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Scilife smart QMS Plans for Medical Devices

Link your development and quality management processes ensuring total compliance and bring your products to the market faster.

Free

Unlimited free access to start your Smart Quality journey

  • Up to 20 Documents
  • Up to 5 Training
  • KPIs
  • Unlimited Users
  • Unlimited electronic signatures (21CFR11 compliant)
  • Unlimited Scilife Academy access
  • * No credit card required
Essential

Let no compliance slip through the cracks

  • Design & Development
  • Documents
  • Records
  • Training
  • Competences
  • KPIs
- Most Popular -
Core

Everything you need to efficiently manage your quality system

  • Design & Development
  • Documents
  • Records
  • Training
  • Competences
  • KPIs
  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control
Core +

The comprehensive solution to manage quality smartly

  • Design & Development
  • Documents
  • Records
  • Training
  • Competences
  • KPIs
  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control
  • Audits
  • Supplier Management
  • Risk Assessment
  • Equipment
Do more with Scilife
Additional tools that multiply efficiency

Print & Reconciliation
Stay FDA 21 CFR 11 compliant

· Centralized process for the issuance and retrieval of printed documents.

· Spotless audit trail where every detail is captured (what, who, when, why).

· Use of barcodes to speed up and digitize reconciliation.

· Take immediate action on reconciliation issues.

Pricing_P&R
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
Compare ours Plans
 

Free

Essential

Core

Core +

Key Capabilities

Number of users
No limit
Custom
Custom
Custom
User task list
Comments functionality
Tags system
Multi-level groups system
Permissions system
Multifactor Authentication
User Access Control
IP address whitelisting/blacklisting
Electronic Signatures (21CFR11 compliant)
Audit Trail
Email notifications repository
Export any list (xls/csv)
Automated workflow diagrams
Deleted items management
System Log
Personalized notifications sender account
Internal Chat system
In-app guided tour
Knowledge base access
Scilife Academy access
Training videos
Multi-language user interface (EN, ES, FR, NL)
SSL certificate
Online Service Desk
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Customer Success representative
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Onboarding guidance
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Full validation documentation package (GAMP5)
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Three Scilife environments: Test, Validation, Production
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1:1 Technical support
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Design & Development

Automated traceability matrix
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Version comparison tool
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Workflow for approvals and sign-offs during design reviews
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DHF Export
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Coming soon
Coming soon
Coming soon
Risk assessments automatically linked
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Coming soon
Coming soon
Coming soon

Documents & Records

Number of Documents
20
No limit
No limit
No limit
Document Types manager
Live document editing (in the cloud)
Microsoft Office integration
Linked documents
Document annotations system
Controlled printing
Document folders functionality
Document tree view / list view
Document templates support
Document metadata variables support
Version control
Review and Approval workflow
Automated periodic document reviews
Automated or manual retraining at document level
Records Form Builder
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Training & Competences

Number of Trainings
5
No limit
No limit
No limit
Training management
Automated or manual retraining
User functions
Training assessments
Offline users
Competences management
-
Automated or manual competence updates
-
CV Form Builder
-
CV review and approval workflow
-
CV Exporter
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KPIs

KPI report dashboards
Overdue Task Management
Benchmark comparison
Quality Management Reports
Reports and KPIs data export

Quality Management

Quality Event management (Deviations, Non-conformities, Complaints...)
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Custom Quality Event fields for registration and investigation
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CAPAs management
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Link CAPA actions to document updates
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Change Control
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-
Change Control Effectiveness Check
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Link Change Requests to document updates
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-
Audits Management (Internal, External and Incoming)
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-
-
Supplier Management
-
-
-
Risk Management
-
-
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Recurrent Risk Management Tasks Configuration
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Equipment Maintenance: Qualification & Calibration Management
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See for yourself

Get going with Scilife and see what we can do for your organization.

 

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Try for Free

Get started today with the free version of Scilife—no strings attached.

 

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FAQs
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 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.