Do you need a plug-in for electronic signatures or external software?
No, electronic signatures in Scilife do not require any integration or plug-in; it’s a 21 CFR part 11 compliant signature that is enabled within the system. There is no limit on how many times you can sign. It’s an out-of-the-box and validated functionality that is ready to use.
What advantage do you see in live editing documents instead of downloading them and working locally?
Live editing documents is very important because it ensures traceability and data integrity. If you download the document and work in your local environment, you can never assure that no one else has been touching and editing it, or that someone is not working on the latest version of the document.
By live editing the document, you guarantee complete traceability as it stays within the system, and every change is logged. Also, another feature we didn’t mention previously is that there is a lock associated with the live edit tool. This means that if one specific user is editing the document and another user tries to edit it at the same time, the document will appear as locked. This guarantees that no user can simultaneously overwrite anything that another user is modifying.
How do you ensure that the right people see the right documents?
In Scilife, there are two mechanisms to control this. We have the permission roles that determine what people can do, whether they can only see documents or also be authors, and so on.
But another important feature for this purpose is the groups. Each group determines who has access to which documents, training, CAPAs, etc. Additionally, users who don't have access to a group can't edit, change, or even view anything that is restricted to that group, if they don't have access to that group.
Scilife’s system is built in a way that you can easily define who can access what and who can’t.
How easy is it for the reviewers to add comments?
If, once you sign a document, you want to push it back for review, you can add a reason, and this reason is saved in the audit trail and sent by email to the author of the document.
But you can also add comments to any document, and you would be able to see the role of the person who added the comment, on which version of the document, the date, and the comment itself. These comments are also tracked within the audit trail.
How are tracked changes handled?
Every time you save a change, it generates a minor version of the document, so you have access to all of the versions and can download and compare them.
But there are many other ways you can track the changes made in a document:
- You can activate the tracked changes functionality in the live edit Word document, so you can see the changes made by different people editing the document.
- You can use the comments to suggest changes or to document what you have changed.
- Another option is to add a “history” section in the document, where each person who edits it can type in the specific changes they have added to the document.
Can you explain a bit about the backup of the Scilife system? How can we restore documents in case of an incident?
This article explains how data is backed up in Scilife: https://www.scilife.io/security
Are there 21 CFR part 11 and EU annex 11 certificates or statements available somewhere?
Compliance with 21 CFR Part 11 and EU Annex 1 is demonstrated through the validation process. This process involves mapping user requirements with existing features, testing them, and creating a Validation Summary Report to declare that the system is validated as per the specified requirements, in line with 21 CFR PArt 11 and EU Annex 11
Does the turnaround time reset if the reviewer sends the SOP back to the authors?
Yes, if a reviewer sends the SOP back to the authors for revisions, the turnaround time will reset. This is because the document is returned to the draft status and needs to go through the review process again once the revisions are made. The system will track the time from when the document is resubmitted for review until it is approved again
Do you have to wait until everyone has signed for the R&U of the document, or can you also set a fixed period after which a document goes live automatically?
No, Scilife does not enforce a mandatory "read and understood" signature before a document can be published. There is a fixed time period set in Document Control. However, it is important to establish your internal processes and ensure that all relevant individuals have reviewed and understood the document before it is published. The responsibility lies with the organization to ensure compliance with their internal procedures and regulatory requirements.
Do you need a license to sign a document, or is it possible to send a document to a customer to sign without them having full access to Scilife for instance?
A license is needed to access and use Scilife. Signatures require a full license.
How does the audit trail cover all the events?
Every time you register an event, Scilife will generate a unique and unmodifiable audit trail that will log everything that happens.
Is it possible to prevent the same person from creating and approving the document?
Yes, you can apply restrictions at the procedural level.
How can we access the audit trail for a document?
Every document change is recorded in the audit trail: creation, edition, rejection, status change, etc. You can access the audit trail by going to Documents>Documents, using the Filters and/or Search Field to find the document where you would like to see the Audit Trail, and clicking on the document you are looking for. In the Document Details Page, you can go to the Audit Trail Tab, and there you will be able to see the entire history of the Document in 5 columns: Activity, User, Email, whether the activity was signed off electronically or not, and the Date the Activity took place.
