Case study: Zhongxi Sunve automates and enhances pharmaceutical quality management

In 2016 Zhongxi Sunve recognised the need to invest in digital

systems for its laboratories to support its ‘smart medicine’ initiative which incorporates digitalisation, networking, sustainability and environmental considerations. Historically, Zhongxi Sunve still relied on too many manual, paper-based processes including manually-transcribed testing data, paper-based data storage and transmission, as well as manual task assignment and progress tracking. In addition to introducing the risk of transcription errors, it also made it difficult to search and process data quickly. All this made it very difficult for laboratory managers to do their jobs effectively. Zhongxi Sunve decided to

purchase a LIMS for several reasons, with the most important being the ability to track and trace data quickly to make its laboratories more compliant. The company also wanted to quantitatively assess all laboratory resources through a digital system to achieve effective resource management. Finally, Zhongxi Sunve needed to access and statistically analyse QC data in real-time to enable scientific management of the data, and to achieve a paperless laboratory. The decision- makers at Zhongxi Sunve selected Thermo Scientific SampleManager suite because of its integrated LIMS, SDMS, LES and ELN capabilities.

Delivering a successful informatics implementation SampleManager LIMS software was deployed centrally across Zhongxi Sunve using virtual platform | @scwmagazine

technologies. The system covers the management of the entire production sample process, including registration, collection, reception, distribution, analysis, result, entry/review and reports preparation/review/sign-off. SampleManager

LIMS software was also fully integrated with the Manufacturing Execution System (MES), and managed stability inspection, environmental monitoring, personnel, instrumentation, methods, standards, reagent inventory, system security, data query and analysis.

The LIMS was implemented

in two phases. Phase one focused on developing sample life cycle management and all elements of laboratory management. Phase two will cover electronic SOPs and instrument connectivity. Before phase one of the implementation, the service team at Thermo Fisher Scientific worked with Zhongxi Sunve to understand its business and laboratory processes, such as sample testing, supplies/reagents, instruments management and specific coding rules. The team worked closely with Zhongxi Sunve’s project execution team, as well as ongoing software and hardware support resources, including system and IT administrators. To start the implementation, Thermo Fisher’s service team held several meetings with quality directors, QC managers and QC laboratory analysts at Zhongxi Sunve’s Xinghuo and Waigang facilities to confirm project plans, arrange training and analyse and verify requirements. This was followed by system

configuration and design, ‘double-track’ operation, and UAT confirmation and validation programs. During a trial period, more than 150 users processed almost 7,000 reagents and reference materials, as well as more than 4,000 batches of finished products, raw/auxiliary materials, and intermediates, along with purified water and samples of sedimentary and planktonic bacteria in environmental monitoring.

‘As Zhongxi Sunve grows, SampleManager’s flexible workflow will adapt to new applications’

Following this successful trial, Zhongxi Sunve went live with SampleManager LIMS software. Thermo Fisher Scientific’s

reputation as a trusted informatics partner and support provider gave Zhongxi Sunve the confidence to move forward. As Zhongxi Sunve grows, SampleManager LIMS software’s flexible workflow will adapt to new business applications, such as new product lines and enable onboarding of new methods, testing standards, workflows, personnel, instruments and devices.

Integration into Zhongxi Sunve’s Informatics Ecosystem Zhongxi Sunve has begun integration of the LIMS with their production and laboratory infrastructure. True sample life cycle management was achieved by integrating the LIMS with the MES at its production facilities. In Phase two of the implementation, further systems will be integrated with LIMS including ERP, Thermo Scientific Chromeleon Chromatography Data System (CDS) software, the training system and the CAPA system. The company will also implement the Laboratory Execution System (LES) and instrument data collection capability within SampleManager LIMS software. Thermo Fisher will continue to provide technical support and services for system application and daily optimisation, security and computer-based system validation. By incorporating the LES, instrument data collection and Chromeleon CDS software, Zhongxi Sunve will achieve further paperless laboratory management and automation, lower management costs and ensure continuous improvement and mitigate compliance risks to bring its quality management process to a new level.

Winter 2021 Scientific Computing World 23

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