Validation and regulatory compliance of free/open source software - Open Source Software in Life Science Research - page 477

applications which are at the leading edge of functionality and which may
offer signifi cant advantages to a life sciences organisation.
In most cases it is the regulated company which is not only accountable
for the validation of the open source application but must also assume
day-to-day responsibility for ensuring that the application is regulatory-
compliant, for validating the application and for maintaining the
application in a validated state with respect to their own operational use
of the software. In the case of the same instance of open source software
used by multiple regulated companies (e.g. Software as a Service running
in a community cloud), it is theoretically possible for a number of
regulated companies to form their own open source community and
share responsibility for the validated state of the shared software, but this
is a relatively new and untested model.
21.4 Validation planning
As with any software or application, the validation process starts with
validation planning. Many regulated companies have resources to address
this in-house, whereas small to medium organisations may prefer to take
the acceptable step of using qualifi ed third parties such as consultants.
Thorough and thoughtful validation planning is the key to successfully
validating open source software. The use of open source software is
different from the validation of commercially developed and supported
applications, and the validation planning should be undertaken by
experienced resources that understand and appreciate the differences and
can plan the validation accordingly.
￿ ￿ ￿ ￿ ￿
21.4.1 Package assessment
Validation planning should start with an assessment of the open source
software package (Figure 21.1) and will ask two important questions.
■ Does (or can) the application deliver functionality that complies with
our regulatory requirements?
■ Is it possible to cost-effectively validate the open source software in
our organisation?
Like commercial software, open source software can be categorised as
GAMP ® software category 1, 3, 4 or 5 or a combination thereof (see
Table 21.1).