For the past three years, Blandine has worked with Septodont, one of our customers, as a computerized systems validation officer. At the heart of demanding projects, she has contributed to securing, structuring and optimizing computerized environments essential to their activities.
In this interview, she looks back on her experience, the challenges she faced, the skills she mobilized and what she gained from this long assignment.
Could you describe your role within the company you have supported?
“At Septodont, I was in charge of validating computerized systems as part of a small team. My role consisted mainly of validating software during implementation and acting as an active member of project teams.
I was also responsible for maintaining systems already in routine use in a validated state, which involved quality management of changes as well as carrying out periodic reviews to guarantee the conformity of tools in their operational environment.”
What was the initial context at the start of the computerized systems validation mission?
“My mission was to support the computerized systems validation manager in the validation of new tools. I first worked on small systems used in R&D and production, before taking charge of more substantial projects, notably around SAP (ERP). “
What was the problem you were trying to solve?
“In each project, my aim was to find the right balance: to implement a validation that was thorough enough to control the system and guarantee its use in compliance with regulations, while optimizing the processes so as not to mobilize too much time or resources.
In this way, I ensured that the software met regulatory requirements and user needs, while remaining efficient and proportionate in terms of effort, workload and deadlines.“
What were the main objectives of this validation mission?
“Alongside computerized systems validation projects, I also carried out routine optimization work. This included the creation of templates as well as a regulatory watch to ensure that the customer’s practices remained compliant and consistent.
With regard to validation activities (VSI), there were two types of intervention:
– Routine work to manage small changes,
– And project mode operation for major upgrades or the implementation of new systems.“
What results were you expecting?–at start-up?
“The aim of my validation mission is to have a computerized system that meets user needs and regulations, and can therefore be used by users.”
What were the mission’s major milestones?
“After a project definition phase, which served to define the system’s use, a criticality analysis was carried out to determine the validation strategy, detailed in the validation plan. In the design phase, the risk analysis was drawn up on the basis of the system’s functional and technical specifications.
The risk analysis was used to draw up the test sheets required to put the system under control: installation (QI), data recovery (QM), operational (QO), performance (QP). On completion of the various phases, a report is issued authorizing use of the system in a production environment.
During the hypercare phase, modifications were managed under change control (CC). A final report concludes all validation activities.”
What were the most decisive regulatory factors?
“The most decisive regulatory elements were mainly based on the Good Practices (BPx) framed by the ANSM and the GxP guidelines framed by the EMA, as well as the requirements of 21 CFR Parts 210, 211 and 11 issued by the US FDA. In addition to these frameworks, there are standards specific to medical devices, notably ISO 13485 for quality management systems, and the requirements of 21 CFR Parts 280 issued by the US FDA. Finally, Data Integrity guidelines, in particular those issued by the MHRA, were also crucial to the project. “
Did you encounter any difficulties and how did you overcome them?
“One of the main difficulties we faced was understanding the computerized system in its target user environment, which is essential if we are to correctly identify risks and design truly relevant tests. This requires fluid communication with the business teams, who are not experts in validation and need to be challenged to obtain the necessary information.
In fact, an ERP is a cross-functional system. It is the collaborative work between the business and the VSI that provides the level of information required for a pertinent risk analysis.
To overcome these difficulties, two actions have been implemented:
– Make business experts aware of the challenges and requirements of computerized system validation, so that they understand the expectations and importance of sharing the right information.
– Organize dedicated work sessions for the VSI team to deepen knowledge of business processes and place the system in its operational context.
These steps have improved collaboration, enabled us to better identify risks, and ensure more efficient and appropriate validation.“
What concrete results did you achieve thanks to the mission?
“At the end of this mission, SAP was deployed and used within the customer’s company. This teamwork enabled the customer to adopt a mastered and operational tool. “
What has been the feedback from internal teams following the implementation of validation?
“For some key users who were confronted with validation for the first time, it gave them a better understanding of practices. The system validation phase also gave them real confidence in SAP’s ability to meet their needs and support their day-to-day activities. “
How would you sum up the overall impact of this mission?
“Working on a system as cross-functional as SAP enabled me to understand all the company’s business flows, from purchasing and planning to quality, production, sales and logistics. As a result, I was able to significantly increase my skills by discovering how all these processes fit together.
Taking part in such a large-scale project, deployed over two years, also gave me a concrete insight into the challenges of a major ERP project. It was a real opportunity for me to be integrated into the customer’s VSI team, not to work alone, and to contribute to a large-scale, strategic project.
To sum up, this assignment was a rich, cross-disciplinary, formative experience that strengthened my skills and broadened my understanding of systems and businesses.“
