Subject – Re-validating the clinical testing management system
Our client, a leader in Europe, is committed to supporting healthcare professionals by offering them up-to-date diagnostic tests and improving their services continuously. The company has over 15,000 employees, with its headquarters located in France.
With a focus on three key departments—Clinical Pathology, Genetics, and Histocytopathology—the client ensures comprehensive coverage across all medical specialties.
The client’s objective was to re-validate their clinical testing management system, comprising multiple modules. Following an audit deviation and the outcome of the periodic review, the client aimed to attain a verified state of the system, aligning with legal requirements and best practices.
In pursuit of this goal, the client sought consultants who could assist in the system validation process, serving as meticulous testers. After thorough discussions and confirmation of our expertise, the client chose to collaborate with eCValidation.
Scope – Re-validating the clinical testing management system
Our responsibilities included preparing test cases and conducting tests on the client’s internal system (classified as category 5 according to GAMP5).
Initially, we familiarized ourselves with the system by studying training materials and attending user training sessions. Upon gaining access to the system, we began learning how to use it.
During the learning phase to better acquaint ourselves with one of the modules, we received sample tasks (scenarios) from the client and tested them. Then, we started developing test cases based on the User Requirement Specification (URS) and Risk Analysis. Some requirements posed challenges in understanding their exact meaning and the author’s intentions. Consultations with users were conducted to clarify what needed to be included in the tests scope. Subsequently, we spent time determining the approach to test preparation and their desired format. During the test preparation phase and actual testing, errors in the URS and inaccuracies in approved requirements were discovered, some of which were addressed through deviation.
We divided the test scope among team members and prepared test scenarios accordingly. For some tests, suitable test data was prepared, but one of the challenges was the lack of appropriate test data for others, which posed difficulties in conducting those tests. Due to the complexity of the client’s processes, creating test data specifically for testing purposes was difficult, requiring additional time to search for them within the system.
Meetings with business users, previously prepared tests from previous years, and knowledge gained from training materials were helpful in test preparation.
Once the tests were ready, they were uploaded to the Veeva system and sent to the appropriate individuals for review. Upon receiving feedback, we made the necessary changes to the tests and resubmitted them for review.
Once the test scenarios were finally accepted in the Veeva system, they were uploaded to Azure DevOps. This marked the beginning of the final testing phase. All tests are conducted using the Azure DevOps system.
The client is heavily involved in the process, actively assisting us in resolving any encountered issues. They are responsible for the validation process in the project, while we are responsible for test development and execution.
We hold daily status meetings with the client on the Teams platform. During these meetings, we discuss progress and any issues encountered. Additionally, we convene separate meetings as needed to address ongoing concerns.
In our work, we utilize tools such as Azure DevOps and Veeva.
Results – Re-validating the clinical testing management system
In the project, three Professional Validation Specialists have been and continue to be involved. The client is highly satisfied with the team’s work. We received positive feedback from them regarding the prepared tests and our dedication. Furthermore, the client extended the order for another year, which serves as the strongest confirmation of their satisfaction. They are pleased with the individuals on our side participating in the project and expressed a desire to retain the same team.
The client valued our professionalism and dedication, as we actively identified and resolved issues while presenting various solution options. They expressed satisfaction with our expertise, skills, efficiency, and the outcomes achieved.
The tests conducted play one of the key roles in the revalidation process, allowing the client to fulfill both legal and quality requirements while maintaining the system in a validated state.
We have alleviated the client’s workload concerning test preparation and execution. Consequently, they will be able to address the deviation identified during the audit by successfully completing the validation process.
