Stacks of paper, what a hassle!
Staying on top of who printed what, where, and when is a common struggle for many life science companies. Document reconciliation is even more of a challenge. Printing may be unavoidable, but staying compliant and keeping that papertrail spotless is not.
Scilife has the answer!
We’ve created a brand new module, Print & Reconciliation, and it’s going to make paper a whole lot more manageable. In the webinar, CEO Filip Heitbrink discusses:
- How you can easily control printing from any existing application, directly within the module
- How to set up an approved printer network to print from anywhere while maintaining centralized control
- How scannable traceability barcodes speed up and automate reconciliation
- How to search and filter printouts
- The handy justified reprinting feature
- Your questions about the module
The webinar recording
The full recording can be accessed on the video below, together with expert answers to all the questions asked during the session, including those that Filip didn't have the time to answer live.
Q&A's from the sessions
1. Is a reprint allowed regarding data integrity?
Yes, As long as the reprint is logged with a reason, and you can show that that reprint has been issued, and why, and by whom. Then you have everything in place to provide proof why this reprint was necessary. We offer a solution to this data integrity issue by making sure that the Scilife system automatically identifies those reprints for you (and triggers a box in which a reason must be specified by the person printing) , without relying on the user to say they are doing a reprint. This way reprints are done in a controlled way.
2. If a batch record requests three printouts of a document, how can you do this? Do you need to reflect this in the form ID?
If you do a printout, you can just mention that you need three printouts. So the system logs it as three copies, instead of doing one print out and another one and another one. The system will consider those reprints and you would need to specify a reason. If you know that you need three printouts, then you can immediately specify the number of copies. In this case the system will not ask you why you're reprinting. It will log that there are three printouts because you initially required three printouts of that same form.
3. Is it possible to have a single barcode only on page 1 of a document instead of each page?
Not yet, but soon. This version of the module was created to solve the problem that specific pages were getting lost. However, now that we have been talking to companies that find scanning each and every page when they have thousands of pages too much work, we realise there’s a need for a ‘quick and dirty’ option too in the next version.
Generating one barcode for a whole document is less compliant, because individual pages could still get lost, but we will make it an option since it’s in demand. In this case it would be just one identifier and if you scan that barcode, the whole document is considered reconciled. However it wouldn’t allow you to reconcile specific pages.
In the next version of the module, you can configure it to page by page identification and barcodes, or just on document level and just generate one. You scan that barcode, it reconciles a whole document. If you group documents under a certain batch and you have a lot of documents, at least you know that one document is missing, not each page. It's a trade-off: efficiency over security. But, we listen to our clients so that will be configurable in the next version.
4. Is the system approved by 21 CFR Part 11?
Yes. The whole Scilife platform and all the modules are validated by us, according to GAMP5.
We do a full validation, exercise from VP to VR, with everything in between. It's a complete validation executed and signed off by us, which we offer as a prevalidation package to our customers. The whole system is built according to 21 CFR part 11, and validated according to GAMP5, because we're really focused on the life science sector; pharma, biotech and medical device companies are our main types of customers. Obviously these companies require a validated system. This validation package is done for every module, and every version of every module. Every time there is an upgrade, we update this validation documentation and you'll get access to it plenty of time before it goes live. That gives the customer time to do the last validation steps on their end, according to their intended use of the system. Effectively, our prevalidation takes away 95% of the validation effort for customers. We call it prevalidated rather than fully validated because you always need to do some last validation steps on your end according to that process.
5. What happens if a collaborator or an employee wants to do a printout of one page of the record and they don’t select the Scilife virtual printer? Can we prevent this and force use of the Print and Reconciliation module?
Everything that happens outside of the system is out of our control. The good thing is that if someone issues a printout outside of this controlled printing system, the printout itself will not have a barcode. If the printout does not have an identifier barcode on each page, then it’s not a valid print out. So it's visually possible to see what is a controlled print, or an uncontrolled print.
