The Challenge

As one of the world’s leading specialists in immunology and hematology, Biotest AG, a listed biotech company headquartered in Dreieich, Germany, uses SAP QM to document lab data. Particularly important for the company in this regard is its use of the integrated SAP stability module for monitoring and documenting investigations into the stability of active ingredients. In practice, it has not always been possible to fully leverage the advantages of this module due to the lack of an affordable alternative to labor-intensive manual compilation of regulatory CMC reports. However, to streamline work processes, reduce time spent, and minimize data transfer risk, it is essential to implement an end-to-end reporting solution.

The Solution

Against this backdrop, up to data’s StudyReporter Stability software turned out to be just the right solution – an out-of-the-box tool that generates a nearly complete gamut of eCTD-conformant, regulatory stability reports and is also easy to configure, without labor-intensive coding. Thanks to StudyReporter Stability’s various modules for graphics, statistics, and protected tables, specific requirements such as CoAs, trending reports, and even complete product quality reviews can be elaborated in a manner that enables fully automated, valid data import from SAP QM or any other LIMS. Hence, for Biotest, StudyReporter Stability is an invaluable tool that reduces approval time and gives the company a competitive edge.

Advantages

• Efficient stability-report elaboration
• Configurable report templates (CoA, trending reports, PQR/APR)
• Quicker and simpler reporting process
• Intuitive – and thus extremely user-friendly – software
• Automated rather than manual data transfers, thus minimizing the risk of transfer errors
• Valid interface with SAP QM
• Short implementation time

An Optimal SAP-based Process for Efficient Stability Reporting

The gold standard for compliance with and monitoring of regulatory standards is IT-supported quality management. This applies in particular to highly sensitive blood plasma preparations by companies such as Biotest, for which quality is a key parameter for successful manufacturing in the context of international competition. But because implementing new software in this sector is typically both cost- and labor-intensive, it is all the more important to leverage the full potential of an IT solution to optimize the relevant processes while ensuring their reliability.

To this end, Biotest decided to extend its successfully rolled-out SAP system by implementing StudyReporter Stability – a solution the company selected for more reasons than meet the eye. StudyReporter Stability enables automated preparation of regulatory stability reports out of the box, thus obviating the need for an often time-consuming process involving application customization or additional programming. StudyReporter Stability is far more versatile than conventional reporting tools, is easy to configure, automatically extracts all necessary data from the SAP QM system, and compiles reports according to the relevant regulatory rules via a smooth-running overarching process and end-to-end stability-data management. StudyReporter Stability also integrates, as standard features, tools that support indispensable tasks such as data processing and statistical assessments.

Regulatory SAP Stability Reports

Implementation and customization of StudyReporter Stability, carried out in close cooperation with Biotest, proceeded very quickly, and the BAPI (business application programming interface) to the SAP system was customized following the completion of a feasibility study. In the interest of presenting the customer early on with an optimally tailor-made solution as a basis for development, up to data opted for an iterative project methodology that enabled the company to supply the customer with the relevant standard reports within the initial iteration test. Following the completion of a configuration analysis (including the definition of possible deviations from the desired report format), the interface and report templates were customized in accordance with Biotest’s specifications in the next iteration.

The validation process went equally smoothly, thanks in large measure to StudyReporter’s included vendor qualification, which enables the customer to incorporate the relevant documentation from up to data and validate the solution in accordance with GAMP 5 guidelines with minimal effort. Having opted for this procedure, all Biotest needed to do was document the attendant business cycle tests, which in turn saved the company a huge amount of time and effort compared to a complete validation.

This proved, for Biotest IT consulting manager Matthias Schott, that the company had definitely opted for the right solution: “StudyReporter Stability is easy to configure and roll out, and thus relatively inexpensive – which means that opting for an out-of-the-box solution such as StudyReporter Stability was the right decision. This is particularly evident all the way down the line when you compare StudyReporter Stability with the labor-intensive process of a customized solution.”

Conclusion

The main benefit Biotest derives from StudyReporter Stability is that the solution meets all requirements for rapid off-the-shelf implementation. When rolled out using up to data’s iterative project methodology, StudyReporter Stability allows for streamlined workflows and high-quality project realization.

Particularly noteworthy is the ease with which StudyReporter Stability can be adapted to specific business processes, and the fact that it obviates the need for the customizations and time-consuming validation required by individual SAP-based applications. In a production environment, StudyReporter Stability’s end-to-end processes and reliable data transfers are extremely impressive. Thanks to up to data’s extensive and detailed knowledge of current regulatory requirements and versatile LIM-Systems, StudyReporter Stability delivers an impressive set of functionalities off-the-shelf.

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StudyReporter Stability was previously known as iStudyReporter Stability. As part of a redesign and rebranding, the reporting solution is now part of the StudyGen 360 lab data platform and covers the report-generation portion of the application family, known as StudyGen Reporter Stability, or StudyReporter for short.