Working in Life Sciences, you learn that every decision is a delicate balance between two forces: the rigorous demands of regulatory compliance and the constant push for technological innovation.
For leaders in Pharma, MedTech, and other Health-related companies, this often creates a profound tension. You know that modern, agile technology is essential for future growth, but the fear of disrupting validated quality processes feels like a dangerous risk.
What if you don’t have to choose between the two?
The journey to modernizing an enterprise often hits a roadblock at Quality Management Solutions. Many organizations have long relied on custom-built systems to handle their unique quality workflows, and for a time, these systems seemed to meet customer and industry standards.
However, as businesses expand, these tailored solutions begin to expose underlying challenges, such as increased technical debt. Custom-built systems create a labyrinth of code that becomes difficult to control and costly to upgrade. They represent a significant barrier to adhering to a Clean Core strategy.
Moreover, achieving compliance with international standards like ISO 9001 can become complex when customized systems are involved, because custom-built software can hinder performance and efficiency.
The core conflict is rooted in validation. When a Quality Management Solution is deeply customized within the SAP core, any system upgrade or security patch can trigger an extensive and resource-intensive re-validation of the entire system. This process consumes valuable time and resources, creating the bottlenecks that the Clean Core strategy is meant to avoid.
A GxP-ready solution that embraces internationally recognized standards (such as ISO 9001) is the key to this challenge. A standard solution can create alignment between operational performance, quality management processes, and compliance needs.
Tenthpin Quality Management Evolved (T/QME) is a fully embedded and highly configurable standard solution designed specifically to enrich the existing SAP Quality Management module.
This product was created to be a bridge between regulatory requirements and a clean IT architecture. Developed to address critical Life Sciences’ requirements, it also operates natively within the SAP ecosystem.
T/QME helps your organization maintain a clean and manageable IT landscape by avoiding custom solutions, which are often the source of technical debt. Furthermore, its alignment with international standards ensures that organizations meet sector-specific compliance requirements, enhancing product quality and business performance.
Let’s explore how T/QME addresses the key challenges and transforms quality into a strategic advantage:
In Life Sciences, both the integrity and traceability of data are essential. Organizations and customers demand a clear, verifiable audit trail for every action. This is a requirement that traditional paper-based processes and fragmented systems struggle to meet.
T/QME is built to serve as a digital fortress for compliance and quality assurance. As part of this, adopting widely recognized frameworks (such as ISO 9001) enhances assurance in quality management practices, creating processes that ensure both customer satisfaction and product safety.
The solution includes built-in compliance features such as additional restrictions on changing batch data, digital signatures, and a central audit trail. The digital signature functionality satisfies legal criteria (such as 21 CFR Part 11) and adherence to federal regulations.
A central audit trail acts as a comprehensive, real-time log of every action, ensuring accountability and providing proof of compliance that simplifies regulatory audits and reduces the risk of human error.
Validation is one of the most resource-intensive aspects of Quality Management Solutions implementation, often characterized by complex testing and extensive documentation. T/QME changes this paradigm. Instead of building and validating a solution from scratch, organizations can leverage T/QME as a GxP-ready standard product.
This GxP-readiness, performed according to rigorous standards, shifts the focus from the fundamental system validation to a more manageable and customer-specific configuration validation. This allows your quality assurance teams to focus on verifying that the system, as configured, meets your specific business processes and product requirements, drastically reducing the validation workload.
To further accelerate this process, T/QME streamlines documentation and includes automated test scripts that can generate critical compliance reports and documentation with minimal manual effort.
Traditional risk management often operates in a reactive mode, addressing problems after they occur. T/QME enables a proactive approach by leveraging real-time data to provide quality intelligence. The solution provides configurable dashboards that offer real-time visibility into operational vulnerabilities and KPIs - Key Performance Indicators.
The dashboards act as a central hub for risk intelligence, offering instant insights into quality performance. This feature enables decision-makers to identify issues and address them immediately before they can escalate into regulatory problems or costly recalls.
With T/QME, your organization not only reduces the risk of non-compliance, but also ensures continuous improvement.
The decision to embrace a standard solution like T/QME is a long-term strategic choice. While custom-built solutions may appear cost-effective upfront, their maintenance, validation, and compliance costs can lead to a significantly higher Total Cost of Ownership (TCO).
T/QME, as a standard add-on for SAP S/4HANA, offers a high degree of investment security. It is subject to continuous, long-term development by Tenthpin, ensuring you benefit from a robust roadmap that automatically incorporates industry best practices, new technologies, and evolving regulatory updates.
This vendor-led innovation helps your company improve system efficiency by freeing IT teams from the burden of building and maintaining custom code. Now, they can instead focus on strategic initiatives that truly drive business value and operational excellence.