We cannot prevent the user from deciding to print unless you would not configure any printers except for the virtual printer, but that would be strange.
6. What if the user makes a copy of the printout in a copy machine?
That's also something that is very hard to avoid. However, there are copy-proof solutions out there. Firstly, you can only reconcile the document once. So if somebody makes a copy in a copy machine, you will have two copies with the same barcode; if you reconcile one, you cannot reconcile the other. You’ll know somebody copied the sheet of paper.
Of course, there is a situation where someone might copy a printout intentionally, to then destroy the first print out. They fill in the form and then they say, you know what, I’m going to fill it in again differently on my copy. There is no way we can avoid that.
However, what we did do for one of our customers, is to use a Void pantograph. A Void pantograph is a gray box, which we generate just like the barcode. So the application generates this gray box and it's a technology which when you print it the first time, you only see a gray box, but when you put it in the copy machine and issue a copy, then the gray box will display a message like ‘void’ or ‘copy’. It’s effectively copy-proof technology, something that visually shows that a page has been copied in the copy machine.
The drawback is that it needs quite some space because if we make it too small, it doesn't work. So one-page forms usually don’t have space for this.You can also use special ink, that when you put it in the copy machine it will change colour. There are solutions out there.
7. Can you issue a reprint from within the print and reconciliation module?
So even though the windows application generates this barcode and we place this overlay on each page, what the application does is then just send it off to the printer. But then it communicates back to Scilife: who did the printout, how many pages, what the barcodes are, timestamps , etc but it does not save the document itself.
So we do not store the content or the pages of the document. Therefore you can also not issue a reprint from within the printer reconciliation module. That's not what the module is for. If you need to issue a reprint, you need to go to the system where that document or form is sitting and you issue the reprint in the exact same way as you did the first time.
8. You talked about windows application, but what about Mac?
Pharma is probably the main interested sector in this solution and we noticed that Pharma sector is really Microsoft focused.
So we came out with this solution for windows only at this moment. For the next version, it's something that we have on our backlog. We will verify if it would be a blocking issue for a lot of interested companies to acquire this module because there is no Mac support. Then we will definitely add Mac support.
9. Can you somehow make it mandatory to print only through the print and reconciliation solution?
No, not really. If the user decides to not select the Scilife virtual printer there´s nothing we can do. However, the fact remains that the printout will not contain a barcode on each page, therefore, it´s not a controlled print. This will obviously be spotted during reconciliation because there won't be any barcodes to scan.
10. would it be possible to just have one barcode per document and only scan the first page to reconcile the whole document?
Currently this is not possible. However, after showing the solution to some specific companies we noticed that they would find it a too big effort to reconcile page by page. They found this solution too "heavy". So we decided to put on the roadmap the possibility to configure the system to only generate 1 barcode per document and show that same barcode on each page. This way you can reconcile the whole document by just scanning one of the pages of the document.
Of course it is less secure, but it will still allow you to track if all documents of a certain batch are still present. Just not up to the page level.
11. What if the user makes a copy of the printout in a copy machine?
This is an interesting question. It is very hard to close all the gaps that could happen in the physical world and this is one of them. We found a solution for this by using a technology that generates what they call a "pentograph" which is essentially a gray rectangle which consists of lines in a certain way. When you print the document, the pentograph will show up on the page as simply a gray box. However, if you make a copy in a copy machine the pentograph will reveal some characters in the gray box, for example "uncontrolled" or "copied". This way you can tell if the printout is the original one or a copy.
The drawback is that the pentograph rectangle cannot be too small for it to work properly. GxP forms are often designed to fit a lot of information on one page and there's often little space left for the barcode, let alone for an additional pentograph rectangle.
Other solutions that we have seen customers implement is using special ink in the printers that turns into another colour when you make a copy. But that solution is obviously unrelated to the Print & Reconciliation module.
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