Commercial off-the-shelf software

Category 3—Standard Software Packages These are commercial, off-the-shelf software packages. The package is not conhgured, and process parameters may be input into the application. The name and version should be documented and verihed during IQ. Compliance to URS should be tested during QQ. Supplier documentation should be assessed and used. 

Networks are largely made up of standard components (system software, firmware, and standard software) there is little bespoke programming other than configuration and perhaps some specialist interfaces. Supplier audits for Commercial Off-The-Shelf software are not normally required, as discussed later. 

It is useful to understand the steps of the software development life cycle (SDLC) during a project. In fact, this approach is commonly used for implementation and validation even when commercial off-the-shelf software is involved [104]. It is also important to consider the economic aspects of the automation project [105]. A 10-step guide to success that emphasizes clearly defined project control in outsourced automation/information technology projects has been published [106]. 

Software architecture used in discovery informatics is characterized by its diversity. It is rare to find an environment used in target identification and validation that consists solely of commercial off-the-shelf software. In most cases the research environment consists of a variety of commercial, open-source, and locally developed software packages. HTML and Web technologies are often used as a mechanism to integrate these disparate environments. One aspect of research IT is its datacentric nature, often involving a wide variety and types of data in unstructured and semis-tructured textual forms and in structured forms as relational and object-oriented... 

DO-278A is a variant of DO-178C aimed at CNS/ATM systems. These are groimd-based, rather than airborne, systems. These systems typieally make much more use of commercial off the shelf software (COTS), especially operating systems and databases, than do airborne systems. DO-278A defines six software levels (ALl to AL6), as compared to five in DO-178C (Level A to Level E). 

Components sourced from other companies that use Previously Developed Software (PDS) This issue most often arises due to the purchase of sensors and actuators which have embedded software - the so-called Smart Sensor problem. The difficulty here is that the pedigree of the PDS may be unknown, or the quality control system used by the supplier company may be considered inadequate, or else the supplier company may be reluctant to divulge information about the software because they consider it threatens their Intellectual Property (IP). Acronym alert Software-based devices can also be known as COTS devices - since they use Commercial Off The Shelf software, as opposed to bespoke software. Software whose origins are unknown can be called SOUP - Software Of Unknown Provenance. 

Current computerized analyses of adverse events still typically consist of a vast number of discrete, often personal, ad hoc processes that mimic paper and pencil methods. Some commercial-off-the-shelf (COTS) software tools (e.g., Adobe Acrobat , Microsoft Word , Excel ) do have the capability to search for specihc terms in electronic documents/case reports and do have navigational tools with hyperlinks and fullfull-text indexing that enable researchers to create their own hyperlinks. Some other COTS software tools (e.g., SAS , Excel , Access , IMP ) allow importation of electronic case report tabulations (ECRT) for more detailed analysis. 

Standard software packages are called canned or COTS (Commercial Off-The-Shelf) configurable packages. The qualification of standard software packages is performed according to normal software installation and operational qualification practices. (Refer... 

An Outline Specification is usually required to sanction a project and authorize the allocation of a budget. It typically presents the business case for the computer system, defining key functionality and compliance requirements. This document may be used later on for developing the User Requirements Specification (URS) as discussed in Chapter 7. Where Commercial Off-The-Shelf (COTS) software and systems are being acquired, this document may be used as the URS. Outline Specifications must be reviewed and approved. 

Standard Software Commercial Off-The-Shelf Used in complex or critical Not applicable... 

When we speak of validating a database such as Oracle , we are talking about validating the database application, not the DBMS. The actual DBMS should be qualified as a Commercial Off-The-Shelf (COTS) software package. GAMP 4 recommends the following activities for this category of software ... 

Standard software packages are called canned or COTS (commercial off-the-shelf) configurable packages in the United States. Examples include Lotus 1-2-3 , Microsoft Excel and other spreadsheet packages. There is no requirement to validate the software package however, new versions should be treated with caution. Validation efforts should concentrate on the application, which includes... 

A proposed acceptance process for commercial-off-the-shelf (COTS) software in reactor applications, Lawrence Livermore National Laboratory, UCRL-ID-122526, 1995... 

Reuse of requirements models. We expect that in many domains of application, we will see the development of reference models for specifying requirements, so that the effort of developing requirements models from scratch is reduced. This will help move many software projects from being creative design to being normal design, and will facilitate the selection of commercial off-the-shelf (COTS) software. 

Implementing commercial-off-the-shelf (COTS) PLM software as a so-called team data management system appears to be very useful if some or optimally all of the following assumptions are true ... 

Both lEC 61508 and DEF STAN 00-55 mandate software development processes, with the implication that following the prescribed development process is essential to developing software of the required integrity. The use of Commercial off-the-shelf (COTS) software is increasingly prevalent in safety-related systems. However, the approaches prescribed by lEC 61508 and DEF STAN 00-55 cannot be used for COTS software, for which the system developer has little or no control over the development processes adopted. Furthermore, source code may not be available for COTS software, and hence many of the verification techniques recommended cannot be used. 

Application software is the software written to get the machine to perform a particular task. The way it is written and what it can do will depend on the design of the software. Most application software is developed as part of a system development program. Some applications software is provided by commercial off-the-shelf (COTS) software. 

See Commercial Ojf-the-Shelf (COTS), Commercial Off-the-Shelf (COTS) Safety, and Software Reuse for additional related information. 

Commercial Off The Shelf Products (COTS). Where the medical device being incorporated in the network makes use of the services of netwoik COTS products, typically security or backup/archive packages, there will be a need to examine the likely scenarios where the COTS failure would preseut a hazard to the correct operation of the medical device. The manner of dealing with what is described alternately in the broader safety industry as SOUP (Software of Uncertain Pedigree) is discussed in the following sectiom... 

Depending on the size of the CRO and the nature of the trial, the system may be acquired in one of the following ways (1) developed in-house by the organization s staff with off-the-shelf commercial software, (2) outsourced to outside contractors, (3) with open source/free software (OSS/FS), and (4) purchased from e-clinical proprietary vendors. 

The first contact that many scientific users have with neural networks is through commercially available software. The manuals and Help systems in off-the-shelf neural network software may not offer much on the principles of the method, so, on a first encounter, ANNs might appear to be black boxes whose inner workings are both mysterious and baffling (Figure 2.3). 

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