Biomedical Engineering Reference
In-Depth Information
means that the regulated company may need to validate with broader
scope and greater rigour than would otherwise be the case. This is likely
to increase the cost of validation, which will offset some of the cost
savings inherent in the use of open source software. This is why this
needs to be assessed after the package and 'supplier' assessment - to
confi rm that the fi nancial advantages for using open source software are
still valid, despite the cost of validation.
21.7 Ongoing validation and compliance
Once the software has been initially validated, it is essential that it is
maintained in a validated state and subject to periodic review and, in the
case of any changes, appropriate re-validation (which may include regression
testing of unchanged functions). This follows well-defi ned principles and
processes best defi ned in the GAMP
®
Good Practice Guide 'A Risk-Based
Approach to Operation of GxP Computerized Systems'. Once again, the
use of open source software does not provide a rationale for not following
the processes defi ned in this guidance document, which are:
■
handover;
■
support services;
■
performance monitoring;
■
incident management;
■
corrective and preventative action;
■
operational change and confi guration management;
■
repair;
■
periodic review;
■
backup and restore;
■
business continuity;
■
security;
■
system administration;
■
data migration;
■
retirement, decommissioning and disposal.
It is, of course, acceptable to scale these processes based on the risk
severity, size and complexity of the open source software.
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