Information and Knowledge Management using ArcGIS ModelBuilder

Bartosz Wachnik
logistics, where fulfilling requirements for quality standards is obligatory. Lack of an appropriate ERP
system can prevent an enterprise from functioning in the market.
Strategy related to the need for rapid innovative achievement treats an ERP system implementation
as an instrument helping to achieve a rapid and unique process innovation, resulting e.g. in cost
decrease through productive capacity planning and stock management.
Platform of change strategy treats an ERP system implementation as a platform for introducing
stable, gradual changes in the system life cycle of an enterprise. This situation takes place in
companies that function very dynamically in the changing market. ERP systems in modern
“Life&Science” productive enterprises are expected to:
Ensure flexibility in the selection of informative – decisive user units in a dynamically changing
internal and external enterprise environment.
Possess various business process models, especially in the area: supply chain management,
warehouse management system, production management, advanced lot of row materials
management, advanced lot of products management, advanced lot of half-finished products
management, bar-codes management and quality management.
Provide the possibility to adjust systems in accordance with legal requirements and current good
practices in business.
Ensure system validation prospectively and retrospectively.
Ensure IT systems scalability in accordance with validation determinants.
A key condition concerning ERP class IT systems in the “Life&Science” branch productive enterprises
is obligatory validation. ERP system validation is process that leads to confirming a productive
system’s capability to complete process repeatedly and in accordance with defined criteria.
According to current legal requirements every “Life&Science” branch productive enterprise is obliged
to ensure validation productive machines, IT systems and laboratory devices that are critical to
production safety. The classical methodics for ERP systems implementation do not follow the
specificity of introducing systems that do not require obligatory validation. The life cycle of ERP
systems implementation in the “Life&Science” is different to other branches. Selecting appropriate
methodics of an ERP system implementation and completing a project according to it has an
influence on the quality of implementation, which is manifested in the following issues:
Gaining a temporary competitive advantage by an enterprise which has adapted an ERP system
as an effect of combining an appropriate business strategy supported by a correctly implemented
ERP system.
Precise mapping of business strategy in the area of an implemented ERP system functionality.
The cost of an ERP system validation during its exploitation
The cost of implementation and the cost of application maintenance (TCO) during 3 to 5 years of
its exploitation.
The goal of this article is to present the methodics of implementing ERP systems in the
“Life&Science” branch productive enterprises based the Polish experiences, with stress on:
The influence of the validation process on ERP systems implementation.
The influence of validation requirements on the selection ERP systems and implementation
partners completing the project.
2. The validation of ERP systems
The validation of IT systems and industrial automation is a requirement included in Polish, European
and American legal regulations. According to a Ministry of Health Ordinance on the 3 December 2002
concerning Good Manufacturing Practice requirements validation is defined as an activity aimed at
ensuring in a documented way and in accordance with Good Manufacturing Practice principles that
procedures, processes, devices, materials, activities and systems actually lead to the designed
results. IT systems’ validation should concern only these systems and in the scope of their critical
importance, ensure that they comply with quality standards and consequently ensure health and
safety of commercial end customers. The validation process is not linked to an IT system’s status but
with its purpose and a system’s impact on the process of a finished product’s manufacture.
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