EMEA Office
Louizalaan 489
1050 Brussels
Belgium
Stay FDA 21 CFR 11 compliant through efficiently controlled printing and reconciliation.
Tag every printed page for easy identification and retrieval
· Integrated Document Control
· Automated Training management
· Streamline CAPAs, Change Control, Non-conformities, Deviations
· Easily manage Audits, Risk Assessments
· Global monitoring of your Quality Management System
· Automated traceability matrix that connects thousands of items
· Integrated & effortless
· Documents and Training management
· Streamline CAPAs, Change Control, Non-conformities, Deviations
· Global vision of your R&D and QMS
Scilife has been fully validated by us according to GAMP/21CFR11.
The price includes the fully, drafted, executed and signed off validation documentation package which you can use as the basis for the validation of Scilife on your end. This effectively takes away most of the cost and effort of validation for our customers.
Database storage is included in the price.
Up to 1GB of file storage is included in the price, too. Additional file storage will be billed separately. The price depends on the amount of storage you will need.
Read only users have only read access to the information in the system. They can not create documents, report events, nor open CAPAs. They can not sign as creator, reviewer or approver. They can only sign off their trainings.
A full user is allowed to fully participate in all workflows. Allowed to initiate documents, trainings, events, CAPAs, change requests, etc. Allowed to sign as reviewer, approver, QA or any other role defined in the system. Can be appointed as manager or administrator if needed.
No, administrators and managers have the same cost as full users.
Any user that is not deleted. When a user no longer needs access to the system, that user can be deleted.
Traceability is extremely important in Scilife. Audit trails are always kept, and deleted items (users, documents, etc.) can always be recovered through the user interface.
We do a backup of all the data every 5 minutes. That means doing 288 backups per day. We have a backup retention policy of 30 days.
We offer customers the choice to host their data inside the EU or in the US. If you need to comply with GDPR your data will be hosted in a European data center.
Yes, it is included in the fee you pay. We will never charge you extra for customer support.
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
EMEA Office
Louizalaan 489
1050 Brussels
Belgium
US Office
Scilife Inc.
228 E 45th St. RM 9E
New York, NY 10017
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