Make or Buy? Your SAP Clean Core Decision Guide

If you lead technology or quality initiatives in Life Sciences, you likely envision unique workflows, specialized reports, or a quicker method to transfer essential data within your Quality Management System. Maybe your internal IT team has developed a tailored solution that feels right, offering precise control and tailored functionality.

But as your business expands, change occurs. Those earlier beneficial custom solutions become difficult to maintain, challenging to update, and increasingly incompatible with SAP Clean Core principles.

You find yourself at a crossroads: will you keep investing in those tailored solutions, or will you adopt standard Quality Management System solutions that align with the SAP Clean Core strategy?

The hidden costs of "Making It Yourself”

When we think back to the early days of digitalization, custom-built Quality Management Systems felt like the answer, offering control and flexibility for Life Sciences’ unique processes. But over time, these bespoke QMS developments often transform into what is known as "technical debt." Your IT team now dedicates endless hours to fixing and maintaining elements that were never genuinely prepared for sustainable growth.

More than a depletion of your top talent, the tailored QMS solutions also establish unseen barriers. Quality data becomes trapped in separate systems, forcing manual transfers that are inefficient and susceptible to human error (a significant issue in sectors like pharma and biotech).

When it's time for a crucial SAP upgrade, these customizations make it nearly impossible to maintain SAP Clean Core principles. The integration between your customized system and core SAP functionality becomes increasingly complex and expensive. Even the smallest modification in your QMS initiates extensive validation processes, placing a significant strain on your quality assurance teams.

The importance of SAP Clean Core for Life Sciences

If you have already encountered challenges with your highly tailored ERP environment, SAP Clean Core may be the answer. This strategy provides a transparent, sustainable route ahead, facilitating modernization and positioning your organization for future expansion and innovation.

In 2025, SAP indicated that adopting a Clean Core strategy can significantly reduce upgrade efforts while enabling continuous innovation. Here are some of the most important advantages of implementing a SAP Clean Core approach:

• Quicker and simpler updates: Faster SAP updates and access to additional features.
• Streamlined compliance and verification: Reduced validation complexity and easier regulatory compliance.
• Smooth integration with tailored solutions: Reliable integration of custom-designed / modular solutions.
• Enhanced global consistency: The uniformization of processes reduces complexity and risk.
• Good foundation for advanced data analysis and Artificial Intelligence: Only reliable data from a clean system can support advanced analytics and AI.
• Agility and innovation readiness: A streamlined SAP core allows for quick adjustments to market and regulatory shifts.

Sustaining a clean core in SAP allows for effective integration and expansion of specialized solutions within your Life Sciences organization. For example, it ensures that Quality Management Systems functions effectively within your SAP environment, using advanced features while maintaining your operations efficient, compliant, and prepared for future growth.

The viewpoint of Total Cost of Ownership (TCO)

When evaluating the “make vs. buy” decision, companies tend to focus solely on the upfront cost of developing a custom solution versus purchasing a standard one. However, a true understanding of Total Cost of Ownership goes far beyond initial costs: it considers the entire solution lifecycle.

This perspective is especially important when considering Quality Management Systems, where hidden costs in maintenance, compliance, and system upgrades can significantly impact long-term investment.

The accumulation of technical debt in custom QMS solutions has a compounding effect on TCO. The more custom code and fragmented QMS components an organization maintains outside SAP Clean Core guidelines, the higher these ongoing costs become.

Over the full lifecycle, custom-built QMS approaches consistently carry a significantly higher TCO compared to adopting standard solutions that align with your SAP Clean Core strategy.

The following table provides a comparative overview of the TCO and strategic impact of custom versus standard solutions:

SAP Clean Core alignment and Quality Assurance excellence

Quality Management Systems that ignore SAP Clean Core principles frequently make QA a challenging bottleneck. Essential quality information becomes confined within separate tools, hindering decision-making and clouding a comprehensive perspective on quality performance.

In opposition, conventional Quality Management Systems tailored to the SAP Clean Core strategy significantly streamline QA processes. They offer instant visibility into your quality processes, delivering prompt insights into quality data while ensuring core integrity. Automated documentation and audit trails minimize manual work, ensuring comprehensive records for compliance without compromising SAP Clean Core principles.

Built-in workflows also simplify deviation management in your QMS, resulting in faster resolutions while ensuring smooth connectivity with your core SAP ecosystem. By removing quality data silos and enhancing data flow with SAP Clean Core-compatible architectures, these conventional solutions accelerate batch release, directly impacting operational efficiency.

Embracing best practices with standard solutions

Standard QMS solutions designed to align with SAP Clean Core strategies directly tackle the issues presented by Quality Management while preserving the specific features needed for quality processes in Life Sciences. Implementing standardized QMS platforms that align with SAP Clean Core principles can release important IT resources, enabling your teams to transition from reactive problem-solving to strategic quality efforts.

Tenthpin Quality Management Evolved (T/QME), from Tenthpin, is an example of a solution that incorporates the best practices aligned with Life Sciences’ specific needs, greatly minimizing validation and compliance efforts. Simultaneously, it allows you to preserve SAP Clean Core integrity. This built-in standardization reduces the Total Cost of Ownership throughout the complete Quality Management System lifecycle.

Furthermore, T/QME naturally promotes agility, enabling rapid adaptation to changing regulatory requirements, market needs, or internal quality standards. It enables smooth upgrades in SAP S/4HANA environments, guaranteeing you can continuously utilize the newest features without affecting your quality processes.

Standard solutions: the best of both worlds

The concealed expenses, operational constraints, and regulatory difficulties associated with tailor-made Quality Management Systems can greatly hinder progress, particularly when they conflict with SAP Clean Core principles. Standard solutions, in contrast, directly address these challenges while positioning your organization for agility, scalability, and future-readiness.

Standard solutions resolve the challenges of complicated updates and the burdens of manual compliance while guaranteeing smooth integration with your SAP environment. By utilizing standard integrations and interfaces, updating essential components (such as your ERP system) becomes simplified in a sustainably maintained clean core atmosphere.

Implementing standardized solutions aligned with SAP Clean Core, such as T/QME, enables your organization to transition to a future-oriented environment. Move forward with confidence, achieving exceptional quality processes while ensuring compliance, efficiency, and rapid innovation capabilities.