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Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
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New at QFINITY: Project News – Stay updated on our latest projects!
We are excited to introduce a new feature on our website! From now on, you can explore our Project News section, where we share insights into our ongoing and completed projects. We created this section to give our clients, partners, and anyone interested a better understanding of QFINITY’s diverse activities and innovative solutions.
Our goal with this new section is to offer you a comprehensive look at QFINITY’s work. The Project News section serves as a central hub for current and past projects. Whether you’re interested in validating computerized systems (CSV), implementing and optimizing GxP processes, qualifying suppliers, or building advanced AI and analytics platforms – our Project News delivers valuable information and success stories.
What can you expect in our new section?
Click here to visit our Project News section and stay informed about the exciting developments at QFINITY. We look forward to supporting you on your path to successful projects!
Development of a framework for the validation of computer-aided systems with AI components and introduction and validation of a high-performance AI and analytics platform
A mid-sized pharmaceutical company introduced and validated a high-performance AI and analytics platform. QFINITY extended the validation strategy to the specifics of computerized systems with AI components, revised CSV processes and SOPs, and supported training, supplier qualification, and validation documentation.
The project
This project involved introducing and validating a high-performance AI and analytics platform and developing a framework for validating computerized systems with AI components.
The first step was a review of the CSV processes, including revising the existing SOPs and templates and adapting them to the client’s size, growth strategy, and specific needs. The validation strategy took into account both traditional and agile software development methods and covered all phases of the system lifecycle.
QFINITY also provided employee training, coaching during the project, and support with supplier qualification and documentation. It advised the project team on quality management, CSV, and GxP processes, and helped develop and implement the validation strategy and create the validation documentation.
The goal
This project aimed to validate an innovative high-performance AI and analytics platform that would serve as a solid, powerful foundation for developing and implementing AI solutions customized for the client. The platform was to offer not only high computing power and analytical capabilities but also the flexibility and adaptability to meet the specific requirements and expectations of different customers.
An important part of the project was reviewing the Computer System Validation (CSV) processes, Standard Operating Procedures (SOPs), and templates in detail and carefully tailoring them to the client’s specific needs and operational processes – and to the particular requirements of AI systems. Integrating AI in regulated environments poses particular challenges that can be mastered safely only with precisely coordinated processes and documentation.
QFINITY not only advised on CSV but also ran extensive training sessions and hands-on coaching to familiarize the client’s team with the requirements and intricacies of CSV. Another focus was supporting supplier qualification to ensure that the technologies and services used met all relevant standards and quality requirements.
The project team also received comprehensive support in quality management, CSV, and GxP processes to ensure a high level of compliance and efficiency. Close collaboration between departments, combined with specialized expertise in GxP compliance, quality assurance, and computer system validation, made it possible to deliver a modern, compliant platform that meets the client’s operational needs and forms the foundation for forward-looking AI solutions.
Any questions about validating computerized systems with AI components?
What were the central goals of the project to validate the high-performance AI and analytics platform?
What additional supportive measures did QFINITY implement as part of the project?
Need help with a similar project? Feel free to contact us through our contact form. For more information about our services, visit our Service section. We’d love to assist you!
Development of a validation framework for computerized systems incl. introduction and validation of a study management system
A university hospital introduced a clinical study management system. QFINITY built a tailored validation framework, ran the vendor audit as part of supplier qualification, and continuously advised the study center on national and international regulatory requirements.
The project
This project at a university hospital involved introducing and validating a study management system, developing a framework for validating computerized systems, and training staff. A central component was a vendor audit, conducted as part of vendor qualification to ensure that all external providers met the required standards.
In addition, a customized study management system was introduced and validated to improve the efficiency and quality of the study processes. The study center received ongoing guidance on regulatory requirements and best practices throughout the project to ensure compliance with all applicable regulations.
The goal
Our main objective was to introduce and comprehensively validate a modern study management system that would significantly increase the efficiency and transparency of administrative processes within the study center. Particular attention went to advising the study center continuously on current regulatory requirements at both the national and international levels. The advisory work also ensured that the latest best practices in study management were always taken into account, enabling continuous improvement of internal processes and helping meet the required high quality standards. Another important element was ensuring that the system implementation stayed flexible enough to accommodate future regulatory changes and industry-specific developments.
Any questions about validating a study management system?
What measures were implemented at the customer’s site to successfully introduce a validation framework?
What steps were taken in the project to ensure compliance with applicable requirements and best practices?
Need help with a similar project? Contact us through our contact form. You can find more information about our services in the Service section – feel free to take a look.