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Thermo Scientific CONNECTS at GPSG Brazil Delivers Enterprise-Level Productivity Linking Laboratories to ERP


The Global Pharmaceutical Supply Group (GPSG) Brazil is an APILA unit of Janssen-Cilag Farmacêutica Ltda., (www.janssen-cilag.com. br) located in São Paulo, Brazil. Janssen-Cilag is one of the world’s leading research-based pharmaceutical companies specialising in pain management and fungal disease, and a member of the Johnson & Johnson family of companies, the world’s largest personal care and health products manufacturer. GPSG Brazil has adopted a comprehensive enterprise integration solution to streamline business processes. The adoption of Thermo Scientific CONNECTS at GPSG consists of laboratory instrumentation and informatics software, enterprise systems and document management tools to provide a fully integrated pharmaceutical manufacturing environment. Standardisation on Thermo Scientific LIMS and Atlas CDS has allowed GPSG to focus on product quality in its Brazil facility. Every month, GPSG Brazil’s manufacturing plant in São José dos Campos, São Paulo, processes more than 10,000 analyses to ensure the quality of nearly 2,000 samples of raw materials, packaging materials, semi-finished and finished products. The site is fully equipped with an incoming laboratory plus microbiological, chemical, analytical development and research and development laboratories. 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 selected Thermo Scientific LIMS to deploy in its laboratories to ensure integration with corporate enterprise resource planning package, SAP R/3. Between the production plant and the laboratory that analyses data from production, there is a need for regular exchange of information about quality and analysis values. By interfacing the LIMS with its ERP, GPSG Brazil can expedite the data flow between the lab and the manufacturing functions, streamline data handling, and integrate data collection and reports. Ronaldo Galvao, Quality Operations Director – GPSG Brazil clarified, “At the time we selected Thermo Fisher as our vendor of choice, we made the decision to standardise on a company with proven expertise in the pharmaceutical industry. We needed a validated product that provides us with sufficient flexibility to deliver all the requirements that a pharmaceutical plant has such as data security and consistent quality data; a centralised repository for the Quality Management data; fast and accurate data storage and recovery and all the industry functionality.”


Post-implementation


Benefits Seamless integration of laboratory instruments to the LIMS and the LIMS to the existing ERP system at GPSG Brazil ensures full regulatory compliance; for example, with the US FDA 21 CFR Part 11 standard that covers storage and integrity of computer systems data. Controlled and traceable versions of the original data are created and the whole history of any modification carried out is securely stored, thus ensuring complete system validation. The CDS/ LIMS integration also supports and enables the periodical auditing of the supplier certification system utilised by the company to guarantee the quality of its raw materials. Ronaldo Galvao explained, “The LIMS/CDS solution achieves quick and accurate transfer of high volumes of data, increasing sample throughput and improving laboratory productivity.” The integration of LIMS, CDS and ERP at GPSG Brazil has enabled their researchers to view information that was previously only available in data reports. “The overall integration of our connected informatics solutions provides a seamless and secure quality environment at GPSG Brazil,” concludes Galvao.


Circle no. 130 ILM_Connects.indd 1


It’s about integration.


Which is why it’s about time you invested in a Thermo Scientifi c Laboratory Information Management System (LIMS). The most successful businesses are those that utilize technology to bring the full scope of the lab into the business – by integrating people, data systems and instruments. We build the integration capabilities you need into the core of every Thermo Scientifi c LIMS so you can make faster and better informed business decisions, decrease your time to market and improve your margins.


Now with Thermo Scientifi c WebAccess Suite, all you need is ™


a web browser for full, secure, high performance access to any Thermo Scientifi c informatics solution – from anywhere. Web deployment of any Thermo Scientifi c LIMS. That’s all about integration. Isn’t it about time? Your time.


Call +44 161 942 3000 (Intl) or +1 866 463 6522 (US) marketing.informatics@thermofi sher.com


Thermo Scientific CONNECTS - Integrating instruments, informatics software and enterprise systems for faster, more informed decisions. To learn how CONNECTS can help bridge the gap between lab data and enterprise knowledge, visit www.thermo.com/connects


Moving science forward


Circle no. 131 1/19/10 12:30 PM INTERNATIONAL LABMATE - APRIL/MAY 2010 - ADVERTORIAL


© 2010 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries.


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