COTS, commercial-off-the -shelf

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... 

These tools are designed rather for lower EALs and can be useful for commonly used products, like COTS (commercial off-the-shelf). 

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... 

Commodity cluster A cluster consisting of computer nodes and network components that are readily available COTS (commercial off-the-shelf) systems and that contain no special-purpose components unique to the system or a given vendor product. 

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

The final section addresses developments in safety methods, looking in particular at the challenges posed by the increasing nse of COTS (Commercial Off The Shelf) components in safety-critical systems, and at hazard management. 

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. 

The Fido technology is currently under evaluation for use by U.S. military forces. The Fido X and Fido XT are available as commercial off-the-shelf (COTS) items. Consequently, the technology is adequately mature for commercial deployment. However, as a platform technology, the AFP sensor and Fido detection system support broad application to meet explosives detection needs. Further, Nomadics has incorporated the amplification features of AFP into other sensor mechanisms aimed at the detection of analytes that are not explosives related, including other chemicals and compounds of interest in the biomedical and food safety fields. Thus, while the technology is mature enough for commercialization, its potential is far from fully exploited. 

Most of the instruments used in the laboratory are commercial off-the-shelf (COTS) instruments, and consequently the users have little or no input into their design. A full system development life-cycle (SDLC) approach [8], which is used to develop complex computerized systems such as Laboratory Information Management System (LIMS) or Chromatographic Data System (CDS) or custom design laboratory equipment, is not appropriate for COTS instruments. Some laboratory instruments such as a pH meter or centrifuge are fairly simple and therefore do not warrant the SDLC approach. 

What if you are implementing a commercially available application (commercial off-the-shelf, or COTS application) rather than designing a custom application Do you still need these documents Yes, but probably not all of them. The FDA has made it clear [3] that URS are expected, even for COTS applications. Without a URS, there wouldbe no definition or required system functionality on which to base initial validation activities. The COTS URS will typically end up as a blend of the URS and FRS, as described previously. This blend of requirement types is appropriate for the COTS situation, in which you are specifying what is necessary for your business operations but do not need to write specifications sufficient to actually design the application from scratch. After selection of the application, additional specification... 

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. 

The computer systems used within each of these levels tend to have common characteristics that will influence their validation. For instance, measurement and control systems are generally configurable Commercial Off-The-Shelf (COTS) instruments. Examples include control instrumentation, analytical instrumentation, and medical devices including blood processing systems. 

In 1992, the decision was taken to introduce an EBRS in the galenical production of the pharmaceuticals division of F. Hoffmann-La Roche Ltd. in Basel, Switzerland. The project was launched as PK System in August 1994. By mid-1996, a major part of the system was in operation and working as intended. Back in 1992 there were no commercial systems available for this detailed functionality. Today there are several competitors working in this field. Some of the most important ones are Consilium, ProPack Data, SAP, and Werum. The implementation of a Commercial Off-The-Shelf (COTS) solution would have been the preferred option. 

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 ... 

Commercial Off-The-Shelf (COTS) Products Versions of products that have been commercially available for at least 6 months and are widely used. Beta releases of products that are still under supplier evaluation and COTS products specifically customized (rather than configured) for application are excluded from this definition. [Defined for this book.]... 

S. Arney, Design for reliability of MEMS/MOEMS for lightwave telecommunications, in Proc. 2nd International Conference COTS MEMS 2001 (Advances in Application of Integrated Commercial Off-The-Shelf Microelectromechanical Systems), Quincy, MA, USA (2000). 

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

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