Is there a checklist in Scilife included for every process to be audited?
Our experience shows that every customer needs some specific items in their checklists that are different from those of other customers, which means there are always some variations between them. You can create these checklists within the Document Control tool, or alternatively within the Records tool. Once you have created the checklists,, you can link the documents and the record to the audit.. This is a way to customize the checklist and link it back to the audit.
Is it useful to use the audit module for external audits if the host does not work with Scilife?
Definitely. There's a section where you can add the email and name of the host that you have at the external party. Most of our customers make use of the external audit as well, because this enables you to document the whole process. The steps would be the following:
Once you finalize your audit, you must share your report with your supplier. And at some point, they should get back to you with their report, including their mitigation actions that you will have to read through. The advantage of having everything within Scilife and within the Audits tool is that you can upload that documentation, anything that you get back from your supplier, into the file step of the audit, leaving everything nicely organized in one place for anyone to retrieve at any point in time.
You have the whole section where you log your own findings, as well as all the documentation that you receive from the supplier with their mitigation plan. And, to make the process even better, you have the option of linking it back to your supplier qualification using the Supplier Management tool.
If you would like to dive a little deeper into this topic, I would recommend watching the videos on external audits in the Scilife Academy.
How do you create audit document types in Scilife? Is there a type for all audit documents, followed by creating specific documents for each audit?
You can create and define your own document types (Standard Operating Procedure, Work Instruction, Validation Protocol, Audit Agenda, Audit Report, etc.). You can also establish a document prefix which will be automatically included when generating the document ID (SOP-, WI-, VP-, AA-, AR-, etc.).
To create these document types you need to go to Documents, click on Document type, and then on the “New+” button. You will find more information about the topic in this article from our Knowledge Base.
What is the meaning of the tags? What are they used for?
Tags are labels present in all item creation forms that help to organize data in Scilife. Tags are also used to link different items to each other, filter, and search for items more easily.
