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Strategic Planning for ELN Systems to support QC and AR&D Regulated Laboratories

Situation

PharmaceuticalIn support of their compliance and lean operation initiatives, a Global leader in generic pharmaceuticals contracted CSols, Inc. to perform a strategic assessment for selecting an Electronic Laboratory Notebook that would be implemented for multiple sites and divisions. Additionally, CSols was tasked with determining the best strategy for selection and implementation as the system would need to interact with existing systems such as SAP QM, LIMS, and various CDS that were implemented with limited functionality and for limited business processes. Decisions such as: where information should reside, what enhancements in LIMS would be required, and what approach should be taken for the implementation needed to be determined.

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