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Scilife Print & Reconciliation Plan

Stay FDA 21 CFR 11 compliant through efficiently controlled printing and reconciliation.

Print & Reconciliation

Tag every printed page for easy identification and retrieval

  • Printout from any of your existing applications
  • Reconcile rapidly with unique identifier barcodes
  • Stay in the loop of who printed what, and when
  • Log comments on individual issues, keeping traceability intact
  • Stay organized with grouped printouts
Do more with Scilife
Additional tools that multiply efficiency

Smart QMS
All-in-one, compliant & centralized system

· 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


Smart QMS for Medical Devices
Streamline development and quality with full traceability

· 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

Trusted by leading quality-focused organizations in the life sciences
  • Logo of Polpharma, a Scilife QMS customer
  • Logo of Novartis, a Scilife QMS customer
  • Logo of Puro, a Scilife QMS customer
  • Logo of CellPoint, a Scilife QMS customer
  • Logo of Biocartis, a Scilife QMS customer
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Is Scilife validated according to GAMP5 and 21CFR11?

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.

Does the price include storage?

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.

What can a read only user do?

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.

What can a full user do?

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.

Is the license for an administrator or a manager more expensive?

No, administrators and managers have the same cost as full users.

What is an active user?

Any user that is not deleted. When a user no longer needs access to the system, that user can be deleted.

What happens to the audit trail of deleted users?

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.

Do you do backups?

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.

Where is my data hosted? Will I be compliant with GDPR?

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.

Is customer support included in the annual license?

Yes, it is included in the fee you pay. We will never charge you extra for customer support.