When managing documents, is there any way to compare different versions? Also, with records and documents, how long does the software maintain old versions?
Yes, Scilife's document management system allows version comparison. It maintains a history of versions, including minor ones. Versions can be viewed, downloaded, and compared. Scilife complies with 21 CFR 11, retaining electronic records indefinitely, even after deletion (deleted items), accessible with a full history and audit trail.
Can you requalify a supplier if needed?
Certainly, Scilife enables supplier requalification. The system supports requalification processes and deciding on necessary audits.
How does Scilife manage employee competencies? Are they pre-filled?
Employee competencies aren't pre-filled. Managers define them and categorize them, and employees update their CVs and competencies for approval. Scilife integrates with training for ongoing competency maintenance.
Can existing competency data be transferred to Scilife?
Yes, during onboarding, we assist in migrating competency data and other relevant information from Excel spreadsheets to Scilife. This includes records and equipment.
Can a read-only user start a deviation?
No, read-only users cannot initiate deviations. They can engage in training, tasks, and competency updates. Deviation initiation requires appropriate user access, but read-only users can report deviations to their managers (who could be full users who can log the deviation).
I have seen there are more training materials than just the preventive maintenance procedure. Does this system force you to retrain people in all the different materials when you update this procedure, or can you just ask for retraining in the procedure in particular?
No, retraining when there is an updated document is only for that particular document. The retraining for the whole training is configured at the training level, and you can set it up for the recurrency you require. Nevertheless, if there are documents in that training that have already been signed off in another training or because of an update within that period, trainees do not need to sign them again until it is the right time.
When performing a Risk Assessment and specifically revising risks, what is the main benefit of using this tool over doing so in Excel?
In my opinion, at the revision stage, the greatest benefit over Excel is the capability of selecting the risk mitigation actions and assigning them directly to a CAPA (existing one or new one).
Can we evaluate suppliers using Scilife?
Absolutely, with our Supplier Management tool.
What happens if an employer is sick for a longer time and can't sign the training/SOP? Will this document not be active until this person signs?
No, there is a manual trigger for QA to effectively publish the document once it has been approved, regardless of the completion of the training. This functionality is precisely to prevent this situation.
How do we identify recurring deviations?
A way of tracking recurring deviations is using the Events list page and filtering by event type (deviation), cause, impact, tag, product/service/project, client/vendor/contact. Another way to do it is with Scilife’s KPI tool, which is also a clever way of monitoring it.
Can a log be created for all deviations/CAPAs?
Sure thing! Each deviation will be logged and can be retrieved from the Events listing page. The same happens with CAPAs (CAPA listing page). When a deviation or a CAPA is logged, it will require an FDA 21 CFR 11 / EU Annex 11 electronic signature.
