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Strategic Planning: Paperless Lab Solution Functional Architecture Critique

Situation

PharmaceuticalA global leader in the development and manufacturing of branded and generic pharmaceuticals has initiated a paperless laboratory project in support of its operational and compliance needs. In pursuit of this endeavor, the client retained the strategic planning services of CSols, Inc. to perform a functional architecture assessment of its proposed paperless solutions. This paperless lab solution involves both new and existing applications – ELN, LIMS, SAP QM, SDMS, and instrument integration. CSols was tasked with examining the proposed functional architecture and determining its technical feasibility. As such, CSols was responsible for identifying any project risks and gaps, as well as to provide options for risk mitigation and key recommendations for deployment.

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