Case study: Harmonising systems and data management

FAIR data processes, harmonising and interconnecting systems drive digital transformation in the pharmaceutical laboratory

To standardise processes and to ensure FAIR (Findable,

Accessible, Interoperable and Retrievable) data, a global pharmaceutical company looked to harmonise and integrate existing tools, systems and technologies across their chemical and pharmaceutical development (CPD) organisation. The department is responsible for the development, manufacture and supply of new active ingredients, from late research throughout all phases of product development until launch. They also supply investigational products for phase I to phase IV clinical trials and manage the development and characterisation of pharmaceutical formulations. The CPD department was using six disconnected systems and more than 1,000 disconnected instruments. There were large differences between sites and departments, with heterogeneous IT landscapes and inconsistent LIMS usage, meaning the project required significant conceptualisation to create a strategy incorporating every system. The goal was not to replace hardware and systems, but to drive integration across existing instrument and software, enabling the department to leverage its current investments.

Building a connected scientific ecosystem Thermo Scientific SampleManager LIMS, LES

30 Scientific Computing World Summer 2021

and SDMS was chosen to manage laboratory, data and procedural workflows. Thermo Fisher’s integration technology was then used to enable cross-connectivity between SampleManager software and the incumbent CDS and ELN and across to SAP, as well as the instruments and equipment used in the lab. At the start of the implementation, the teams analysed the existing known pain points and, through a third party, performed a multi- moment analysis to identify any unknown bottlenecks in the process. The team then took a pragmatic approach to identify the best practices for the new solution. The team architected a workflow that connected all of the major systems in their process. An important element of the

project was also to improve the human experience. Scientists were spending a disproportionate amount of their time on time-intensive, low-value work, like manually moving data between systems. The organisation recognised the importance in eliminating these tasks, not just for productivity, but to ensure they were able to attract and retain top scientific talent. Before the implementation, each analytical development, formulation development and quality assurance site was disconnected from its peers. After the implementation, the CPD department functioned as one connected global team. The scope of the

implementation covered all of the major workflows, including: • End-to-end sample management, from preparation to certification

• Management of stability studies and testing, such as content uniformity and dissolution

• Control of reagents and assets, including columns

• Integration of instruments and instrument logbooks

• Development of drug product formulations

Paper-based processes were drastically reduced. Documents like order, sample preparation and raw data sheets all became part of a fully digital process. Today, the organisation has a fully connected workflow between LIMS, ERP, ELN, CDS and more than 1,000 complex and simple instruments. The higher degree of integration achieved has increased efficiency by 20 percent, with additional improvements to both data quality and integrity. Eliminating manual transfer of data reduced the risk of transcription errors, while the laboratories benefit from the security of a full audit trail, including a risk-based audit system. Information isn’t simply

captured as ‘paper on glass’, but intelligently linked to improve searchability. This project also highlights the importance of cultural change to a successful data strategy. The real measure of success for any system

“Scientists were spending a disproportionate amount of their time on time-intensive, low-value work, like manually moving data between systems”

deployment is that of the end users. When asked about the implementation, users highlighted the improved access to data, logical workflows, enhanced data management and traceability, as well as system flexibility. By improving on the systems they already knew through tighter connectivity, the team was able to generate significant benefit to the users without introducing unnecessary change.

Scientists are often required

to focus on operational tasks, detracting from their real strength. By establishing a holistic strategy that incorporates the people who use the systems, pharmaceutical manufacturers can ensure their data integration programs are more effective. Despite the different modules and capabilities, the user experience across the laboratories is nearly seamless – and scientists now have more time for what they are most passionate about: science.

Strategic partnership was the formula for success The success of the project was driven by the strategic partnership and common goals between the pharmaceutical company and the implementation team. Between the clear direction and vision of the laboratory and IT team and Thermo Fisher’s system and integration expertise, the team was able to make the lab of the future a reality. This project had a

transformative impact on the business. Today, their integrated infrastructure benefits not only the laboratory, but all aspects of their operations. The LIMS facilitates compliance with regulatory processes and enables significant improvements in product quality. The system provides a seamless flow of information throughout the development, scale-up and manufacturing process.

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