of the software allows a company to become familiar with new software functionality, evaluate its effect on the established intended use, and perform any necessary validation activities before the production release.

Software Release Notes. Detailed software release notes help a company assess whether and how a functional change to the software affects its use of the software. If there are multiple modules in the software and a company does not use or validate all of them, it is particularly important that the release notes break out changes by module. The vendor should also provide user and administrative documentation (i.e., manuals or help files) that walks through all aspects of system use as well as administrative functions to be performed by users.

Key Software Controls. In addition to the basic quality system elements that allow the software vendor to ensure the ongoing quality of its products and services, pay particular attention to the following processes: change control, configuration management, and environment deployment.

Change control ensures that software application updates are assessed and integrated in a systematic fashion. The vendor should be able to demonstrate how system change requests are logged, reviewed, and linked with a release, as well as how decisions are relayed to the requestor. Firms should ensure that the vendor understands the technical, regulatory, and business effects of each proposed change.

Configuration management controls the elements of the software system and its documentation so that they are identifiable and synchronized, and so that only approved versions are moved to production. If the vendor is performing technical configuration or customization to the system on a company's behalf, the vendor must be able to tightly control and deploy updates to the company's system. Besides reviewing procedures, there are other practical ways to assess the effectiveness of change control and configuration management. One method is to review the system change requests submitted by internal and external resources. The requests should be thoroughly documented and there should be evidence of review, disposition, and feedback for each request. The implemented changes should be linked to a version of the software.

Environment deployments are often the most difficult aspect of implementing and updating a database application. Discrete environments should be used for development, test, and production use. Configuration changes are typically made in development and promoted to the test and production environments. The promotion process needs to take into account, either automatically or manually, that there may be existing master data that should not be altered when updating the production environment. Using the test environment solely for acceptance and testing ensures that test or sample data are not included in an environment promotion.

Technical Troubleshooting and Root Cause Analysis. Inevitably, there will be problems with the software system that occur over time. As noted previously, a company is reliant on the COTS software vendor for the software system technical details. During the assessment, review previously reported issues and how they were resolved. The current software technology requires the coordinated performance of hardware, operating systems, vendor software, Web browsers, printer drivers, etc., so it is essential that the vendor not only demonstrate technical expertise across these interconnected domains but also a commitment to truly resolving technical issues that affect its customer base.

Part 11 Knowledge. Is the vendor aware of and well versed in 21 CFR Part 11? A vendor that is unfamiliar with Part 11, which covers electronic records and signatures, may make changes to the software over time that unintentionally affect its Part 11 compliance. (Note that not all COTS software is subject to Part 11 requirements.)

Software Configuration versus Customization

COTS software is typically configured by the client company. Configuration often involves activities such as adding system users, populating field drop-down lists, adding entities, etc. But it can also involve renaming data fields to allow the process to better match an existing client process. Software customizations, which are sometimes required to ensure compliance or to match a client's defined business process, involve branching the code from the base set. As a result, customizations frequently require additional development coding each time a new release of the software is installed, which can result in the expenditure of development resource time with each release and increase the time required to perform validation. Limiting client software changes to configuration allows the client to more easily upgrade the software with each new release.


Companies can use COTS software to tap into established industry best practices while avoiding the need to design and develop custom software. The upfront costs of implementation can also be reduced by selecting hosted, Web-based software package. However, using an outside software vendor includes giving up some level of control. To mitigate this risk, companies should perform upfront vendor assessment activities, including both qualitative and quantitative reviews.

In concert with a standard supplier quality assessment, a company should also understand key parameters such as the degree to which the software is off the shelf, the vendor's client mix and demographics, the vendor's approach to hosted software as applicable, the frequency of and communications related to software updates by the vendor, the vendor's key software controls, and its knowledge of 21 CFR Part 11. The software buyer is still responsible for ensuring compliance through software validation and procedural controls, so all of these factors should be taken into account when calculating the true cost of software ownership.


1. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (Rockville, MD; FDA, January 11, 2007).

Bryan Chojnowski is a director of quality for Reglera LLC (Lakewood, CO).

Copyright ©2009 Medical Device & Diagnostic Industry

Sun, 24 Jul 2022 12:00:00 -0500 en text/html
Killexams : How to Calculate the Dollar Value of Employee Benefits

Larry Simmons is a freelance writer and expert in the fusion of computer technology and business. He has a B.S. in economics, an M.S. in information systems, an M.S. in communications technology, as well as significant work towards an M.B.A. in finance. He's published several hundred articles with Demand Studios.

