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Information and Knowledge Management using ArcGIS ModelBuilder

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Bartosz Wachnik<br />

Guaranteeing a knowledge transfer from consultants to key users both formally, through trainings<br />

<strong>and</strong> h<strong>and</strong>books, <strong>and</strong> informally, during tests, data migration, as well as parametering. Possessing<br />

knowledge about the system by the key users is one of the key factors for an appropriate ERP<br />

system validation.<br />

Guaranteeing a completion of suitable documentation on each implementation stage, if required<br />

by the validation.<br />

Guaranteeing a completion of multileveled tests, i.e. preliminary tests, in-depth tests of selected<br />

functionalities <strong>and</strong> acceptance tests. The methodics should guarantee a suitable documentation<br />

required by the validation within the range of tests completion as well as the regulation of an ERP<br />

system that is being implemented.<br />

The Life&Science branch, especially pharmaceutical companies, is treated as rich compared to other<br />

branches. Implementing management support systems, among others ERP, for this type of<br />

enterprises is more expensive. The reason is the higher labour intensity, resulting mostly from the<br />

questions of validation. Nevertheless, there are cases of implementation where the implementation<br />

budget exceeds the original budget by 100-200% <strong>and</strong> the implementation does not accomplish its<br />

organizational <strong>and</strong> economic goal, e.g. after the validation a system is not recommended for use <strong>and</strong><br />

requires regulation (tunning). Appropriate implementation methodics designed for a given<br />

“Life&Science” branch enterprise may significantly decrease the probability of organizational<br />

turbulence <strong>and</strong> an increase of implementation cost.<br />

References<br />

D. Remenyi, A. Money, M. Sherwood-Smith (2000), The Effective Measurement <strong>and</strong> <strong>Management</strong> of IT Cost <strong>and</strong><br />

Benefits, Butterworth-Heinemann, Oxford.<br />

M. Parker, J. Benson (1988), <strong>Information</strong> Economics, Prentice Hall, Upper Saddle River.<br />

Hojdyś K.(2004), Applying the GAMP 4.0 methodics in implementation of IT system validation. Process<br />

optimization on the basis of risk analysis. Oinpharma Ltd. (formerly Polfa Centre for Scientific <strong>Information</strong>),<br />

Warsaw.<br />

International Society for Pharmaceutical Engineering. Good Automated Manufacturing Practice Guide for<br />

Validation of Automated Systems, www.ispe.org<br />

General Principles of Software Validation; (January 2002) Final Guidance for Industry <strong>and</strong> FDA Staff U.S<br />

Department of Health <strong>and</strong> Human Service Food <strong>and</strong> Drug Administration, Washington.<br />

Rodriguez J., Validation of an Enterprise Resource Planning (ERP) System: An SAP Case Study. Journal of<br />

Validation Technology May 2003, Volume 9.<br />

500

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