Pharmaceutical companies, biotech firms, medical device manufacturers, and other Life Sciences companies are facing significant challenges in Quality Management. While their markets expect consistent and global quality, in order to stay competitive, they must also speed up their processes.
At Tenthpin, we help companies in the Life Sciences industry shift their Quality Management from a simple compliance task to a strategic business tool. Your Quality Management System (QMS) can be intelligent, integrated, and scalable. Our collaboration with 16 of the top 20 Life Sciences companies enables us to pinpoint how to create a better path forward.
The changing role of quality in Life Sciences
Life Sciences companies are dealing with shifting compliance requirements, more frequent audits, and complex supply chain demands. In pharmaceuticals, for example, stricter batch release controls and regional regulatory differences challenge quality consistency. Medtech is another example: integrating device software and AI introduces new validation and post-market surveillance needs.
On top of the increasing regulatory demands, many organizations still struggle with broken processes and outdated systems. This results in a gap between what Life Sciences companies need and what current Quality Management Systems can provide.
This scenario is behind a powerful transformation where quality is no longer just a back-office task. It has become a strategic necessity, and Tenthpin is leading the way in this revolution.
What’s missing in today’s Quality Management Systems?
Through our work, we have found two main types of gaps in QMS: functional and technological.
- Functional gaps: Many systems still lack well-developed certificate handling, audit preparation, supplier quality management, and real-time risk assessment. Disconnected workflows between manufacturing, supply chain, and quality limit traceability and responsiveness.
- Technology gaps: While AI and intelligent automation are progressing, their use in GxP environments is still hampered by validation issues, especially in Quality Management. Interoperability is uncommon; many platforms do not provide a complete, organization-wide view of quality.
The results of these gaps in today's quality systems are serious. They lead to slower decision-making, higher compliance risk, and less flexibility. Tenthpin's solutions are designed to tackle these challenges.
“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.”
Sabrina Graf, COO of Tenthpin, in an interview for European Biotechnology Magazine (2025)
Are LIMS still effective?
When talking about software for Life Sciences, like laboratory information management software (LIMS), it's important to remember that no single solution works for all clients. There are various options designed to meet different needs across the value chain:
LIMS
LIMS play a prominent role for companies with heavy lab-based testing and sample management requirements.
While LIMS solutions excel at managing test data and ensuring traceability at the sample level, they are not designed to handle broader quality system functions. Supplier management and complaint handling are easily overlooked by LIMS software. On the other hand, LIMS require huge integrations with other systems, like ERP, resulting in significant hidden costs.
Custom-built tools and workflows
Tailored software has become a useful solution for many Life Sciences companies, particularly those with unique business processes or old limitations. These solutions are built in-house or developed with software partners to fill specific gaps that standard platforms cannot address.
Despite their initial advantages, custom solutions tend to become challenging to maintain and update as your business grows or new technology trends appear.
ERP-integrated QM modules
This streamlined alternative embeds quality processes within the same ecosystem as finance, procurement, and supply chain operations. The modules facilitate data flow and cut down on repeated work.
However, ERP-integrated QM modules might not offer the depth and flexibility needed for more complex quality workflows.
QM solutions
Enterprise QMS remain popular due to their configurability and scalability. QMS solutions offer various capabilities, from document control and training management to deviation tracking and CAPA workflows.
Complexity, which may impact heavily-regulated industries, can sometimes be the trade-off for this customization.
How modern Life Science leaders are approaching quality
Top Life Sciences companies are investing in global standardization of quality platforms to improve data reliability, reduce redundancies, and enhance governance.
This journey is not a solo effort. It involves collaboration from strategic partnerships among industry players, technology vendors, and consultants like Tenthpin to speed up progress.
These collaborations produce ready-to-validate industry templates, reducing implementation times and ensuring regulation compliance. They also integrate quality into strategic planning, making it a key factor for long-term value.
You can still benefit from these insights even if your company is not among the top global leaders. Pre-validated solutions and widely accepted frameworks prevent you from starting from scratch and accelerate your path toward achieving market value.
Which Quality Management Solution is the right one?
Many organizations use standard Quality Management Systems built with SAP Clean Core principles to address the issues of fragmented or overly customized solutions. This method offers lasting scalability, faster upgrades, simpler compliance, and a strong basis for innovation.
At Tenthpin, we support this transformation with Tenthpin’s Intelligent Quality Suite, a portfolio of pre-validated, GxP-ready solutions that address the functional and technological issues listed above. Our modular components aim to improve visibility, simplify collaboration, and integrate quality into every step of your value chain:
Whether you're modernizing existing systems or building a future-ready quality landscape, we can provide your business with the tools and expertise to turn quality into a true value-driving factor.
Quality 5.0: from compliance to competitive advantage
Quality 5.0 seems to be the way for Life Sciences companies to gain a competitive advantage.
The approach of Quality 5.0 integrates advanced technology (AI, IoT, Big Data) with human‑centric values such as sustainability, employee empowerment, and system-level thinking. Life Sciences organizations can now combine AI-driven real-time monitoring and predictive capabilities with human expertise in decision-making. This strategy boosts efficiency, reduces waste, and improves product reliability.
The development of Quality Management is leaning towards intelligent, digital solutions that encompass the entire organization. At Tenthpin, we are working alongside industry leaders to advance this transformation. Our solutions, including the Tenthpin Intelligent Quality Suite and innovations like the SAP Batch Release Hub (BRH), are contributing to closing the most critical gaps at some of the world's largest Life Sciences companies.
