Project set in 2009/10, it seems to talk about the Paleolithic, probably when we talk about IT we should change the unit of measurement from years to n*10, otherwise the younger generations will not understand what it meant to apply technology in production environments even 20 years ago.
THE COMMANDMENTS:
- All paperless
- All web
- All Part11 compliant
The goal that we have set for ourselves is to make as many of our projects as possible paperless. Unfortunately, the main constraint is that the software has to be designed and used in compliance with CFR21 Part 11 in order to store and use information only in electronic form in the pharmaceutical/biomedical environment.
After careful analysis, we understood that it is common practice to share login credentials. Almost always, both are written in a very secret place... under the keyboard. As a result, we need to find a solution that is both practical and ethically correct.
After several studies, we found the solution in a physical token (Vasco). We bought one for each person who needed to sign a document.
Once that was done, we convinced ourselves that the bulk of the work was done... then we thought about it and realised that this was not the case.
The IT system was absolutely On Prem, the cloud is going to come in about fifteen years, the technologies, as you can see in the video where I'm presenting the project to management, are based on developing client server applications, but we want to go further. We want all our systems to be paperless and web-based.
We are absolutely convinced that developing client-server applications would be much easier and cheaper. But it would not last long.
So we thought about how we could create something that would digitally sign documents, but also record web applications. This would allow us to validate the system in accordance with FDA regulations.
We started with the management of the physical token, which had to be associated with a user with a relative PIN. The activation alone was not trivial, not so much for the technological part, but because it will be necessary to sign a document in which the user of the non-repudiation of the signed record/document.
Once again, it's not an easy thing to do today, let alone in 2010.
Each paper document signed by each user had to be archived electronically, of course (let's remember the first mandate). So Alfresco was implemented, a system that seems incredibly flexible to us, but above all free, let's not forget that we're in 2011.
But as always, free does not mean easy. The system is anything but easy.
We have finally completed the installation of the document and what promises to be a great workflow processor. We need this last object because the famous DHR, a sort of "booklet" that follows each single batch, in our case more than 25,000 per year, as it progresses through the production chain, the DHR is enriched with information that must all be signed and countersigned; this is the reason for the workflow.
In reality, we will not be using this utility for DHRs, but only for other documents such as RDAs or any documents that have undergone a complex authorisation process, as anyone with the patience to read the whole document will understand.
At this point, it's necessary to create a system that prepares the USB tokens, which must be indelibly written with the information that we have identified as mandatory (personal ID and name, surname and user in AD), plus all the management of the PIN, in accordance with the procedure, this must necessarily be changed every few days. Then it's necessary to understand how to manage the tokens that are lost and therefore replaced, as well as the tokens of people who decide to leave the company.
Finally, let's complete this task.
Now, in order to digitally sign the document or record, we need to think about how to create and manage asymmetric keys system
So we continue to develop the part that will manage all the tokens in the ADMIN part of our solution. Obviously there will be token number 0, which we will use to create token 1 (mine) once it has been created. It will then be destroyed so that no one will be able to tamper with the electronically signed records.
This would be enough to make it clear how complicated THE project was, today we would call it DIGITAL TWIN, in reality I only realise now, as I write this post, how much we were precursors of what is considered NORMAL today (with special care not to praise ourselves too much .... as those who praise themselves...yes...), for those interested in knowing the next steps, I ask you to be patient .... in the meantime you can laugh while watching the video I link to below.
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