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09MA Roemer PDF
09MA Roemer PDF
This article
presents the Using GAMP 5 for Rapid Deployment
implementation
of a risk-based
approach into by Markus Roemer and Hermann Schaefer
a supplier’s
Software
Development
Workflow
and Product’s
Introduction
T
increased efficiency of operations, driving down
Release the costs, and improving data flow through the
he current IT solution landscape of a typ-
Management ical organization is comprised of many enterprise making data available wherever
according to system components, and may include needed.
GAMP® 5. Enterprise Resource Planning (ERP), If automation of the business process is a
Manufacturing Execution Systems (MES), key driver, why reduce the resulting benefits
Laboratory Information Systems (LIMS), as well by applying a diverse IT landscape which in-
as various automation solutions including: Dis- creases cost of IT operation and increases risk
tributed Control System (DCS), Programmable of compliance based on complex interfaces?
Logic Controller (PLC), Supervisory Control The answer may be that traditionally the sys-
and Data Acquisition (SCADA), and Human tems were focused on particular functionality
Machine Interface (HMI), etc. Traditionally, the and thus could not always meet a broader set
search for the best solution has primarily been of business requirements, hence the need to
driven by the functional match of possible solu- purchase disparate systems to meet all require-
tions against the organization’s requirements. ments. However, that situation is changing
The result in most cases is a diverse, multi and more healthcare companies are defining
faceted solution landscape, where components their IT landscape based on the “best-in-class”
are provided by different software vendors based model, where solutions are selected that may
on their individual technologies, also referred to not always provide the best functionality for a
as “best-of-breed.” These various systems also particular process (“best-of-breed”), but that
may be connected using a variety of interfaces. are superior over a broad range of functional
This situation poses several challenges for the aspects, including homogeneous infrastructure
healthcare industry, including significant costs aspects and technological innovation.
for providing the appropriate IT infrastructure,
development of interfaces to synchronize the Market Trends and
various solutions, which in most cases becomes Customer Needs
a focus of compliance activities, and last but not From a user’s perspective, the ideal world would
least, the maintenance and support costs. be to have one solution to meet all of their re-
IT solutions are utilized for many reasons, quirements and ideally one technology platform
and among them the automation of the business to host the entire solution.
process is a significant driver, with the aim of Over the years, both ERP and automation
Figure 1. Release
management.
Reprinted from
PHARMACEUTICAL
ENGINEERING®
The Official Magazine of ISPE
March/April 2009,
Vol. 29 No. 2
Before After