Pricing: Choose the best product for you
QMS software plans for medical devices
eQMS designed for medical devices — find the right pricing and plan for your team’s size, scale, and needs.
Free
Unlimited free access to start your Smart Quality journey
- Unlimited users
- Unlimited electronic signatures
- Scilife Academy access
- KPIs
- Up to 20 documents
- Up to 5 trainings
Essential
Let no compliance slip through the cracks
- Design and Development
- Unlimited documents
- Unlimited trainings
- Competences
- Records
Core
Everything you need to manage your quality system
- CAPAs
- Change control
- Quality events (deviations, non-conformities, complaints, event management)
Core +
Your all-in-one solution for smart quality management
- Audits
- Supplier management
- Risk assessment
- Equipment
All-in-one compliant & centralized system.
- Integrated document control.
- Automated training management.
- Streamline CAPAs, change control, non-conformities, deviations.
- Easily manage audits and risk assessments.
- Global monitoring of your quality management system.
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.
- Custom users
- 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
- Access to our Customer Success Experts
- Onboarding guidance
- Full validation documentation package (GAMP5)
- Three Scilife environments: Test, Validation, Production
- 1:1 Technical support
- Custom users
- 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
- Access to our Customer Success Experts
- Onboarding guidance
- Full validation documentation package (GAMP5)
- Three Scilife environments: Test, Validation, Production
- 1:1 Technical support
- Custom users
- 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
- Access to our Customer Success Experts
- Onboarding guidance
- Full validation documentation package (GAMP5)
- Three Scilife environments: Test, Validation, Production
- 1:1 Technical support
- Custom users
- 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
- Access to our Customer Success Experts
- Onboarding guidance
- Full validation documentation package (GAMP5)
- Three Scilife environments: Test, Validation, Production
- 1:1 Technical support
- Automated traceability matrix
- Version comparison tool
- Workflow for approvals and sign-offs during design reviews
- Automated traceability matrix
- Version comparison tool
- Workflow for approvals and sign-offs during design reviews
- Automated traceability matrix
- Version comparison tool
- Workflow for approvals and sign-offs during design reviews
- Automated traceability matrix
- Version comparison tool
- Workflow for approvals and sign-offs during design reviews
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- KPI report dashboards
- Overdue Task Management
- Benchmark comparison
- Quality Management Reports
- Reports and KPIs data export
- KPI report dashboards
- Overdue Task Management
- Benchmark comparison
- Quality Management Reports
- Reports and KPIs data export
- KPI report dashboards
- Overdue Task Management
- Benchmark comparison
- Quality Management Reports
- Reports and KPIs data export
- KPI report dashboards
- Overdue Task Management
- Benchmark comparison
- Quality Management Reports
- Reports and KPIs data export
- Quality Event management (Deviations, Non-conformities, Complaints...)
- Custom Quality Event fields for registration and investigation
- CAPAs management
- Link CAPA actions to document updates
- Change Control
- Change Control Effectiveness Check
- Link Change Requests to document updates
- Audits Management (Internal, External and Incoming)
- Supplier Management
- Risk Management
- Recurrent Risk Management Tasks Configuration
- Equipment Maintenance: Qualification & Calibration Management
- Quality Event management (Deviations, Non-conformities, Complaints...)
- Custom Quality Event fields for registration and investigation
- CAPAs management
- Link CAPA actions to document updates
- Change Control
- Change Control Effectiveness Check
- Link Change Requests to document updates
- Audits Management (Internal, External and Incoming)
- Supplier Management
- Risk Management
- Recurrent Risk Management Tasks Configuration
- Equipment Maintenance: Qualification & Calibration Management
- Quality Event management (Deviations, Non-conformities, Complaints...)
- Custom Quality Event fields for registration and investigation
- CAPAs management
- Link CAPA actions to document updates
- Change Control
- Change Control Effectiveness Check
- Link Change Requests to document updates
- Audits Management (Internal, External and Incoming)
- Supplier Management
- Risk Management
- Recurrent Risk Management Tasks Configuration
- Equipment Maintenance: Qualification & Calibration Management
- Quality Event management (Deviations, Non-conformities, Complaints...)
