Our consultants Sofie and Thomas have been working on the implementation of electronic batch records for one of our customers over the past year. Also curious about their experiences? You can find out more below!
What was your role within the project?
Thomas: I was part of the project team as QA responsible. Within this role, I was involved in the discussions about how we would design the system, up until the final documentation of these approaches in procedures and work instructions.
Sofie: I took on the role of technical writer in which I supported the creation of the necessary procedures, as well as the theoretical and practical training of the end users.
What were your main challenges?
Thomas: As it concerns a multi-use plant, both experimental and clinical batches can be manufactured within the facility. The main challenge for us as QA department was to maintain the balance between the flexibility that is needed for experimental batches, and the compliance level required for clinical batches. We therefore performed an end-to-end risk analysis for manufacturing of clinical batches within the system to ensure that all compliance requirements were captured and addressed in a pro-active and structural approach.
Sofie: Relating to documentation, I think the main challenge was in the early phase to motivate and guide all authors and management to dedicate time on getting to know the system, to discuss concepts and to start drafting. As with all new things, the beginning is always the hardest. In a later phase, we organized review sessions in group so that comments could be addressed with all parties involved right away.
What did you learn during the project?
Thomas: One of the great opportunities I received during this project, was to follow a training from the supplier of the MES system. During this training, I was able to learn a lot about the system and take a deep dive in the way the software has been designed.
Sofie: I gained a lot of knowledge on the software itself and the creative ways in which it is applied in the plant to be in compliance with clinical requirements while maintaining flexibility for the scientists.
Meanwhile, the first batches have been manufactured with a full electronic batch record. Thumbs up for the great collaboration with the project team from Janssen.
Feel free to contact us to discuss how we could support your company in digitalizing your batch record system!