Building life-saving products in Life Sciences requires more than breakthrough science and innovative design. It requires the confidence that every step, from research to manufacturing, is underpinned by a reliable, compliant Quality Management System (QMS) you can trust.
For Tenthpin, qualification is not a checkbox, but a mindset. By embedding qualification into every stage of the software development lifecycle, we help you minimize risks, deliver consistent quality, and stay GxP-ready while you focus on what truly matters: bringing high-quality therapies and medical technologies to patients faster.
Software plays a critical role in developing, producing, and supplying life-saving products, so getting it right from day one is non-negotiable. That is why, at Tenthpin, we focus on developing GxP-ready software that fits seamlessly into your operations, letting you focus on your core business with the confidence that you remain compliant.
The good news is that achieving compliance doesn't have to be an overwhelming burden. We have created a robust qualification process that helps reduce the validation load on our clients. You can now meet your regulatory requirements with ease when using Tenthpin Intelligent Quality Suite.
In pharma, medtech, and other heavily regulated industries, software supports every process, from research and development to manufacturing and distribution. And for Life Sciences companies, compliance is a must. When software fails during productive use in those sectors, the consequences can be catastrophic. One example is using corrupt or erroneous data for GxP-related decision making, which can result in product recalls, penalties, wasted investments, or even reputation damage.
In Life Sciences, staying compliant requires more than meeting regulatory standards in the product development process. That’s why we developed three industry-specific, compliant, and innovative software products: Tenthpin Quality Management Evolved (T/QME), Tenthpin Intelligent Certificate VerificAItion (T/ICV), and Tenthpin Intelligent Certificate Generation (T/ICG). These solutions are part of Tenthpin’s Intelligent Quality Suite, and they are designed to support your complex needs.
T/QME is our answer to the unique quality management system challenges in Life Sciences. Running on SAP S/4 HANA, T/QME enhances the existing SAP Quality Management module, providing you with a tailored quality management system covering critical quality assurance and control processes. With T/QME, compliance becomes a natural outcome of daily operations. We aim to enable Life Sciences organizations to maintain high-quality standards while adhering to regulatory requirements.
T/QME was the first software product we built, qualified, and deployed using our systematic software development lifecycle process. It was essential for us to deliver a product that meets the unique needs of Life Sciences. The experience we gathered in designing, developing, qualifying, and deploying T/QME has been invaluable.
As part of our commitment to transparency and quality, we grant you the right to audit our development processes. Past audits with our T/QME clients have gone smoothly and provided constructive feedback that confirms the strength of our qualification framework. We also welcomed observations and suggestions, which offered opportunities to adapt our software development lifecycle further. This feedback loop is integral to how we continuously improve our processes, making sure that all our software solutions remain at the forefront of compliance and reliability.
T/ICV is our AI-driven solution that accelerates manual compliance tasks by 95% and more. T/ICV automates the extraction and comparison of data from Certificates of Analysis (CoA), Certificates of Sterilization (CoS), and Certificates of Conformity (CoC) against specification documents. This reduces your team’s time spent on these tasks, minimizes human error, and ensures data accuracy, allowing you to focus on delivering life-saving products faster and more efficiently.
AI-driven solutions like T/ICV remain a critical focus in the highly regulated Life Sciences industry. To harness the opportunities of AI while addressing validation concerns, we have embedded a risk-based approach throughout T/ICV’s development.
First and foremost, we ensure compliance with key regulatory frameworks, such as the EU AI Act, and adhere to industry best practices outlined by organizations like ISPE. By proactively considering these guidelines, we design our AI solutions to align with regulatory requirements from the beginning.
Additionally, we implement a robust risk mitigation strategy throughout the SDLC, following proven principles for AI-driven products (explain-ability, transparency, auditability). This approach ensures that while T/ICV delivers cutting-edge AI performance, it also adheres to the strict compliance standards you expect, minimizing potential risks associated with AI adoption.
T/ICG is a flexible, GxP-ready cloud solution designed to streamline your certificate generation process. It ensures that the correct certificate is created with accurate data and delivered to the right destination at the right time. T/ICG offers robust configuration capabilities, allowing you to tailor certificates to your specific needs, like drawing data from numerous sources and varying certificates by market or individual customer requirements.
This solution significantly reduces the need for manual intervention in certificate generation, potentially by up to 100%. Full automation minimizes the risks and efforts associated with this typically time-consuming and error-prone process. T/ICG also provides comprehensive tracking of all certificate activities (whether generated, printed, reprinted, stored, automatically created, or manually generated), and offers detailed insights into the metadata used, allowing you to view all stored certificates at any time.
Data integrity was a non-negotiable aspect during the development of T/ICG, as it processes regulated data from multiple sources and triggers critical downstream actions like certificate generation, printing, and storage. For this purpose, we have implemented strict controls in the software to ensure that data remains complete, consistent and accurate at every stage. These include validation of input data, traceable data transformations, and built-in safeguards to prevent unauthorized changes. Furthermore, custom audit trails are a key element in T/ICG’s design. They meticulously capture not only who performed an action and when, but also the full context of certificate generation (including source systems, data used, and any configuration settings that influenced the output). This level of traceability is crucial in GxP environments, supporting both internal quality assurance and regulatory inspections.
By embedding compliance into our product development with T/QME, T/ICV, and T/ICG, we help you stay ahead of industry regulations while focusing on your core business.
At Tenthpin, we employ a systematic qualification process throughout the entire software development lifecycle. More than confirming that our solutions meet regulatory requirements, we aim to meet the highest standards of quality that our clients expect. Here is how we deliver that for you:
Through our qualification framework, we aim to provide you with solutions that meet regulatory requirements while optimizing validation processes. Here’s what you can expect:
With Intelligent Quality Suite, we offer a holistic approach to GxP compliance, designed to integrate seamlessly with your operations and minimize the effort required for validation.