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

The project

This project involved the introduction and validation of a high-performance AI and analytics platform and the development of a framework for the validation of computerized systems with AI components.

The first step was a review of the CSV processes, including a review and revision of the existing SOPs and templates, adapted to the company size, growth strategy and specific needs of the client. 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. The project team was supported in the areas of quality management, CSV and GxP processes as well as in the development and implementation of the validation strategy and the creation of validation documentation.

The goal

This project aimed to validate an innovative high-performance AI and analytics platform that would serve as a solid and powerful foundation for the development and implementation of customized AI solutions specifically for the client. This platform should not only offer high computing power and analytical capabilities, but also be flexible and adaptable to best meet the specific requirements and expectations of different customers.

An important part of the project was the detailed review and careful customization of the Computer System Validation (CSV) processes, Standard Operating Procedures (SOPs) and templates to adapt them to the client’s specific needs and operational processes as well as to the particular requirements of AI systems. The integration of AI in regulated environments poses particular challenges that can only be mastered safely through precisely coordinated processes and documentation.

QFINITY not only took on a consulting role in the field of CSV but was also responsible for conducting extensive training sessions and hands-on coaching to familiarize the client’s team with the requirements and intricacies of CSV. Another focus was on supporting supplier qualification to ensure that the technologies and services used met all relevant standards and quality requirements.

Additionally, the project team received comprehensive support in the areas of quality management, CSV, and GxP processes to ensure a high level of compliance and efficiency. The close collaboration between departments and the integration of specialized expertise in GxP compliance, quality assurance, and computer system validation made it possible to deliver a state-of-the-art, compliant platform that meets the client’s operational needs and forms the foundation for forward-looking AI solutions.

Any questions about the validation of computer-based systems with AI components?

What were the central goals of the project to validate the high-performance AI and analytics platform?

• The main objective of the project was to validate an innovative high-performance AI and analytics platform and to enhance the existing validation strategy by incorporating specific aspects of artificial intelligence. This included a detailed review of the CSV processes, including the assessment and revision of existing standard operating procedures (SOPs) and templates. Adjustments were made with consideration of the company’s size, growth strategy, and the specific requirements of a medium-sized enterprise in the pharmaceutical sector.

What additional supportive measures did QFINITY implement as part of the project?

• QFINITY conducted employee training and provided continuous coaching throughout the project. Additionally, QFINITY supported the project team with supplier qualification and the related documentation. Particular focus was placed on advising and assisting the team in the areas of quality management, CSV, and GxP processes, as well as developing and implementing the validation strategy and creating the necessary validation documentation.

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