Tue, 17 Jul 2018 06:17:00 -0500 en-US text/html
Killexams : Graduate Careers

A master's degree in any of the programs offered by the department can lead to rewarding careers in many fields, including:

  • public and private-sector agencies in the criminal justice system at the federal, state, and local levels of government (MSCJ)
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  • forensic science and conventional analytical laboratories (MSFS)
  • administration of criminal justice or juvenile justice systems (MSCJ/MPA)
  • cybercrime investigation or computer forensics examination (certificate program)

Each of our programs is also a good place to build a strong foundation for doctoral and professional studies.

What Are Our Graduates Doing Now?

Alumni of our programs have gone on to earn advanced degrees at some of the highest ranked doctoral training programs in the US, to have very successful careers in government; and to stellar careers in business and industry. You can find graduates of our programs at the following companies and agencies:

  • Alabama Department of Forensic Sciences
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Career Resources

courthouseThere are many resources available to help you start or advance your career.

The University's Career Center is a great place to get started. The Center provides information on employment opportunities; assists with job skill development — including interviewing and resume writing; sponsors jobs fairs; and much more! Be sure to check out the information and advice tailored specifically for you.

You can research your job prospects through the Department of Labor's Occupational Outlook Handbook, which describes working conditions, training and education needed, and expected earnings and job prospects in a particular field. You can also visit USA Jobs for a listing of positions available with the federal government.

Fri, 08 Sep 2017 16:31:00 -0500 en-US text/html
Killexams : U.S. agrees to send Ukraine more HIMARS launchers, weaponry that is taking a toll on Russian forces

To hear Ukrainian military officials tell it in exact days, the indispensable weapon in month five of their defensive war against Russian invaders is the High Mobility Artillery Rocket System, or HIMARS, an armored-vehicle-mounted long-range artillery launcher.

“HIMARS have already made a HUUUGE difference on the battlefield,” tweeted Ukrainian Defense Minister Oleksii Reznikov on July 9. “More of them as well as [U.S.] ammo & equipment will increase our strength and help to demilitarize the terrorist state,” he wrote, referring to Russia.

So it no doubt came as gratifying news in Kyiv that Defense Secretary Lloyd Austin confirmed Wednesday that Washington would send another four HIMARS platforms, which, he added, Ukraine has been “using so effectively and which have made such a difference on the battlefield.”

Secretary of Defense Lloyd Austin at a Pentagon briefing on Wednesday. (Alex Brandon/AP)

HIMARS strikes have indeed been devastating, and the Russian military simply has no counter for their range, accuracy and mobility; the M31 series rockets that have been supplied with the HIMARS have the ability to hit a target within a 16-foot radius at a range of 52 miles. Because it’s on wheels, the launcher can be on the move seconds after firing, making it incredibly well protected against Russian counterbatteries.

Since the U.S. began supplying HIMARS in late June, the Ukrainians have managed three things simultaneously. First, according to Valery Zaluzhny, commander in chief of the Ukraine Armed Forces, their use has been an “important contributing factor” in “stabiliz[ing]” the front in the Donbas region, where Russia had been making slow but unmistakable gains, including capturing the sister cities of Severodonetsk and Lysychansk. The situation there, Zaluzhny said, is “complex, tense, but completely controllable.” (Contrast that sanguine tone with the catastrophic losses in manpower that Ukrainian officials, including President Volodymyr Zelensky, were citing just weeks ago, when 100 to 200 Ukrainian soldiers were being killed per day.)

A High Mobility Artillery Rocket System, or HIMARS, at a Marine Corps base camp in Jacksonville, N.C. (Lcpl. Jennifer Reyes/U.S. Marines/Planet Pix via ZUMA Press Wire)

Scores of Russian ammunition depots deep inside occupied parts of the Donbas have now gone up in smoke on a near daily basis in the last few weeks, prompting a host of new memes on Twitter and war watchers to routinely refer to the arrival of “HIMARS o’clock.” These strikes have been so punishing to the Russians' efforts to resupply their own artillery systems, which far outnumber the Ukrainians’, that Moscow announced an operational “pause” in its campaign in the Donbas on July 7.

Russian Defense Minister Sergei Shoigu ordered generals to prioritize destroying the HIMARS and other long-range artillery during a visit to the front in Ukraine on July 18, a tacit acknowledgment of how significant their impact has been.

Second, HIMARS helped Ukraine recapture the strategically vital Snake Island, in the Black Sea, scene of the famous retort to a Russian battleship from a besieged Ukrainian soldier, “Russian warship, go f*** yourself.” Even though not directly used against Russian positions on the island, the very presence of HIMARS weapons on the battlefield, in conjunction with Western-supplied anti-ship missiles such as Harpoons, has weighed heavily in Russia’s strategic calculation that holding the island would prove impossible in the long term.

A high-ranking Ukrainian military intelligence official told Yahoo News that Russia’s withdrawal from Snake Island, which the Kremlin tried to spin as a “goodwill gesture,” demonstrated a “real fear of our new long-range artillery capability.”

