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Deployment & Validation of Thermo SampleManager™ LIMS

Situation

PharmaceuticalA Fortune 500 pharmaceutical company was conducting a global Implementation and Validation across 6 countries and 19 sites. The CSols team was selected to assist with the SampleManager™ LIMS project by performing multiple roles over a two-year period. The solution had to be 21CFR Part 11 compliant and for the validation to be based on the GAMP 4 model. The implementation included new interfaces, and improved upon existing SAP and Chromatography interfaces. The solution facilitated Controlled Worksheets, provided multi-language Certificates of Analyses, and produced Annual Product Reviews.

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