Paperless validation, (im)possible?
- Steven Van Duijnhoven
- Project Engineer
In this blog, Steven takes you into a world of paperless validation. Find out here what exactly it entails and how you can apply it in reality. Steven shares his experiences and explains the challenges and developments of this new method.
Over mezelf
My name is Steven and I joined Advipro in April 2022 with my first project as Project Asset Specialist at MSD Oss. In this role, I joined MSD's project team to work on the development and improvements of the existing production facilities. Due to the project structure, there is a nice starting and ending point and, in my view, a great opportunity to get involved in all steps of qualification according to the V-model.
V - model
Until now, I have been mainly concerned with designing and drafting the documentation (the left side of the V model). Recently, I started working on implementation (the right side of the V-model).
During this work, I have had a lot of contact with various departments, external parties and the paperless validation tool "eVal", which is new for MSD.
Paperless validation, say what?
Let me briefly explain exactly what paperless validation means.
There is not much difference from the paper method. The same documents are still created and this documentation still needs to be prepared and approved. To make the differences clear, I would like to use the workflow of a qualification protocol. This is a protocol that describes how we are going to prove/test that the equipment/process meets the requirements drawn up in the URS (User Requirement Specification). Such a protocol contains several test plans that, after execution, prove that the equipment or process meets the URS requirements.
Previously, it involved the following workflow:
- Drafting a qualification protocol
- Reviewing qualification protocol
- Printing out for Pre-execution approval
- Archiving, and copying the entire document for execution
- Run tests mentioned on copy and add attachments
- Review of executed test protocol
- Post-execution approval and archiving
These steps created the necessary paperwork and thick folders that, in my opinion, you quickly lose track of. With paperless validation, all steps are performed digitally. This means that, in practice, everything can be done digitally in the same file. However, who did what and when, or in other words everything must be ALCOA+ documented. This cannot be done with your standard Word document, so there is a special environment in which this is done. For my environment, this was "eVal" a software package from Kneat. In this environment, while running tests, everything is ALCOA+ documented. Everything you change is dated. There is always a record of who adds information.
Challenges
Despite these great advantages, there are also interesting challenges. Briefly, I have come across the following:
- Adding raw data to protocols now requires a TRUE Copy procedure.
- Making a quick note can only be done in places previously created for this purpose.
- Laptop/tablet is necessary for completing protocols. (This will not be possible in every environment)
- Both "Performer" and "Witness" need their own laptop/tablet.
These challenges create many interesting discussions with the various departments. Within these discussions, it is nice to see that you are shaping the standard working methods/protocols of the future together. From this, in my opinion, you can see that paperless validation is still really in its infancy, the development is still in full swing. For me, this creates a motivating working environment where I can quickly absorb a lot of knowledge. I am very curious to see where the future will take us in this area.
Auteur