A satellite image shows smoke rising from Snake Island, off the coast of Ukraine, on June 29. (Planet Labs PBC/Handout via Reuters)

“We’ve hugely expanded our range of operational control over the Black Sea coast, and we’ve stopped the Russians from conducting amphibious operations in this area,” the official, who requested anonymity, said.

The official added that Russia’s hasty pullback has yielded a bonanza of actionable intelligence and matériel for Ukrainians. “Our team was able to find ammunition, different types of weapons, combat and personnel documents and even packed-up-and-ready-to-use aerial reconnaissance systems that the Russians absolutely need,” the official said.

Third, HIMARS has allowed Kyiv to prepare for an upcoming counteroffensive in the southern region of Kherson, the first major population center to fall to Vladimir Putin’s forces since the Russian invasion was launched on Feb. 24.

On July 11, HIMARS destroyed a Russian command center at the serially pummeled Chornobaivka Airport, killing 12 senior Russian officers, including Maj. Gen. Artem Nasbulin, chief of staff of the 22nd Army Corps, according to Serhiy Bratchuk, a Ukrainian official in the Odesa regional military administration.

This is an impressive troika of accomplishments for any weapons platform in just under a month of operations, especially given how few HIMARS launchers there are in Ukraine.

The United States supplied an initial four systems on June 23. In what is now a familiar “proof of concept” pattern of American security assistance, more were approved once the Ukrainians demonstrated their effectiveness on the battlefield.

A Ukrainian military commander with the rockets on a HIMARS vehicle in eastern Ukraine. (Anastasia Vlasova for the Washington Post via Getty Images)

As of July 20, a total of 16 U.S.-supplied HIMARS systems are either in the country or on their way, in addition to European equivalents: The Ukrainians have been purposefully ambiguous on how many systems are active for reasons of operational security. The U.K. has pledged six of the M270B1, an even more powerful version of the HIMARS, of which three have already arrived, and the Germans have committed three MARS II MLRS, another HIMARS cousin, that are due to arrive at the end of July. In total, Ukraine will soon take possession of 25 long-range Western artillery systems.

Reznikov, the Ukrainian defense minister, said at a July 19 event hosted by the Washington, D.C.-based think tank the Atlantic Council that Ukraine needs double that number to deter Russia, and quadruple it to wage any successful counteroffensive.

For Ukrainian troops who have long complained about Russian artillery supremacy in the Donbas, the arrival of HIMARS and its European equivalents would prove a much-needed shot in the arm, Ukrainian military officials say. For Ukrainian civilians, the weaponry delivered to date has meant a respite from unremitting carnage. The United Nations assesses that 4,731 civilians have been killed and 5,900 have been injured.

Originally designed to monitor forest fires, NASA’s Fire Information for Resource Management System (FIRMS) satellite network has been used throughout the war by professionals and amateurs alike to chart the blazes that have resulted from artillery fire. All the exact FIRMS data points to a large reduction in Russia's activity along the line of contact as its heavy guns and multiple rocket launchers well beyond that line are destroyed in nightly HIMARS attacks by Ukrainian forces.

One of the key features of the HIMARS system is its modular nature, giving it the ability to fire a range of different rockets. In addition to being capable of firing M31 rockets, the system can fire one of the larger and more destructive Army Tactical Missile Systems (ATACMS) ballistic missiles.

An Army Tactical Missile System in action. (U.S. Army via Wikicommons)

With a range of up to 186 miles and the same pinpoint accuracy of M31, the United States had held off supplying ATACMS to the Ukrainians for fear they would be used to strike targets within Russia itself and set off an escalatory spiral that could drag NATO countries and Russia into a direct conflict.

President Biden appeared to rule out sending ATACMS to Ukraine in a May 31 New York Times op-ed in which he emphasized the limits to American military support.

“We are not encouraging or enabling Ukraine to strike beyond its borders,” he wrote.

Of late, however, fears that Ukraine would use long-range artillery to attack targets inside Russia seem to have subsided. Kyiv has stuck to its agreement with Washington not to use HIMARS to hit inside Russia. And Reznikov recently told the Financial Times that he was confident Ukraine would eventually receive the ATACMS tactical ballistic missile.

If the U.S. does decide to send ATACMS, that too could fundamentally change the course of the war, putting the Kerch Bridge — Russia’s only direct connection to the occupied Crimean Peninsula — and the Sevastopol Naval Base, home to what remains of its Black Sea Fleet, well within striking distance.

