Validating GxP Systems With AI Components

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.

AI in regulated environments succeeds only with precisely aligned processes – not with technology alone.

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?

The main objective 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 assessing and revising the existing standard operating procedures (SOPs) and templates. The adjustments took into account the company’s size, growth strategy, and the specific requirements of a medium-sized pharmaceutical company.

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

QFINITY conducted employee training and provided continuous coaching throughout the project. It also supported the project team with supplier qualification and the related documentation. A particular focus was advising the team on quality management, CSV, and GxP processes, and on developing and implementing the validation strategy and creating the necessary validation documentation.

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