Is it possible to link forms, templates. etc to the SOP or WI procedures?
Yes, using Scilife Document Control solution, you can link an SOP with their WIs and templates. All documents can be integrated in the same platform with a click of a button.
Where is it possible to find more information on how to create templates for different types of documents (SOP, WI, URS, etc.) and how can these be linked with associated forms, etc.?
In Scilife you can create ‘Document Types’ which will not only define the template you want to be used to create certain documents, but also many other metadata that is also relevant, like revision periodicity, access permission, etc.
SOP’s, WI’s and other types can then be easily linked to other documents or forms, whether you do that through a ‘parent-child’ relationship or just a simple link.
How many document numbering structures can be defined (based on a type of document)? Is it possible to define a separate document ID structure for executed IQ, OQ, PQ, etc.?
There is no limit. You can define as many different document types, and at the same time as many prefixes (based on which Scilife will generate the unique ID of documents) as you need.
Is it recommended from Scilife what margins should be defined to use a secure printout of the barcode?
The amount of space required depends on the metadata to be configured, and the barcode can be moved around the page to find a suitable place. Scilife can help assess the amount of space required, but it is also possible to calculate and leave margins.
If you can print to PDF, can you reprint from there without reconciliation?
Only approved printers are authorized to print through the Scilife Print and Reconciliation solution. In a real environment, you should only approve a printer that cannot be tampered with. It is also necessary to ensure that the printer does not have a temporary folder that allows printing from the temporary.
Can you assign the barcode on a scanned document?, for example, when uploading a legacy document to the system?
If the document is in digital form, the barcode can be added when printing. You can upload the document to the document control system and print it in a controlled manner using the print and reconciliation solution. The system will provide a unique barcode for any document printed.
There are multiple guidance published by different regulatory bodies. Which guidance is ideal to ensure data integrity requirements?
21 CFR Part 11, Annex 11 and Data Integrity regulations by FDA and MHRA, WHO, etc. are very useful to understand the requirements.
Can it be a barcode structure like: Document ID+ page number? Is it possible to define a structure of the barcode?
You can define all the necessary metadata, but the barcode will be assigned automatically and cannot be changed.
What is the process same in case Microsoft Office is not used by an organization? I guess in this case you have to download the document and work on it offline and then re-upload it. What happens with tracking in this case?
From the document control perspective, you can use any text editor that you like. The added benefit from using Office is that you have automated variables and the possibility to edit from within Scilife using MS Office. You are right in the assumption that you would need to download, work locally and then upload it again if you are not using MS Office. The rest of Scilife functionality is exactly the same when it comes to going through the approval workflow, electronic signatures, version control and audit trail.
Can we integrate the Scilife system to an ERP system, for example, Business Central by Microsoft? Meaning that if a document has been updated like IFU then the latest version of the document will be auto linked and updated to the ERP system?
Yes, it is possible to integrate Scilife to an ERP system as we have an API. And that is what you would do for the purpose you mention. However, for the specific Print and Reconciliation solution, you do not need to do it, as you can print from any source without any integration.