Kaimo Kuusk, the Estonian ambassador to Ukraine, told Yahoo News that the Russians have already grown skittish over Ukraine's long-range fire capability, as evidenced by the relocation of a “significant number” of ships in the Black Sea Fleet from its home port of Sevastopol in Crimea to Novorossiysk in southern Russia. “As the Ukrainians advance, Sevastopol will be within reach, and Moscow cannot afford another humiliation like the sinking of the Moskva,” Kuusk said, referring to Ukraine’s sinking of the flagship Russian cruiser on April 14 with domestically manufactured anti-ship missiles.

The South Korean military launches an Army Tactical Missile System during a military exercise. (Defense Ministry via Zuma Press Wire)

Maj. Gen. Volodymyr Havrylov, Ukraine’s deputy defense minister, told Yahoo News that the relocation could well be Moscow’s way of hedging its bets against heavier-duty artillery being sent to Ukraine. Asked if the Black Sea Fleet was quitting Crimean ports in anticipation of ATACMS, Havrylov responded, “I think so.”

According to Thomas Theiner, a former artillery specialist in the Italian army, ATACMS would dramatically worsen Russia’s growing strategic nightmare. “These missiles are 100% accurate up to a range of 186 miles,” he said, adding that the two most exact ATACMS versions, the M48 and M57 with the WAU-23/B warhead, carry 216 pounds of high explosives, “making them ideal to take out things like bridges.” The Russians, moreover, can’t intercept these rockets, which travel at more than three times the speed of sound, because their guidance software varies their flight patterns to confuse enemy air defenses.

ATACMS can eliminate even Russia’s best air-defense platform — the S-400 — and apart from destroying ammunition depots and command centers, they could also wipe out stocks of Kalibr cruise missiles stored in Crimea, which the Russians have fired on Ukrainian cities, often in retaliation for military losses.

“Even if the U.S. forbids the Ukrainians from targeting the Kerch Bridge,” Theiner said, noting that it could be interpreted as an attack on infrastructure that extends into Russian territory, “a few kilometers from it is a rail tunnel, which ATACMS can easily destroy by hitting it from either end. It would spell the end of all Russian logistics in the peninsula.”

The Ukrainians appear to be preparing the battlefield for a counteroffensive just north of Crimea. They struck the Antonovskiy Bridge in Kherson Oblast twice, on July 20 and 21, the second time forcing the Russians to close the bridge for repairs. The bridge is the main road link across the Dnieper River and a key artery for the logistics and reinforcements flowing to Russian occupiers in Kherson.

Ukrainian artillerymen checking equipment before advancing to the frontline in Kherson, Ukraine. (Metin Aktas/Anadolu Agency via Getty Images)

These preliminary strikes are believed to be largely symbolic, and the Antonovskiy Bridge was not heavily damaged. A former Western intelligence official told Yahoo News that hitting it twice was “an attempt to put psychological pressure on the Russians, to make them afraid that at a certain point they won’t be able to evacuate their troops from the west bank of the [Dnieper].”

“If we take for granted that in the event the Russians leave Kherson, they’ll destroy the two bridges crossing the river anyway,” the ex-official said, and added, “The Ukrainians may think it’s better not to supply them a chance of a more or less controlled withdrawal.”

Pro-Russian military commentators on social media have grudgingly admitted that Ukrainian artillery strikes run the risk of making the bridge unusable for heavy military traffic, assuming it isn’t collapsed completely. The highly trafficked “Starshe Eddy” channel on Telegram was downright envious of Ukraine’s new capability and determination.

“The Armed Forces of Ukraine are doing what we should have done a long time ago, namely, they are destroying the bridge across the Dnieper in Kherson. The goal is obvious, to interrupt military logistics between the left bank and our foothold on the right bank,” a exact message read. “It is difficult to physically destroy the bridge itself, but to make its work impossible or extremely difficult is quite a feasible task. To do this, they will strike every day, preventing repair teams from restoring what was destroyed. Why we don’t do the same with the Ukrainian bridges across the Dnieper, I don’t understand.”

For the Ukrainians, the upcoming push in the south, which Reznikov has claimed will be made up of “a million-strong army,” has been given new impetus by Russian designs, according to U.S. intelligence, to hold sham “referendums” and then annex occupied Donbas territories à la Crimea. Russian Foreign Minister Sergey Lavrov appeared to confirm those plans in an interview with Russian state media on July 20. “Now the geography is different,” he said. “And it is not only [Russian-occupied areas in Donbas] but also the Kherson region, the Zaporizhzhia region, and a number of other territories, and the process continues, and it continues consequently and persistently.”

Tellingly, Lavrov specified that “if the West delivers long-range weapons to Kyiv, the geographic goals of the special operation in Ukraine will expand even more,” in a further indication of just how seriously Moscow views these weapons systems.

With additional reporting by James Rushton in Kyiv


How are Ukrainian forces taking out so many Russian tanks? Use this embed to learn about some of the weapons systems the U.S. is sending to the Ukrainian army.

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