Background and ChallengesIn a highly regulated industry like pharmaceuticals, companies have to document and manage their production processes and according data continuously, as well as put them to use in order to optimize their own processes and products. This also applies to CSL Behring. The globally active company develops biotherapies from plasma – in eight production sites worldwide, with more than 25.000 employees. Concerning data management and analytics the past years included the following challenges:
- Implementation of a paperless collection, conversion and especially validation of data at various points within the production process.
- Better and faster analysis of data from different source systems: get the data to employees in a way that they always have the relevant information at the right time and place in order to generate additional value from it.
- Compliance with continuously growing regulatory requirements in the industry – concerning applications, analytical models and the respective data.
To optimize the data management within the company along the above-mentioned criteria, CSL Behring is continuously establishing a company-wide data warehouse, in order to simplify access to all data sources. Alongside, CLS Behring is using TIBCO® Statistica™ Enterprise (part of TIBCO® Data Science) as a universal data science platform since 2013. This development is driven by a close partnership with StatSoft, several validated applications and other analytical projects. Additionally, many existing analytical processes were replaced and automated within the platform. Among the collectively implemented projects so far there are automated reports related to validation and stability. These report processes were to some extent known for their high expenditure of time and error rate, due to the manual data collection. With the support of StatSoft in the deployment of new applications based on TIBCO® Statistica™ Enterprise , lean processes were developed.
Such as: automated import and processing of data, including automated audit trails and authorizations (electronic signature) as well as automated reporting, e.g. (encrypted) pdf documents. Thus, CSL Behring can comply with regulatory requirements, having fast and transparent processes. Due to the automation of data processes from analytics to reporting, thousands of work hours were freed. This capacity is now used for intensive analytical work which again generates additional value. A proper and important step towards digital process optimization. Concerning the IT, additional economizing was possible, because the IT department now manages one platform instead of various tools and large amounts of code. The combination of increased efficiency and cost reduction equals CSL’s investment multiple times.
The Formula for Success: StatSoft as a catalyst and supporter of a progressive data analytics team
For the development of analytical projects, StatSoft usually supports their clients as a sparring partner. This also applies to CSL Behring. With a proof of concept as starting point, some functionalities of the TIBCO® Data Science™- platform were put to use in practice. Over the past years, various data science applications were developed in additional projects. The core of the longtime cooperation is the iterative process between experts on both sides. Projects are developed through a dynamic exchange of ideas, triggered for example by questions, newly available data or new regulations. This agile approach, based on mutual trust, combined with the industry know-how of the client and the technical and analytical know-how of StatSoft experts leads to faster success than long specification sheets and classic waterfall methods.
Over the years, a symbiotic team developed – consisting of CSL specialists from the Data Analytics Center of Excellence (DACE) and a long-term-active StatSoft team of experts – that works according to the client’s individual circumstances, e.g. with a specific project method. The small team is able to implement comparably many projects in data analytics efficiently and thus generates additional value for many users. That is why the cooperation is highly valued within the organization of CSL Behring. Another crucial point of success are systematic and repetitive trainings on the use of the platform for CSL employees. With the help of a train-the-trainer-approach, more than 300 users on different levels are currently using various applications, only taking into account the CSL-site in Bern.
The platform: TIBCO® Statistica™ Enterprise
As a universal analytics platform TIBCO® Statistica™ Enterprise integrates into the digital structures at CSL Behring. Data from various independent sources are gathered in the data warehouse, completely paperless. From there they supply various analytical projects.
TIBCO® Statistica™ Enterprise simplifies these processes with its gateways to various systems and thereby establishes a basis for successful analytical work. At the same time, necessary authorization processes are integrated into the system. New data sources can easily be integrated into this infrastructure.
The platform’s functionalities enable two ways of gathering insights from the data without difficulty:
- Generate information based on particular data
- Prepare and analyze matching data to a certain user scenario
TIBCO® Statistica™ Enterprise enables the development of applications for different purposes and user groups, step by step and within one platform. This is not only (cost)efficient but enables also the increasing automation of data analytics. Missing functionalities can easily be added in the process. All this facilitates data management, for example concerning the management of different versions, documentation and validation of data. With its low code-approach the platform is attractive to broad user groups and the analytical results can be shown to various users more easily, e.g. through multiple options of visualization.
Several validated applications on the analytical platform originated from the close cooperation of the data experts at CSL and StatSoft. Including various automated reports like Monthly Trend Reports (MTR) or Annual Product Reviews (APR), Impurity Profile Reports, Continuous Process Verification Reports (CPV). What should be mentioned specifically is that Validation Protocols as well as Stability Studies and Trend Analyses or Release Reports are now completely digitized. This includes the validation, electronic review of the data up to the compilation of reports in an encrypted pdf format. There are additional applications: a comparison of process control parameters and quality attributes, including several production sites or the increase of the yield in production through the application of boosted regression tree algorithms.
CSL Behring most systematically pushes the use of data on the platform forward and uses the opportunities of TIBCO® Statistica™ Enterprise in the areas of validation and approval like no other StatSoft client. Overall, the optimization of its data management is the basis on which CSL Behring is able to meaningfully experiment with current hype topics such as Artificial Intelligence (AI) and Machine Learning.
The longterm personal collaboration is based on great mutual trust and open dialogue. The platform is developed in close exchange, according to the client’s specific needs. The client knows what they need and we support them with our know-how in the areas of technology, data processing and data science. With this close exchange and the iterative approach, we achieve their goals faster. We are practically the catalyst for the work of CSL. We lower the activation effort for the development of solutions based on the TIBCO® Statistica™ Enterprise-platform and with other commercial and open-source-tools.
Michael Busch, Lead Data Engineer, StatSoft
In order to implement the main goal – paperless processes – other systems would have worked equally well. But other tools do not necessarily offer data management and analytical capabilities too. TIBCO® Statistica™ Enterprise brings all this together.
Statistica gets us on the right track in our digital transformation. The close cooperation with and the support of StatSoft leads us to quick successes. When they have developed something, we are able to ask questions right away, learn from that and are later able to implement many things ourselves. This knowledge transfer is worth a lot and the saved work hours and generated additional values speak for themselves.
Janine Kuratli, Manager Data Analytics, CSL Behring
Continuous new projects
Together with StatSoft, new projects in the areas of data preparation, data analytics and reporting, which also includes a sustainable documentation, are developed continuously. The platform and its applications are supervised by a global team of CSL Behring with people working from the US, Australia and Europe since 2019. The onboarding of new administrators abroad is handled pragmatically through online trainings from StatSoft. This was a major precondition for the global rollout of applications.
Furthermore, work is done on the automation of additional solutions in order to make the platform and its applications efficiently usable for even more CSL employees and simplify processes further. Finally, the previous automation steps and their massive reduction of working time are the basis for CSL’s increasing engagement in more complex applications in the areas of Artificial Intelligence and Machine Learning.