Digital entries are made directly. Can this be used to document raw data as well? What if the data entry is changed before the record is finally signed? Will this be tracked in the audit trail?
Let's have a look at how these forms actually look within the system. A few days ago I was setting up a form together with a customer for a temperature record, and what he essentially needed to do was upload different PDFs, with all these temperature entries. How did we do it? We simply set up a file field where he could upload the different files that were needed, and then those got stored within the record itself.
With respect to the versions, you can go to the versions tab, and you'll see that for every entry that you have on a record, you will always be able to retrieve it, go back and see all the different entries that were there along the way.
Also, while the record is in draft you are still able to edit it. So when is it finally sealed, so to speak? When can’t it be edited anymore? To achieve that, you would need to move it forward and set it under signing by QA.
Can a record be printed?
We've seen that with Record Management you can prepare a form and print it. The important part is that, according to Data Integrity, whenever you print a document, this printing should be controlled, and afterwards reconciled. In Scilife we have the Print & Reconciliation solution that allows you to comply with these print and reconciliation requirements.
We would love to show you how it works in a separate Deep Dive, as we won’t have time to do it today. But essentially you would download the record from Record Management as a PDF.
In order to download it with a certain layout, you need to configure a template in the document control tool, also available in Scilife. You can give it any design that you'd like, with a header of the company, your logos… so that when you download the document, if you need to share it with external parties or print it, it will have the layout that you would wish for.
Once you have the template, when selecting “download as a PDF”, you will see a drop down menu with multiple options. You can select your template from here, and download it with the desired format.
