Validation and regulatory compliance of free/open source software - Open Source Software in Life Science Research - page 473

21

Validation and regulatory compliance
of free/open source software
David Stokes

Abstract: Open source systems offer a number of advantages, but
the need to formally validate some open source applications can be
a challenge where there is no clearly defi ned 'software vendor'. In
these cases the regulated company must assume responsibility for
controlling a validated open source application that is subject to
ongoing change in the wider software development community. Key
to this is knowing which open source applications require validation,
identifying the additional risks posed by the use of open source
software and understanding how standard risk-based validation
models need to be adapted for use with software that is subject to
ongoing refi nement.

Key words: validation; verifi cation; GAMP ® ; risk; compliance.

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21.1 Introduction

There is no doubt that the use of free/libre open source software (FLOSS)
can offer some signifi cant advantages. Within the life sciences industry
these include all of the advantages available to other industries such as
the ability to use low or no cost software, but the use of open source
software can also provide:

■ the ability to access and use new and innovative software applications
in timescales that can be signifi cantly advanced when compared to
software developed by commercial vendors;