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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