Biomedical Engineering Reference
In-Depth Information
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the ability to collaborate with other industry specialists on the
development of software to address the general non-competitive needs
of interest to the industry.
As signifi cant changes are taking place within the life sciences industry
(such as the move towards greater outsourcing and collaboration, the
greater need to innovate and reduce the time to bring products to market),
these advantages can be particularly benefi cial in areas such as:
■
the collaborative development of drug candidates by 'Big Pharma'
working with smaller biotechnology start-ups and or academia (using
open source content management and collaborative working) solutions;
■
the development of innovative medical devices such as
pharmacotherapeutic devices or devices using multiple technologies
using open source design, modelling and simulation tools (e.g.
Simulations Plus [1]);
■
the collaborative conduct of clinical trials including the recruitment of
subjects using open source relationship management software (e.g.
OpenCRX [2]) or cloud-based social networking tools such as
LinkedIn [3];
■
the analysis of clinical trial data, the detection of safety signals from
adverse events data and the monitoring of aggregated physician
(marketing) spend data using open source statistical programming and
analysis tools;
■
the development of process analytical technology (PAT) control
schemes, facilitated by open source data analysis and graphical display
tools;
■
the analysis of drug discovery candidate data or manufacturing
product quality data, using open source data analysis tools (e.g. for
mass spectrometry, see Chapter 4).
21.2 The need to validate open
source applications
When such applications have a potential impact on product quality,
patient safety or the integrity of regulatory critical data, some of these
advantages can be offset by the need to appropriately validate the software.
There is a clear regulatory expectation that such applications are
validated - stated in national regulations (e.g. US 21CFR Part 211 [4]
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