COTS software

Commercial Of The Shelve (COTS) software is software that is available from suppliers and distributed to many users. The opposite of COTS software is customer made software. In this section we speak about software for manufacturing automation, like MES, DCS, LIMS and SCADA / PLC software.

In general with custom made software:

  • The exact required functions are available
  • Full validation may be required (GAMP software category 5)
  • No development of software
  • knowledge about the software may disappear from supplier
  • in case hardware is replaced after 3 to 5 years Microsoft may have decided to switch to a new Operating System, while the previous OS version does not support the new hardware. This may result in modifications to the custom made software and validation and ....

In many cases COTS software is available for the same functionality. The requirements will not always fit 100%, but there is a fit for the most critical requirement. At the same time more functionality is available that is not directly required, but maybe in the near future.

Main advantages for this type of software are:

  • The software is used by multiple companies. Validation reports may already be available
  • Less validation, since most of the software is defined as GAMP software category 1 or 3.
  • Software used by many users. Errors detection is high.
  • New versions of the software are developed, also for new versions of Windows. This makes future upgrades easy.
  • New features are developed in the software. This allows the user to grow in automation level in the future.
  • Knowledge about the software is maintained by the supplier.

 Keep in mind that the application (configuration) of the software may require intensive validation. Most of the application software can be defined as GAMP category 4 software and in some cases as GAMP category 5.