Tailoring a CMS validation implementation to your organization’s compliance agenda using intensity profiles

This white paper by Prime Technologies Inc. explains how to tailor a calibration management system validation implementation to an organization’s compliance agenda using intensity profiles. An intensity profile, when describing a CMS implementation or validation project, is a set of business characteristics and compliance needs that affects the cost, duration and complexity of the project. Three intensity profiles (high, medium and low) developed in this paper focus on parameters including validation, scope, requirements, resources, GAMP 4 Software categorization, environments, data migration, documentation and vendor assessment. By identifying itself within one of the three intensity profiles, an organization can gauge the effort required to successfully deploy its particular CMS.

Published:	2005
Format:	PDF
Length:	10 pages
Type:	White paper
Language:	English

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