How Tenthpin Reinvented QA and QC in Life Sciences

From lab testing to batch release, Life Sciences companies encounter a complex web of manual data transfers, unintegrated systems, regulatory challenges, and documentation requirements that frequently hinder decision-making and elevate risk.

At Tenthpin, we believe it’s time for a new quality paradigm: one that connects lab data, automates compliance, and embeds QA/QC into the heart of business operations.

Reinventing quality in Life Sciences through digitalization

In Medical Technology and other healthcare sectors, scaling quality processes across global operations remains a complex goal. This results in operational bottlenecks, duplicated efforts, and missed opportunities to accelerate product availability and improve collaboration.

With growing pressure to accelerate product availability and streamline operations, Quality Assurance (QA) and Quality Control (QC) roles are expected to deliver more, focusing not only on compliance but also on business value. 

There seems to be a need for a digital modernization of the entire quality process, which begins in the laboratory and concludes with the release of a compliant, traceable product batch.

The frictions of the traditional quality journey

To grasp the effects of digitalization, we need to recognize the limitations of traditional systems.

A standard quality process in Life Sciences encompasses various departments and systems: 

• Testing is conducted in the lab
• Documentation is assessed by QA
• Deviations are handled elsewhere
• Batch records frequently reside in separate systems

Let’s analyze some practical examples of issues that may arise in a Biotech or CDMO company:

Laboratory manual data input

Many organizations still depend on spreadsheets, paper documents, or outdated tools for handling laboratory data. This not only creates opportunities for transcription mistakes but also complicates the preservation of a centralized audit trail.

Disparate systems

Often, the Laboratory Information Management System (LIMS) remains unlinked to the ERP, creating a significant gap between lab testing and critical decision-making. This issue is frequently worsened by legacy LIMS that require replacement, or the complex migration to SAP S/4HANA necessitating a new system with substantial implementation effort and expense.

Furthermore, for some businesses, the acquisition and maintenance of a dedicated LIMS may be viewed as too costly for their scale, leading to the reliance on inefficient manual processes. These fragmented approaches mean that laboratory results require tedious exportation, evaluation, and manual re-entry into QA systems or other ERP modules, significantly prolonging cycle times and heightening the risk of errors.

Management of deviation or change

When a deviation happens (whether in sampling, testing, or manufacturing), monitoring and addressing it can turn into an administrative headache. Various teams frequently utilize different tools and processes, which can slow down and segment root cause analysis.

Lack of real-time visibility

This is, perhaps, one of the most harmful constraints. In the absence of immediate access to laboratory data, test outcomes, and batch statuses, QA teams frequently depend on emails, PDF reports, or meetings for updates, resulting on delays and prolonged release times.

As we can see, relying on isolated or partially integrated systems at each stage of the quality process will often lead to fragmented information and operational delays.

Digital transformation in quality operations

Currently, forward-thinking Life Sciences companies are utilizing unified, smart platforms to enhance quality efficiency. These platforms exceed the conventional LIMS system, uniting lab operations, deviation monitoring, documentation, and batch release processes into one digital thread.

Some of the advantages of these platforms are:

• Quicker transition from product testing to market release
• Decreased human mistakes
• Automated records and audit logs
• Uniform implementation of quality policies and procedures
• Prompt notifications and measures in the event of deviations.

But the potential benefits of the innovative platforms extend beyond the laboratory. By incorporating quality operations into the fundamental systems of the enterprise (such as ERP), organizations can weave quality throughout the whole supply chain, from incoming raw materials to the delivery of the final product.
 

From isolation to collaboration: a fresh quality operating framework

Envision a day in the life of a pharmaceutical quality team functioning on a unified digital framework:

• Sample requests and test scheduling are initiated automatically from the ERP system according to batch data
• Laboratory technicians carry out tests through structured digital workflows, while the Batch Management System records every data point instantaneously
• When a result is outside the specifications, a deviation workflow is immediately activated, incorporating predefined roles, escalation protocols, and resolution templates
• QA can track batch status at any moment, examine lab data without changing platforms, and authorize release via a single interface

This is now a feasible operational model, rather than merely a distant concept. As  companies adopt this strategy, quality shifts from a cost center to a value-generating asset.

Why integration is key to global quality

For Life Sciences companies, scalability and compliance are interconnected. Each new site, product range, or regulatory area increases complexity. Manual processes are unable to keep pace. Occasionally, even Quality Management System (QMS) tools lack SAP integrations or were not designed specifically for the Life Sciences industry.

This is why end-to-end integration is becoming a crucial differentiator. It minimizes handoffs and human mistakes while offering a uniform and compliant basis for operations in various regions. Real-time quality information transforms into a valuable resource for manufacturing, supply chain, and R&D, facilitating quicker decisions and ongoing enhancement.

But how can Life Sciences organizations effectively achieve this crucial level of integrated quality, particularly within their core enterprise systems? That’s why we created Tenthpin Quality Management Evolved (T/QME).
 

T/QME, an integrated quality solution for Life Sciences in SAP

The answer lies in a purpose-built solution designed by Tenthpin to drive that essential transformation: T/QME, specifically tailored for the Life Sciences sector and completely integrated with SAP.

T/QME is not a standalone LIMS or external quality tool. It is an SAP-native solution that embeds quality processes into the core of the business. From sampling and testing to deviation management and batch release, every step becomes connected, auditable, and accessible in real time.

Using T/QME, organizations can effortlessly incorporate every aspect and process of QA and QC into their SAP system. This implies that test findings, variations, change management, and batch release determinations are seamlessly integrated into the ERP, establishing a genuine unified source of information.

The thorough integration allows immediate visibility and functionality throughout the whole supply chain, ranging from material intake to the launch of the final product. All of this while ensuring complete adherence and tracking.

As Stefan Kubick, Partner at Tenthpin Management Consultants, puts it:

“By integrating quality processes in ERP, leveraging the latest technologies and using industry best-practices, our solution is supporting a seamless integration of the QC and QA activities into the end-to-end supply chain process to stay ahead in today's competitive business landscape.”

The transition from lab testing to lot approval doesn’t need to be a disjointed, manual procedure anymore. By utilizing the appropriate digital infrastructure (alongside suitable partners), businesses may link the various components of QA, QC, and the larger supply chain.

More than just operational, the potential benefits of this transition are strategic: 

• Quicker release intervals
• Reduced compliance risks
• Enhanced cooperation among teams
• And a strong, data-informed quality culture