T/ICG: Ensure Faster Batch Release With Intelligent Certificate Generation

While a batch awaits the assembly and approval of documents, it is hindered by institutional inertia, obsolete processes, and fragmented systems. During this wait time, there is no launch, no delivery, and most of all, no access for patients.

At Tenthpin, we specialize in solutions for Life Sciences. We know that manually generating CoA and CoC in large numbers is time-consuming and prone to errors. That’s why we developed Tenthpin Intelligent Certificate Generation (T/ICG): to automate and harmonize the certificate generation process. 

T/ICG not only increases supply chain efficiency, but also ensures a faster product batch release with automation and flexibility.

The hidden costs of manual certificate generation

Certificate generation is a critical part of the batch release process in Life Sciences. It ensures compliance and safeguards the quality of the treatments delivered to patients.

Yet, many organizations still rely on manual methods that slow them down and introduce risk at the final step of the batch release. According to the 2025 State of the Nation Recall Index by Sedgwic, “failed specifications” remain the top cause for product recalls in Pharma. At the same time, recent data from SAP reveals that nearly half of Life Sciences companies still use manual processes for batch release, and over a third rely on disconnected systems to do it.

This scenario creates unnecessary bottlenecks, increases the chance of human error, and puts additional pressure on quality teams. Aware of these concerns, we developed T/ICG to eradicate these challenges and setbacks.
 

How Intelligent Certificate Generation is revolutionizing batch release 

T/ICG goes beyond being merely a document automation tool. It’s a conversion layer that resides centrally within the batch release procedure. 

Designed specifically for Life Sciences’ organizations, T/ICG integrates seamlessly with SAP S/4HANA, LIMS, and MES systems. It addresses common challenges faced by organizations using SAP-based environments, such as manual data handling, system fragmentation, and delays in certificate generation. As part of Tenthpin’s Intelligent Quality Suite, T/ICG plays a pivotal role in improving efficiency across Quality Management processes.

T/ICG streamlines the certificate process by:

• Detecting when a batch passes QA, and starting certificate generation immediately
• Extracting data from different systems, validating it, and formatting it to meet local compliance needs
• Generating documents in seconds
• Issuing certificates through automated approval workflows with full audit trails and digital signatures
• Delivering the final documents to the right stakeholders in a fast and fully traceable manner

No more need for re-keying. No formatting tricks. It’s a smart system that handles time-consuming tasks that highly qualified employees shouldn’t need to do, allowing them to be more productive.

When speed becomes an ethical issue  

Balancing speed and thoroughness is a constant challenge in healthcare, medtech, and other related fields. Although scientific rigor is non-negotiable, postpones are often caused by operational inefficiencies. And when the delays affect product availability, they raise more than technical concerns.

The quality function can be deeply impacted by several industry challenges:

• When systems don’t “talk” to each other, data is spread across ERP, LIMS, MES, and even spreadsheets, making it hard to track and control
• Manual work leads to frequent mistakes and audit issues
• Strict documentation rules and tight deadlines represent constant pressure
• Missing or inconsistent data can result in costly recalls
• Highly skilled people spend too much time on administrative or repetitive tasks instead of focusing on quality improvement
   

These pain points converge in the batch release process, a critical step that must balance agility, precision, and compliance. When deferrals occur, they can affect the availability of essential medicines, many of which are already in short supply or depend on tight delivery schedules.

In this context, every delay counts, especially for life-sustaining treatments, chronic condition therapies, or critical care drugs where stock levels are often low and demand is continuous. 

At Tenthpin, we believe that ensuring timely batch release is a matter of public health and patient well-being.

How quality teams in Life Sciences can reclaim their time 

What occurs when the creation of certificates turns into a seamless procedure, and quality teams are freed from manual, time-consuming tasks? 

Instead of chasing paperwork, they can refocus their time and expertise on what truly matters, whether that is ensuring product quality, accelerating batch release, or driving continuous improvement.

Rather than dedicating 40% of their week to monotonous administrative tasks, they can focus on supervision, inquiry, and ongoing enhancement. Decision-makers can stop wondering when the certificates will be ready, and instead start asking: “What else can we improve?”.

In its 2024 industry forecast, SAP highlights some priorities for modernizing batch release, such as the digitization of processes and the implementation of a centralized cloud hub. T/ICG delivers exactly that by:

• Converting every phase of certificate creation into a fully digital process
• Connecting directly with SAP, LIMS, and QA systems for a unified, 360° view
• Using rule-based logic and intelligent workflows to tailor certificates to the specifics of each batch
   

With T/ICG, quality teams gain a cohesive, “control tower” perspective across systems.

According to SAP, digitalizing batch release can decrease review cycles by more than 90%. This results in quicker access to products, reduced recalls, decreased expenses, and improved results for patients.
 

Every minute matters

In heavily regulated industries, delays in documentation aren't merely an inefficiency in processes, but a systemic weakness. 

T/ICG mitigates this risk by implementing structure, consistency, and traceability in one of the essential final stages of batch release. Organizations can now transition from disjointed, manual processes to a regulated, rules-driven system that adapts to an increasingly complex environment. 

With T/ICG, certificate information is extracted  from various systems, validated, formatted, and routed without disruption. This supports compliance, reduces rework, and accelerates batch release time. 

As quality regulatory demands increase and international operations widen, manual certificate creation is no longer sustainable. With T/ICG, you can turn a weak point into a competitive advantage.