巴西GPSG的Thermo Scientific CONNECTS提供企业级生产力，将实验室连接到ERP

全球药品供应集团(GPSG)巴西是Janssen-Cilag Farmacêutica有限公司的APILA部门。(www.janssen-cilag.com。br)位于São圣保罗，巴西。Janssen-Cilag是全球领先的研究型制药公司之一，专注于疼痛管理和真菌疾病，同时也是全球最大的个人护理和健康产品制造商强生家族的成员。GPSG巴西采用了全面的企业集成解决方案来简化业务流程。采用热科学GPSG的CONNECTS包括实验室仪器和信息软件，企业系统和文件管理工具，以提供一个完全集成的制药生产环境。Thermo Scientific LIMS和Atlas CDS的标准化使GPSG能够专注于巴西工厂的产品质量。GPSG巴西的制造工厂位于São José dos Campos, São Paulo，每个月都要处理超过10,000次分析，以确保近2,000个原材料、包装材料、半成品和成品样品的质量。该基地配备齐全的实验室加上微生物，化学，分析开发和研发实验室。GPSG巴西等制药公司被要求根据美国FDA的具体指导方针控制其分析的质量，这些指导方针适用于在其实验室中创建、修改、维护、存档、检索或传输的电子格式记录。这些规定甚至适用于未在提交中使用的记录，如培训记录和标准操作规程。因此，GPSG巴西面临的主要挑战之一是需要使用经过验证的CDS和LIMS系统，以确保符合在这种高度监管的环境中执行的标准和程序。对于GPSG巴西来说，在整个企业的LIMS、CDS、ERP(企业资源规划)和文档系统之间集成数据的一致策略是一个关键的业务驱动因素。GPSG巴西选择Thermo Scientific LIMS部署在其实验室中，以确保与企业资源规划包SAP R/3集成。在生产工厂和分析生产数据的实验室之间，需要定期交换关于质量和分析值的信息。 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.