GxP projects - QFINITY
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A look inside our project work.

An overview of the projects QFINITY takes on for its clients - a look at how we work and at the projects we have already delivered in the GxP-regulated environment.

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Projects from the regulated environment.

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

Validierung KI-gestuetzter computergestuetzter Systeme - QFINITY

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.

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

Validierung eines Studienmanagementsystems - QFINITY

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.

A validation framework only holds once the team understands it and lives it day to day.

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?

  • QFINITY developed and implemented a validation framework tailored to the customer’s specific requirements. Beyond adapting the framework, the implementation included extensive training and ongoing project support for the customer’s employees. These measures gave the customer team a thorough grounding in the newly introduced processes and regulatory requirements. Active cooperation at all levels also strengthened acceptance and understanding of the various controls and processes, embedding the framework sustainably in the daily routine.

What steps were taken in the project to ensure compliance with applicable requirements and best practices?

  • Throughout the project, QFINITY continuously advised the client’s team on current requirements and best practices to ensure compliance with all relevant standards. This included implementing and validating a study management system and qualifying the infrastructure. QFINITY also supported the project team with supplier qualification and the associated documentation. The focus was on advising the team on quality management, CSV, and GxP processes, and on developing and implementing the validation strategy and creating the necessary validation documentation.

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.

Creation of a global quality management system

Globales Quality Management System - QFINITY

A globally positioned service provider, grown through acquisitions, needed a single QMS for IT and computerized systems. QFINITY harmonized the processes in line with GAMP 5 and ITIL – from concept through the design and documentation of individual processes to a global rollout with workshops and training materials.

The project

This project centered on creating a global quality management system.

QFINITY supported a global service provider that had grown significantly through acquisitions in harmonizing and rolling out a uniform quality management system worldwide, covering all areas of IT and computerized systems.

This covered processes and services in infrastructure management, software development and the implementation of computerized systems. Because the service provider’s portfolio includes products and services in all GXP areas, the approach had to satisfy all relevant regulations. The quality management system also had to build on standards such as GAMP 5 and ITIL. QFINITY helped develop the QMS concept and design and document the individual processes within it. QFINITY also supported the global rollout with training materials, workshops and targeted consulting for individual areas.

Harmonization succeeds with a ‘best of breed’ approach – it builds on what works and earns acceptance.

The goal

The project’s overall objective was to develop, harmonize and implement a comprehensive, uniform Quality Management System (QMS) worldwide. The system was designed to cover all areas of IT and the computerized systems used throughout the company, so that the same quality standards would apply worldwide. All departments and locations were to benefit from consistent, optimized processes. The QMS was meant to provide a basis for standardizing quality processes, increase efficiency within the IT structure and at the same time keep all technical processes reliable and stable.

A particular focus was developing a flexible QMS that could adapt to the specific requirements of different IT areas – without compromising global standards or regulatory requirements. Central harmonization makes processes and guidelines more transparent, which supports the company’s continuous improvement process. Training and clear instructions were to enable all employees, regardless of location or IT department, to use the system efficiently and correctly.

Beyond increasing efficiency and compliance with global quality standards, the project minimizes the risks that country-specific deviations in the IT infrastructure could create. The new QMS thus serves as a global reference framework that ensures a high level of quality, security and consistency across all company processes. This lets the company respond with greater agility to regulatory and technological change.

Any questions about creating a global QMS?

What are the critical success factors when implementing a global QMS?

  • The following factors are of particular importance when implementing a global QMS:
  • Support from all relevant stakeholders, especially management: implementation only succeeds if everyone involved knows it is being carried out on behalf of and with the backing of management. Everyone also needs to understand why a harmonized Quality Management System is being implemented. The reasons may include
    • To ensure regulatory compliance
    • to fulfill customer expectations
    • and thus ensure the long-term success of the company.
  • Training and consulting for all affected areas: Creating and implementing the relevant standard operating procedures is only a first step in implementing a Quality Management System. The affected departments and their employees need thorough training in the new processes and the requirements behind them. Some areas may also need individual consulting services, for example to establish initial compliance for complex and critical systems.

What initial obstacles do you have to expect in a project like this?

  • One initial obstacle is the different terminology established in individual areas. A universally recognized glossary helps overcome misunderstandings and terminology problems.
    It also pays to analyze the existing quality management processes and find a balanced “best of breed” approach that picks up processes already established in parts of the company, harmonizes them and then rolls them out across the entire company. This increases acceptance among employees, as they recognize at least parts of their familiar processes.

Do you need help with a similar project? Then please contact us using our contact form. You can find more information about our services under Service – feel free to take a look.