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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Development of a validation framework for computerized systems incl. introduction and validation of a study management system

The project

This project, at a university hospital, involved the introduction and validation of a study management system, including the development of a framework for the validation of computerized systems and the training of staff. A central component was the implementation of a vendor audit as part of the vendor qualification process 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 of the project 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. As part of this project, particular attention was paid to ensuring that the study center was continuously and regularly advised on current regulatory requirements at both national and international level. In addition, the advice was to ensure that the latest best practices in the field of study management were always taken into account in order to enable continuous improvement of internal processes and to meet the necessary high quality standards. Another important element was to ensure that the implementation of the system is 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?

  • A validation framework was developed and implemented that was tailored to the customer’s specific requirements. In addition to adapting the framework, the implementation also included extensive training and ongoing project support for the customer’s employees. The aim of these measures was to provide the customer team with comprehensive training in dealing with the newly introduced processes and regulatory requirements. In addition, acceptance and understanding of the various controls and processes was to be strengthened through active cooperation at all levels in order to enable sustainable integration of the framework into the daily routine.

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

  • During the course of the project, the client’s team was continuously advised on current requirements and best practices to ensure compliance with all relevant standards. This included the implementation and validation of a study management system and the qualification of the infrastructure. In addition, QFINITY supported the project team in the qualification of suppliers and the associated documentation. The focus was on advising and supporting 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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Creation of a global quality management system

The project

This project involved the creation of a global quality management system.

QFINITY supported a global service provider, which had grown significantly through acquisitions, in the harmonization and global implementation of a uniform quality management system for all areas of IT and computer systems.

This included processes and services in the areas of infrastructure management, software development and the implementation of computerized systems. As the service provider has products and services in all GXP areas in its portfolio, an approach had to be found that satisfactorily supports all relevant regulations. Furthermore, the quality management system had to be based on standards such as GAMP 5 and ITIL. QFINITY supported the creation of the QMS concept as well as the design and documentation of the individual processes within the QMS. QFINITY also supported the global implementation with training materials, workshops and individual consulting services for individual areas.

The goal

The overall objective of the project was the development, harmonization and worldwide implementation of a comprehensive and uniform Quality Management System (QMS). This system was to be designed to cover all areas of IT and the computer systems used throughout the company. This measure was intended to ensure that the same quality standards were applied worldwide. It was important to ensure that all departments and locations benefit from the consistent and optimized processes. The QMS should create a basis that makes it possible to standardize quality processes. It should also increase efficiency within the IT structure and at the same time ensure operational reliability and stability in all technical processes.

A particular focus was on the development of a flexible QMS that could be adapted to the specific requirements of different IT areas. Care had to be taken to ensure that global standards and regulatory requirements were not compromised in the process. Central harmonization increases the transparency of processes and guidelines, which supports the company’s continuous improvement process. All employees, regardless of location or specific IT department, should be enabled to use the system efficiently and correctly through training and clear instructions.

In addition to increasing efficiency and compliance with global quality standards, the project is designed to minimize the risks that could arise from country-specific deviations in the IT infrastructure. The new QMS thus serves as a global reference framework that ensures that a high level of quality, security and consistency is achieved in all company processes. This enables the company to react more agilely to regulatory and technological changes.

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: successful implementation is only possible if it is clear to everyone involved that the implementation is being carried out on behalf of and with the support of management. In this context, the reasons and necessities for implementing a harmonized Quality Management System HS must also be clearly communicated to everyone. The reasons and necessities 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: The creation and implementation of the relevant standard operating procedures is only a first step for the implementation of a Quality Management System HS. The relevant departments and their employees must be comprehensively trained in the new processes and the underlying requirements. For relevant areas, it may be necessary to provide individual consulting services, for example to ensure 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 that is established in individual areas. The creation of a universally recognized glossary helps to overcome difficulties in understanding and terminology problems.
    Furthermore, it is advisable to analyse the existing quality management processes and find a balanced “best of breed” approach that takes up processes already established in parts of the company, harmonizes them and then rolls them out throughout the entire company. This increases the general acceptance among the employees in the company as they recognize at least parts of their familiar processes.

