When reviewing a document where in the system can I justify that the change to the doc is not significant and other rationals? This is when a Change Request is not required.
Whenever you have a published document, when you force a review as you sign, you can give a rationale in the “Reason” field. This would probably be the best place. You can indicate the reason for the force review. It doesn’t require a change request because it’s low-impact, so you can avoid going through that process. However, this would also be captured in the audit trail.
Are you able to edit the documents in other programs like Pages (mac) and Google docs?
The integration that we have is with Microsoft Office 365, so if you want to use the “live edit” functionality that I showed during the demo, you need to have Microsoft Office. If you want to work with any other tool, that is perfectly fine, you can download the document, work locally and upload the document again.
Can you revise a document offline? Or does every revision have to be done directly on the cloud version?
This is a web-based system, so you have to work online. Of course, you can download the document, work locally and upload it again at your convenience. But if you want to maintain full traceability, you would need to work online.
Could you please comment on how Scilife complies with software validation requirements?
We are following the GAMP5 standard. Apart from that, we cover almost 95% of validation efforts, we give you a whole package of validation, and the remaining 5% is what you need to cover according to your requirements. This is to make sure that the system is fit for your purpose.
Is it possible to add more than 1 custom field? What is the max number you can add?
There is no limit on custom fields, you can add as many as you need.
If necessary, for a given CAPA, how do you track the effectiveness of a specific corrective action?
You have an effectiveness check status in the workflow, so you can do an effectiveness check if you consider it necessary. It is not mandatory. This is more of a general one, after everything is signed.
If you want to do it on a specific action, you would then create another action, which would be “Effectiveness check of X specific action”.
Is it possible to integrate and link SOPs with other processes?
Absolutely! You can link documents to other documents, you can also link events to documents… so you can link SOPs with a specific complaint, for example, without any trouble.
How do you manage the download option for ‘documents edit’ if two people have downloaded the same document? Could it be the case that information is lost if two people upload versions?
That is of course the danger of working locally. You can enable a setting where you can establish that documents can not be downloaded. There is also a lock in the live edit functionality, so if anyone else has started editing the document and they try to upload or modify the document, they won’t be able to do so.
However, if you have two authors and each uploads a new version of the document without moving it in the workflow, the last version uploaded will take precedence. Despite this, you will retain a complete record of all uploaded versions, along with information about the authors, users, and timestamps.
