Is there a way to guarantee data integrity with Scilife?
Absolutely. Scilife offers multiple mechanisms for maintaining data integrity. Firstly, there's the audit trail feature, which tracks every process step. Additionally, changes are meticulously logged, providing full traceability of all actions within Scilife. Furthermore, the versions tab allows users to easily access and review different versions of data. These features not only track changes but also record all edits made. Moreover, users have the option to download the entire dataset in a spreadsheet format for comprehensive analysis and review.
Is it possible to integrate and link SOPs with other processes?
Yes, absolutely. With the Document Creation form, you can link various documents related to the quality manual, including SOPs or Work Instructions. Additionally, you can link a parent document if applicable and set up a periodic review schedule.
For example, if you need to review a document every 12 months, you can configure that directly within the Document Creation form, along with setting up notifications. All linked documents can be conveniently viewed in the "Linked Documents" tab.
Does the Change Control have an effectiveness check?
Yes, it does. Each change request comes with a workflow accessible through the "More" button located at the top of the change request. Within this workflow, you can approve the implementation of tasks associated with the change request. Once all tasks are completed and approved by QA, an effectiveness check can be conducted for the change request. If these steps aren't necessary, you have the flexibility to bypass QA approval and proceed directly to closure.
Is Scilife 21 CFR Part 11 compliant?
Yes, absolutely, Scilife is FDA 21 CFR Part 11 compliant in terms of electronic signatures and records. It has also been fully validated according to GAMP5.
Does Scilife provide Change Control tracking notifications and dashboard reporting? From the QMS owner's perspective as well as grom Supplier/Service provider's perspective?
Scilife's Change Control allows for tracking and notifications. Notifications are received via email and dashboard too. If that is not enough, you also have a KPI module, in which you may analyze a full set of useful reports for Change Control.
How does Scilife adapt to user-specific workflows, such as addressing temporary planned deviations in the change control process?
While Change Control comes with a standard form and workflow, Scilife offers flexibility through the 'Events' module. This module allows users to customize the information captured during the registration and investigation of events, such as temporary planned deviations. Users can configure the system differently for various types of quality events. Moreover, Scilife enables linking items across different modules, facilitating the registration of unplanned deviations tailored to specific needs. Subsequently, users can seamlessly follow up with CAPAs and integrate them into the Change Control process as necessary.
Can multiple people be assigned to work on the same document simultaneously? Does it have revision or version control?
Multiple people can be assigned to work on a document. However, only one can work on it at a time. When one person is working on it, the document is locked so the others will not be able to work on it simultaneously. This is so that edits and changes can be effectively tracked to achieve a high level of traceability and data integrity. Version control is automatically maintained.
Are versioning rules within Scilife customizable by the User?
No they are not, versioning is handled automatically by Scilife.
Does this document open a separate Word file or do we have to work on the Scilife platform?
The document will open up in your Microsoft Word application as a temporary file for editing, and will automatically upload back onto the platform to be viewed once saved and closed.
Can you have a document that does not show the names, as you may have multiple reviewed, and just refer back to the change request instead?
Yes, you can configure your templates so that the names do not show on the document.
Can we link training SOPs to the same platform and link them with Change Request or CAPA as deliverables?
Yes, you could create new or upload existing SOPs to the platform in the doc control tool. From there, you can link them to anything in the platform - Trainings, Change Request, CAPAs, etc. You can also specify SOPs as deliverables in a CAPA or Change Request plan.
Can dates be presented in international format (e.g., dd-MMM-yyyy)?
Yes, this format can be configured in the general setting of Scilife.
Can you create a Design Traceability Matrix? And integrate it with risk management?
This will be in the scope of the new Design & Development module that will be released very soon.
Is the change request form a default form created within Scilife or do you need to create it personally?
It is an off-the-shelf form that you already have in Scilife, you don't need to create it. The same applies to the CC workflow.
How often do you need to change your password? Is there a default time or can you set a time period?
You can set the time period for this in the general settings in Scilife.
I'm guessing Scilife can handle multiple global sites with different needs, training demands, etc.?
Yes, Scilife can handle multiple global sites. There are different ways to manage this, for example via groups, tags, etc.