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INTRODUCTION OF A PARTICLE MONITORING SYSTEM IN A PHARMACEUTICAL PRODUCTION FACILITY

The project

QFINITY supported a manufacturer of pharmaceutical products in the implementation and validation of a computerized particle monitoring system.

This project included processes and services in the area of validation planning and execution. It also included the coordination and follow-up of documentation activities at the pharmaceutical company and the manufacturer of the particle monitoring system. The pharmaceutical company could only carry out the implementation in production within a limited time frame. Therefore, an approach had to be found that could be implemented within this time frame and would ensure the necessary conformity with all regulations. This required a detailed analysis of the system manufacturer’s documentation, including site acceptance testing. Based on this analysis, a highly efficient documentation approach could be defined for the implementation and release of the system within the specified time frame.

The goal

The aim of this project was the comprehensive introduction and validation of a particle monitoring system at a manufacturer of pharmaceutical products. Particular emphasis was placed on ensuring that the installation and validation of the system met the strict requirements of the pharmaceutical industry and complied with all relevant regulatory requirements. The new system was to enable continuous monitoring and analysis of particle contamination in order to ensure product quality and the safety of production processes. The implementation was carried out within a clearly defined timeframe to ensure operational continuity and compliance with the planned milestones.

This project served to ensure the highest quality standards, minimize risks and increase efficiency in the production of pharmaceutical products.

Still have questions about validating a particle monitoring system?

What are the critical success factors when implementing a PMS within the given timeframe?

  • The following factors are of particular importance when implementing a PMS.
    • Support from all relevant stakeholders: Successful implementation is only possible if all stakeholders are clear that the implementation validation must be completed within the given timeframe. In this context, it is imperative to review all documentation created prior to implementation and to evaluate which validation and documentation activities are already being carried out in the production area prior to implementation. The documentation generated by the system manufacturer should be used as far as possible.

What initial obstacles must be expected in such a project?

  • An initial obstacle is the different terminology that is established in individual areas and organizations. Open communication and the creation of a universally recognized glossary helps to overcome difficulties in understanding and terminology problems.
  • It is also advisable to check and approve the documentation promptly to avoid bottlenecks before the system is implemented in production.

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INTRODUCTION OF A DOCUMENT MANAGEMENT SYSTEM (DMS)

The project

This project is about the introduction of a document management system (DMS). QFINITY assumes the combined role of project manager and validation manager.

With the support of QFINITY, a system selection was carried out that ensured the requirements of all areas (company-wide) as well as inclusion in the selection process (user acceptance). The basis was a previously created, company-wide specification sheet. A clearly evaluated selection system was used to decide on a service provider (Oct. 2023) and the project was set up for a phased implementation. The aim was to reduce approval times, set up a collaboration platform with centralized access to all documents in the company, including validation, use of electronic signatures, full-text search, workflow support and the possibility of setting up further solutions in the long term.

In phase 1, a prototype for a specific set of documents (development documentation) was introduced and went live in August 2024.

The project is currently in phase 2, in which the old DMS, which primarily mapped SOPs and their reading comprehension, is being replaced. Template management and special topics relating to reading comprehension can now also be mapped.

After the planned go-live in 2025, further document types will be successively introduced.

The goal

The aim of the project to introduce a new document management system (DMS) is to completely replace and modernize all paper-based and simple electronically managed documents. This includes the migration of documents from the existing intranet, an outdated SOP management system and the previous system for reading comprehension. As part of the project, a central and modern DMS will be introduced, which will significantly improve the management, traceability and updating of documents.

The aim is to provide a standardized and user-friendly platform that facilitates access to documents, automates processes and ensures compliance with regulatory requirements. This new system should also ensure that documents are stored in an audit-proof manner and that work processes are made more efficient by reducing paper-based workflows and optimizing electronic document processes. The introduction of the DMS will ensure improved transparency, consistency and availability of documents, leading to increased productivity and greater adherence to compliance requirements.

Any questions about introducing a document management system?

What challenges can arise when introducing a document management system?

  • Onboarding process
  • Integration of employees without a PC workstation
  • Connection of subsidiaries and the field service
  • Requirements of the works council

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