- Custom Quality Event fields for registration and investigation
- CAPAs management
- Link CAPA actions to document updates
- Change Control
- Change Control Effectiveness Check
- Link Change Requests to document updates
- Audits Management (Internal, External and Incoming)
- Supplier Management
- Risk Management
- Recurrent Risk Management Tasks Configuration
- Equipment Maintenance: Qualification & Calibration Management
Free
- Custom users
- 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
- Access to our Customer Success Experts
- Onboarding guidance
- Full validation documentation package (GAMP5)
- Three Scilife environments: Test, Validation, Production
- 1:1 Technical support
- Automated traceability matrix
- Version comparison tool
- Workflow for approvals and sign-offs during design reviews
- 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
- 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
- KPI report dashboards
- Overdue Task Management
- Benchmark comparison
- Quality Management Reports
- Reports and KPIs data export
- Quality Event management (Deviations, Non-conformities, Complaints...)
- Custom Quality Event fields for registration and investigation
- CAPAs management
- Link CAPA actions to document updates
- Change Control
- Change Control Effectiveness Check
- Link Change Requests to document updates
- Audits Management (Internal, External and Incoming)
- Supplier Management
- Risk Management
- Recurrent Risk Management Tasks Configuration
- Equipment Maintenance: Qualification & Calibration Management
Essential
- Custom users
- 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
- Access to our Customer Success Experts
- Onboarding guidance
- Full validation documentation package (GAMP5)
- Three Scilife environments: Test, Validation, Production
- 1:1 Technical support
- Automated traceability matrix
- Version comparison tool
- Workflow for approvals and sign-offs during design reviews
- 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
- 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
- KPI report dashboards
- Overdue Task Management
- Benchmark comparison
- Quality Management Reports
- Reports and KPIs data export
- Quality Event management (Deviations, Non-conformities, Complaints...)
- Custom Quality Event fields for registration and investigation
- CAPAs management
- Link CAPA actions to document updates
- Change Control
- Change Control Effectiveness Check
- Link Change Requests to document updates
- Audits Management (Internal, External and Incoming)
- Supplier Management
- Risk Management
- Recurrent Risk Management Tasks Configuration
- Equipment Maintenance: Qualification & Calibration Management
Core
- Custom users
- 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
- Access to our Customer Success Experts
- Onboarding guidance
- Full validation documentation package (GAMP5)
- Three Scilife environments: Test, Validation, Production
- 1:1 Technical support
- Automated traceability matrix
- Version comparison tool
- Workflow for approvals and sign-offs during design reviews
- 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
- 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
- KPI report dashboards
- Overdue Task Management
- Benchmark comparison
- Quality Management Reports
- Reports and KPIs data export
- Quality Event management (Deviations, Non-conformities, Complaints...)
- Custom Quality Event fields for registration and investigation
- CAPAs management
- Link CAPA actions to document updates
- Change Control
- Change Control Effectiveness Check
- Link Change Requests to document updates
- Audits Management (Internal, External and Incoming)
- Supplier Management
- Risk Management
- Recurrent Risk Management Tasks Configuration
- Equipment Maintenance: Qualification & Calibration Management
Core +
- Custom users
- 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
- Access to our Customer Success Experts
- Onboarding guidance
- Full validation documentation package (GAMP5)
- Three Scilife environments: Test, Validation, Production
- 1:1 Technical support
- Automated traceability matrix
- Version comparison tool
- Workflow for approvals and sign-offs during design reviews
- 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
- 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
- KPI report dashboards
- Overdue Task Management
- Benchmark comparison
- Quality Management Reports
- Reports and KPIs data export
- Quality Event management (Deviations, Non-conformities, Complaints...)
- Custom Quality Event fields for registration and investigation
- CAPAs management
- Link CAPA actions to document updates
- Change Control
- Change Control Effectiveness Check
- Link Change Requests to document updates
- Audits Management (Internal, External and Incoming)
- Supplier Management
- Risk Management
- Recurrent Risk Management Tasks Configuration
- Equipment Maintenance: Qualification & Calibration Management
Frequently Asked Questions
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?
A basic amount of storage is included, depending on your contract.
File storage is calculated based on the documents and items stored in your Production Environment only, which you can monitor directly within your Scilife application. Please contact us for more details about storage options.
What can a read only user do?
Read only users have access to view information in the system but cannot make any changes. They cannot create documents, report events, or open CAPAs. They also cannot sign as a creator, reviewer, or approver. The only action they can perform is signing off their assigned trainings.
What can a full user do?
A full user has access to participate in all workflows. They can initiate documents, trainings, events, CAPAs, change requests, and more. They are also permitted to sign as a reviewer, approver, QA, or any other role defined in the system. If needed, they can also be assigned as a manager or administrator.
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?
Your data will be hosted in a European or US data center. 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 your selected plan, with no extra fees. We will never charge you extra for customer support.




