About Me
My name is Steven, and I joined Normec Advipro in April 2022 to work on my first project as a Project Asset Specialist at MSD Oss. In this role, I joined MSD’s project team to work on the development and improvement of their existing production facilities. The project structure provides a clear starting point and end goal, and in my view, it’s a great opportunity to gain experience with all the steps of the qualification process according to the V-model.
V-Model
So far, I’ve mainly focused on designing and drafting the documentation (the left side of the V-model). Recently, I’ve started working on the implementation phase (the right side of the V-model). During this work, I’ve had a lot of contact with various departments, external parties, and “eVal,” MSD’s new paperless validation tool.
Paperless validation—what’s that?
I’d like to briefly explain exactly what paperless validation entails.
There isn’t much difference from the paper-based method. The same documents are still created, and this documentation still needs to be drafted and approved. To clarify the differences, I’d like to use the workflow of a qualification protocol as an example. This is a protocol that describes how we will demonstrate/test that the equipment or process meets the requirements set out in the URS (User Requirement Specification). Such a protocol contains multiple test plans that, once executed, demonstrate that the equipment or process meets the URS requirements. Previously, the workflow was as follows:
- Drafting the qualification protocol
- Reviewing the qualification protocol
- Printing for pre-execution approval
- Archiving and copying the entire document for execution
- Conducting tests on the copy and adding attachments
- Review of the executed test protocol
- Post-execution approval and archiving
These steps resulted in a lot of paperwork and thick folders where, in my opinion, it’s easy to lose track of things. With paperless validation, all steps are carried out digitally. This means that, in practice, everything can be done digitally within the same file. However, it must be clearly indicated who did what and when—in other words, everything must be documented according to the ALCOA+ principle. This cannot be done using a standard Word document; therefore, a specialized environment is used for this purpose. In my environment, this was “eVal,” a software package from Kneat. In this environment, everything is documented according to the ALCOA+ standard while tests are being conducted. Every change you make is dated, and the system continuously tracks who adds information.
Challenges
Despite these major advantages, there are also some interesting challenges. I’ve briefly encountered the following:
- Adding raw data to protocols now requires a TRUE Copy procedure.
- You can only make a quick note in areas that have been designated for that purpose in advance.
- A laptop or tablet is required to fill out the protocols. (This may not be possible in every environment.)
- Both the “Performer” and the “Witness” need their own laptop or tablet.
These challenges lead to many interesting discussions with the various departments. During these discussions, it’s rewarding to see that we’re shaping the standard working methods and protocols of the future together. In my opinion, this shows that paperless validation is still very much in its infancy; development is still in full swing. For me, this creates a motivating work environment where I can quickly absorb a lot of knowledge. I’m very curious to see where the future will take us in this area.
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