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Business Challenge
Pharmaceutical manufacturing companies such as GPSG Brazil are required to control the quality of their analyses according to specific US FDA guidelines, which apply to electronic format records that are created, modified, maintained, archived, retrieved or transmitted in their laboratories. These regulations are valid even for records that are not used in a submission, such as training records and SOPs. As a consequence, one of the major challenges facing GPSG Brazil was the need to use validated CDS and LIMS systems that enable compliance with standards and procedures enforced in this highly regulated environment. For GPSG Brazil, a coherent strategy that integrated data between the LIMS, CDS, ERP (enterprise resource planning), and Documentation system across the enterprise was a key business driver.

GPSG Brazil wanted to deploy state-of-the-art technology which delivered significant flexibility to meet the specific needs of the pharmaceutical industry, such as stability, supplier certification and microbiological analysis. The company has been using the Thermo Scientific LIMS solution since 1999 to store and control laboratory quality data and the Thermo Scientific CDS solution since 2001 to collect, process and ensure safety of the chromatographic data generated within its laboratories.