ITM Isotope Technologies Munich AG ensures FDA Readiness with DHC VISION

ITM Isotope Technologies Munich AG is dedicated to the development, production, and global supply of innovative diagnostic and therapeutic radionuclides. A „digital turn” in quality management supports the company’s path toward business expansion, innovation, and economic growth. ITG Isotopes Technologies Garching, an ITM affiliated company, implements an integrated quality management system and thereby values DHC Business Solution’s regulatory compliance expertise.

Digital quality processes foster growth and create value

ITM AG increasingly focuses on developing innovative radio pharmaceuticals in addition to the production of radionuclides. This shift entails even more complex requirements for quality management as well as GMP-compliant production processes and sites. More complex regulatory requirements generally result in higher costs for compliance and quality in production. This, however, is what ITM is trying to avoid.

A gap analysis of the company’s FDA readiness identified potentials for more efficiency in quality management. “We are digitalizing all our quality management processes. This helps us tackling increasing GxP complexity at no additional costs,” explains Thomas Dürre, CFO at ITM. “We are aiming at corporate growth in processes that add value to our business instead of merely increasing G&A costs.” Alzebta Krempova, Head of Quality Assurance & Quality Management at ITM’s affiliated company ITG, highlights key advantages of the company’s new and digital quality management solution, which is based on DHC VISION: “Throughput times for GxP-related documents have decreased significantly. We also witness less manual resource input, higher process efficiency, and significantly lower risks.”

An integrated management system provides comprehensive quality support

DHC VISION Life Science is an industry solution for quality and compliance management. It covers core processes such as SOP and training management, including learning success management for detailed documentation of training results; it provides resources for CAPA, complaints, deviation and change management; and it facilitates digital process and audit management support. Core processes in these areas provide the basis for the integrated management system now in place at ITM. The solution also consolidates in a digital environment previously distributed and very often paper-based information sources which capture complaints, out of specification results, deviations in product quality, changes, measures, among many other compliance-related issues. Finally, ITM’s new digital quality management system replaces weekly quality meetings as the actual state of the quality system now can be inspected in real time whenever needed. “With DHC VISION we have a consistent and digital data basis with automated workflows and processes for document control. With DHC VISION, we are able to identify in a much more targeted way the areas where we have to take action and where interventions are needed,” explains Manuela Stocker, Deputy Head of QA &QM at ITG.

ITM’s decision to go for DHC VISION was the result of an intense selection process. “We were especially convinced by DHC VISION meeting most of our requirements and demands, in particular in combination with our efforts to secure overall GxP compliance. We also appreciated the system’s excellent usability and the very appealing system design,” Manuela Stocker explains.

Smart Validation ensures compliance with FDA and GxP regulations

DHC VISION is a GxP-related software system that needs validation before being used. Validation at ITM was based on DHC’s “Validation Accelerators”, i.e. a set of templates and process models that cover all steps of the validation process – from the validation plan to Part 11 analysis, user specifications (URS), test case definition, and the final validation report. Such templates are core to the process- and risk-based validation approach DHC generally follows; the approach has been widely adopted in chemical and pharmaceutical industries as it speeds up the validation processes and significantly reduces validation costs. With regard to system validation, Manuela Stocker explains: “DHC’s longstanding and broad validation experience was very convincing to us as were positive recommendations we received from other chemical and pharmaceutical companies already using DHC VISION.”

Dr. Wolfgang Kraemer, Managing Director at DHC Business Solutions, is looking forward to the long-term cooperation with ITM in implementing the company’s digital strategy. “We provide comprehensive cloud-based hosting and system operation services to ITM. We are extremely pleased with the increasing success of our business model, which is geared toward providing IT operations support to growth-oriented high tech companies with a clear strategic focus on ‘Quality 4.0’,” Wolfgang Kraemer explains.

About ITM

ITM Isotopen Technologien München AG is a privately held group of companies dedicated to the development, production and global supply of innovative diagnostic and therapeutic radionuclides and radiopharmaceuticals. Since its foundation in 2004, ITM and its subsidiaries have established GMP manufacturing and a robust global supply network of a novel, first-in-class radionuclides and -generator platform for a new generation of targeted cancer diagnostics and therapies. Furthermore, ITM is developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing a range of cancers such as neuroendocrine cancers or bone metastases. ITM’s main objectives, together with its scientific, medical and industrial collaboration partners worldwide, are to significantly improve outcomes and quality of life for cancer patients while at the same time reducing side-effects and improving health economics through a new generation of Targeted Radionuclide Therapies in Precision Oncology.

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About DHC Business Solutions

DHC Business Solutions is one of the leading providers of software solutions and consultancy services on the German-speaking market and in the area of quality and process management as well as in governance, risk and compliance. Company headquarters are located in Saarbrucken, Germany; DHC Business Solutions operates subsidiaries in Freiburg, Berlin and Rzeszóv, Poland. Numerous companies use DHC VISION to manage compliance with quality standards, norms and legal requirements and to manage increasingly complex regulatory demands. Simple, smart, small – this is the guiding thread for DHC when designing and delivering solutions and services for efficient handling of regulatory complexity.

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