Compliance by Design: GxP-Ready Software for Life Sciences Industry

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.

Unlocking GxP-ready software: How we keep Life Sciences ahead

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.

Why software qualification in Life Sciences matters

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.

Empowering compliance through innovation: T/QME, T/ICV, and T/ICG

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.

Continuous improvement and refining Tenthpin’s processes

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.

De-risking AI with compliance and best practices

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.

Bringing efficiency and flexibility to certificate automation

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.

How Tenthpin qualifies software: A methodical approach

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:

• Adherence to GxP and industry standards: From the very beginning, we align our development processes with industry-specific guidelines. This way, regulatory compliance is not only considered but built into the software from the ground up.
• Risk-based qualification: We take a risk-based approach, focusing on identifying, assessing, and mitigating risks associated with software functionality. Critical areas are subjected to stringent qualification, while less critical aspects receive appropriate oversight, promoting efficiency and effectiveness.
• Continuous design reviews: To maintain quality and compliance, Tenthpin conducts continuous design reviews throughout development, assessing each stage to verify alignment with regulatory and quality expectations. This helps identify potential issues early for timely adjustments.
• Comprehensive testing framework (manual and automated): We implement extensive functional and non-functional testing, including installation qualification, unit testing, integration testing, security testing, performance testing, and user acceptance testing (UAT), ensuring our software behaves as expected under all conditions.
• Detailed records and traceability: Our documentation provides full traceability, ensuring decisions and actions are transparent and auditable. This brings our clients peace of mind during validation and inspections.
• Client-centered collaboration: We understand your unique validation requirements and work closely with you to tailor our qualification efforts, reducing your validation burden, but still achieving compliance.
• Continuous improvement and monitoring: Even after deployment, we monitor software performance in live environments. Regular evaluations and feedback loops enable us to improve our processes, upholding ongoing compliance and reliability. We continuously adapt our products to your evolving requirements with regular new releases.

The benefits: What our qualification process delivers

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:

1. Compliant, GxP-ready software: Our software is fully qualified to meet GxP compliance and other standards (FDA 21 CFR Part 11, GDPR, EU AI Act, HIPAA). It’s ready for regulated environments so you can focus on your operations without compliance concerns.
2. Comprehensive documentation: Each product comes with complete documentation outlining our quality assurance framework, providing you with validation and audit evidence.
3. Tailored qualification packages: Tenthpin offers customized qualification packages aligned with your requirements, including setup plans, test cases, manuals, and release notes. This way, your Life Sciences company is offered everything needed for efficient validation.
4. Continuous qualification for SaaS products: For SaaS, we partner with P36 to manage continuous qualification via their Cloud Service Qualification Platform, with regular reports keeping you informed of the platform’s qualified state.
5. Risk-managed solutions: Our risk-based approach identifies and addresses potential issues early, ensuring thoroughly tested, qualified products while minimizing validation effort and system failure risks.
6. Seamless integration with client validation: While you, as a client, remain responsible for final validation, our qualification processes are designed to integrate smoothly with your existing validation frameworks. This reduces your workload and ensures that our software supports your compliance objectives from the start.

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.