Compliance challenges with enterprise application integration

Implementing an enterprise application to integrate multiple systems poses unique challenges to validation efforts. This white paper by Clarkston Consulting describes challenges faced by life sciences companies to meet 21 CFR Part 11 regulations with respect to enterprise application integration. The Food and Drug Administration requires data integrity and traceability for all good manufacturing practices information related to equipment and computer systems. With a well-defined approach to validation, a thorough analysis and understanding of the data and systems, and a software tool from a vendor with auditable development methods, integration in a regulated environment can become a very successful investment.

Published:	2004
Format:	PDF
Length:	10 pages
Type:	White paper
Language:	English

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