The tenth pin for quality management in life sciences

EuroBiotech_What are currently the most important challenges for globally active drug developers and how can AI and automation contribute to a productive solution?
Graf_Life sciences companies, as well as service providers for clinical trials and biomanufacturing, are facing a major transformation. The steadily increasing price pressure from the healthcare system, everhigher regulatory requirements for documenting the development process, more complex therapeutic modalities, the decentralised manufacturing of increasingly personalised therapies, and the coordination of biomarker and therapy development and global roll-outs require a growing reduction in errors and greater productivity from developers. The increasing use of AI tools promises not only a reduction in development times but also higher profits due to a lower error rate and better compliance rates in the highly regulated field of drug development, optimal utilisation of global supply chains, and the product development process. Corresponding AI applications are already being used for the automated recruitment of suitable participants for clinical trials and their design, the identification and validation of biomarkers that facilitate the right therapy choice, remote patient monitoring, and the automated GxP-compliant process optimisation and quality documentation. Many companies are still in the process of separating the AI signal from the noise. They are looking for reliable AI applications that offer fast implementation times, high returns, and immediate availability. Tenthpin’s expertise in life sciences, SAP software, and AI in-house developments helps to find the right and reliable application for a customer’s problem.

EuroBiotech_Where does Tenthpin see the digital journey going for life sciences companies?
Graf_The digital journey is accelerating rapidly, driven by AI to make processes faster, more accessible and more personalised. Our clients want to procure standard software built and operated GxP compliantly and industry standards that make it easier for them to simplify their system landscape. Particularly, SAP customers are striving towards keeping their Core clean with minimal bespoke custom coding and enriching functionality by procuring standard solutions for instance in the quality management space. It is an approach to having a system that is flexible, extendable and easy to upgrade.

EuroBiotech_Can you please give us a brief portrait of Tenthpin’s goals and the resulting core business, as well as the response from the life sciences sector – from finding the company name, founding the company in 2017, until today?
Graf_Let’s start with the name as it reflects our ambition for the market: 1841 Connecticut law banned ninepin bowling as it was deemed to promote gambling. Adding an extra pin (the famous Tenthpin) gave people a way to keep bowling. The tenth pin made the difference and paved the way for the success of the game. Some sources call this story a mere fable, while others confirm it. Today bowling is played by 120 million people in 90 countries. Our goal is to be the leading partner in life sciences for intelligence transformations to advance modern medicine – being the tenth pin for our clients. Being fully focused on one industry sector, the life sciences, we combine business process and technology know how to deliver true business value utilising state-of-the-art technology. We combine consulting as a partner for SAP-enabled business transformations in the life sciences industry with solution and software development. For our clients, we act as a partner for co-innovating new products that address significant industry gaps by leveraging state-of-the-art technology. Today, we are working for 16 out of the 20 largest life sciences players while many mid-size players like CDMOs rely on our services and products. We realise superior standard software solutions to create business value by leveraging latest technologies.

EuroBiotech_What consulting, software and AI services does Tenthpin offer to enable shorter time-to-market, compliance and profitability?
Graf_With our clear industry focus on the life sciences and our standard process models, specifically for biotech, pharma, medtech, diagnostics companies, CROs, and CDMOs, we make ERP transformations more efficient in terms of lead times, costs, business value created and keeping the core clean. We recognise that the life sciences industry sector is undergoing a rapid transformation into a data-driven deeptech industry. Leveraging our roots in consulting, along with our expertise in SAP and other technologies, we have a global team of highly experienced industry experts, software engineers, developers, and UX specialists, committed to delivering software solutions and closing the gap of missing standard software. For example, Tenthpin collaborated with SAP to develop new SAP standard software products such as the SAP Batch Release Hub, SAP Intelligent Clinical Supply Management, and SAP Cell & Gene Therapy Orchestration. Together with our clients and partners like AWS we identify industry gaps and develop software solutions that address fundamental shortcomings or efficiency needs supporting the ambition of generating industry standards. We know how to combine agile approaches and compliance requirements like GxP and HIPAA with state-of-the-art technologies including AI and cloud platforms to create superior solutions.

EuroBiotech_What gap does Tenthpin close with its software compared to industry-standard QM functions in ERP systems?
Graf_Overall, we minimise compliance risk, cost and increase overall supply chain efficiency. With Tenthpin’s Intelligent Quality Suite we developed a portfolio of standard software called T/ICV, T/ICG, T/QME to support quality processes and industry- wide collaboration.

T/ICV (Tenthpin Intelligent Certificate VerificAItion): Tenthpin has developed a solution that uses AI and Large Language Models to extract all data from CoAs (Certificate of Analyis), CoCs (Certificate of Conformity), and CoSs (Certificate of Sterilisation) to automate the certificate comparison against corresponding specifications, and to handle the end-to-end approval process. The business case for this AI driven solution is overwhelming, as it reduces the time spent on manual checks by 90%, while ensuring unmatched accuracy.

T/ICG is a flexible certificate generation solution to cover various regulatory industry requirements towards batch certificates (e.g. EU GMP Annex 16), which significantly reduces manual interaction times, at the same time increasing the quality.

T/QME (Tenthpin Quality Management Evolved) enriches existing SAP S/4HANA processes in the QM domain. It is qualified to be GxP-ready and fully embedded into the production and supply chain processes. T/QME enables the effective execution of quality control and quality assurance activities through automating back-end processes – from sample creation to batch release – with an enhanced and modern user interface.

EuroBiotech_Could you please give some examples/use cases of how Tenthpin has helped clients to automate and digitalise their processes?
Graf_For a globally acting CDMO, we accomplished a major SAP enabled business transformation based on S/4HANA. Given the client’s highly complex system and process landscape and reliance on manual processes for compliance, our goal was to pilot the implementation of SAP S/4HANA (RISE/PCE) across four manufacturing sites and the holding company. We integrated multiple systems (LIMS, SuccessFactors, DMS, etc.) and ensured that templates met the requirements of all sites. Leveraging our ready-to-use CDMO process template, we significantly enhanced process efficiency, provided full transparency on customer project margins, and successfully completed the pilot SAP S/4HANA (RISE/PCE) implementation within 15 months. Additionally, we ensured GxP-compliant processes and implemented our Tenthpin Quality Management Evolved (T/QME) as a standard software solution, achieving a rollout in just two weeks.
With one of the biggest global Pharma companies, we digitise the whole verification process for certificates of sterilisation (CoS). All incoming CoS are verified with our AI-powered Solution (T/ICV) that helps our client to reduce the time per certificate verification from 30 minutes to less than five minutes for more than 60.000 certificates per year. In a next step the same standardised platform, T/ICV, will be leveraged to streamline the verification process for Certificates of Analysis (CoA) and Certificates of Conformity (CoC), further enhancing efficiency and automation. 

Dr Sabrina Graf is the Chief Operating Officer of Tenthpin Management Consulting and Solutions – a globally leading business and technology
consultancy for the life sciences industry. With more than 15 years of leadership experience in consulting and finance, her career has focused on navigating complex organizational transformations.

This interview was originally published in European Biotechnology Magazine Spring 2025.