Is it possible for a legacy number field to have a previous document number?
This is related to the document ID if you already have your own QMS in place, and you have an actual numbering rule or naming rule. What we do at the beginning is import the documents into Scilife and maintain your own naming rule.
Then we start building on top of that. We're not asking you to start from scratch, but instead helping you transition from one system to another. So you can use those legacy number fields. You could also decide to change them, both options are possible.
How do you get the data automatically in your document? Is that by including field codes in the template?
We have variables, and these variables are available for you. You copy-paste them into your template, where you want Scilife to fill in the values. Then, when you create the document, Scilife uploads a copy of the template with the variables in the right place.
Does the eQMS support other languages besides English?
So far, it is available in Dutch, Spanish, and French. We are working in other languages that will come later on. But yes, we're working on that.
This works at the user level, so every user can have their own language choice.
How about language settings - are you looking to have dual language settings for any document?
The content of the document is completely up to you. What we're going to change is the layout of the application with the different languages. And this, again is at at user level.
Will there be a history for the flow of review?
Yes, there is a version history, so you can see every version of that document and every change made to it.
You can also check in the audit trail, where you can see whenever someone does something in the document: signatures, status, dates... So you can have complete control over this flow.
Is every document assigned with a Periodic review? And how is the Periodic review due date calculated?
You define that at the document type level. If you don't want a document to have a certain revision, you can establish that, so it's not mandatory to review. And then, based on your policies on the regulation, you can define this timeline for every document type.
In terms of how the periodic review date is calculated, whenever you set a document to "published", then we apply that timer. So if you set 24 months, it's going to be 24 months from the moment that you effectively publish the document.
Where can I find the variables?
The variables can be found when you're defining the document types. You will have an option there to see the different variables, and you'll have them all listed. You also have the option to copy them and then you just paste them into the template.
You can also upload a document template with all the variables that you have chosen, and save that document type to then start creating documents under a certain type.
Is the effective date of the SOP the same as the last approval date?
No, the last approval date is when the last role signs it. Then the document can have a training period (approved, not published status) after which the document can be published. This will establish the effective date.
What do you take into consideration for the average hours for Events in the ROI calculator? Event creation, RC Analysis, Reporting, Event responses prep and CAPA creation, CAPA resolution, KPIs, CAPA effect. check
Event creation, root-cause analysis, reporting, event response preparation, CAPA creation, CAPA resolution, KPIs, and CAPA effectiveness check.
How flexible are Scilife's document control workflows? Can you set a sequence for several reviewers to sign?
Very flexible! You can configure it so that reviewers sign in a certain sequence if they should do it in parallel or even if only the first one signing pushes the document to the next workflow status.
You mentioned one challenge when reducing the cost of quality is securing data integrity. For us securing the data integrity of printed documents is a very heavy burden. How can you reduce this effort/cost?
Well this can be solved with Scilife's Print & Reconciliation solution. A tool developed specifically to maintain the data integrity of printed documents. You can track printing activities and the whole reconciliation process after their use.
How can KPIs help you reduce quality costs?
A: Our new KPIs module gives you different insights on a preventive level, allowing for a reduction of the 'Cost of Poor Quality.'
