Biomedical Engineering Reference
In-Depth Information
equivalent to the production environment and that testing in the test
environment is representative of the production environment. Release of
tested software should also be subject to defi ned version, release and
change management processes and will again be on a less frequent basis.
Although it is possible to 'fast track' new functions, the need to regression
test existing, unchanged functionality places limits on exactly how fast
this can be achieved. The production instance should, of course, also be
qualifi ed.
21.8 Conclusions
The validation process and controls described above apply only to
validated open source software - those supporting regulatory signifi cant
processes or managing regulatory signifi cant data or records. Non-
validated open source software does not always need such control,
although the prudent mitigation of business risks suggests that appropriate
processes and controls should nevertheless be established.
The use of open source software does provide a number of advantages
to life sciences companies and these include speed to implement new
solutions, the ability to deploy ground-breaking software and the
opportunity to participate in and benefi t from a broad collaborative
community interested in solving similar problems. However, the need to
assure regulatory compliance and the requirement to validate and control
such software does bring additional costs and add time to the process.
Although this should not completely negate the advantages of open
source software, the cost- and time-saving benefi ts may not be as great as
in other non-regulated industries. Life sciences companies should
therefore ensure that initiatives to leverage open source software are
properly defi ned and managed, and that the relevant IT and QA groups
are involved at an early stage. This will allow relevant package and
supplier assessments to be conducted and the true costs and return on
investment to be estimated.
Although much of the validation process is similar to the process used
to validate commercial software, the nature of open source software
means that there are some important differences, and the use of
experienced subject matter experts to support the validation planning is
highly recommended. Effective controls can be established to maintain
the validated state and this will again require a common understanding
of processes and close cooperation between the process owners (users),
system owners (IT) and QA stakeholders.
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