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QMS Pharma & Biotech

The Smart Quality Management Software you need to control your processes and get your product to market, fast. 

Free

Unlimited free access to start your Smart Quality journey.

Start for free

FREE PLAN FEATURES

  • Unlimited users
  • Unlimited electronic signatures (21CFR11 compliant)
  • Unlimited Scilife Academy access

Documents 

  • Up to 20 documents

Training

  • Up to 5 Trainings

KPIs

  • KPI report

Essential

Empower quality culture. Start with the basics.

Contact us

ESSENTIAL PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Core

Comprehensive solution to manage quality smartly.

Contact us

CORE PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control

Core+

Unleash the power of streamlined processes.

Contact us

CORE+ PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control
  • Audits
  • Supplier Management
  • Risk Assessment
  • Equipment

All paid plans include:

  • Cloud infrastructure and software updates
  • GAMP5 validation documentation package for all updates
  • Unlimited customer support

Print & Reconciliation

Stay FDA 21 CFR 11 compliant

Contact us
feature check Issue a printout from any of your existing applications
feature check Reconcile rapidly with unique identifier barcodes
feature check Stay in the loop of who printed what, and when
feature check Log comments on individual issues, keeping traceability intact
feature check Stay organized with grouped printouts
feature check Up to 5 trainings

QMS Medical Device & IVD

The Smart Quality Management Software you need to control your processes and get your product to market, fast. 

Free

Unlimited free access to start your Smart Quality journey.

Start for free

FREE PLAN FEATURES

  • Unlimited users
  • Unlimited electronic signatures (21CFR11 compliant)
  • Unlimited Scilife Academy access

Documents 

  • Up to 20 documents

Training

  • Up to 5 Trainings

KPIs

  • KPI report

Essential

Empower quality culture. Start with the basics.

Contact us

ESSENTIAL PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Core

Comprehensive solution to manage quality smartly.

Contact us

CORE PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control

Core+

Unleash the power of streamlined processes.

Contact us

CORE+ PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control
  • Audits
  • Supplier Management
  • Risk Assessment
  • Equipment

All paid plans include:

  • Cloud infrastructure and software updates
  • GAMP5 validation documentation package for all updates
  • Unlimited customer support

Design & Development

Manage the whole process according to strict compliance regulations.

Contact us
feature check Integrated Risk Assessment
feature check Version Comparison Tool
feature check Single-click submissions
feature check Streamlined Process
feature check Full Traceability

QMS Medicinal Cannabis

The Smart Quality Management Software you need to control your processes and get your product to market, fast. 

Free

Unlimited free access to start your Smart Quality journey.

Start for free

FREE PLAN FEATURES

  • Unlimited users
  • Unlimited electronic signatures (21CFR11 compliant)
  • Unlimited Scilife Academy access

Documents 

  • Up to 20 documents

Training

  • Up to 5 Trainings

KPIs

  • KPI report

Essential

Empower quality culture. Start with the basics.

Contact us

ESSENTIAL PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Core

Comprehensive solution to manage quality smartly.

Contact us

CORE PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control

Core+

Unleash the power of streamlined processes.

Contact us

CORE+ PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control
  • Audits
  • Supplier Management
  • Risk Assessment
  • Equipment

All paid plans include:

  • Cloud infrastructure and software updates
  • GAMP5 validation documentation package for all updates
  • Unlimited customer support

QMS CRO/CMO

The Smart Quality Management Software you need to control your processes and get your product to market, fast. 

Free

Unlimited free access to start your Smart Quality journey.

Start for free

FREE PLAN FEATURES

  • Unlimited users
  • Unlimited electronic signatures (21CFR11 compliant)
  • Unlimited Scilife Academy access

Documents 

  • Up to 20 documents

Training

  • Up to 5 Trainings

KPIs

  • KPI report

Essential

Empower quality culture. Start with the basics.

Contact us

ESSENTIAL PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Core

Comprehensive solution to manage quality smartly.

Contact us

CORE PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control

Core+

Unleash the power of streamlined processes.

Contact us

CORE+ PLAN FEATURES

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control
  • Audits
  • Supplier Management
  • Risk Assessment
  • Equipment

All paid plans include:

  • Cloud infrastructure and software updates
  • GAMP5 validation documentation package for all updates
  • Unlimited customer support

QMS ATMP

The Smart Quality Management Software you need to control your processes and get your product to market, fast. 

Free

Unlimited free access to start your Smart Quality journey.

Start for free

FREE PLAN FEATURES

  • Unlimited users
  • Unlimited electronic signatures (21CFR11 compliant)
  • Unlimited Scilife Academy access

Documents 

  • Up to 20 documents

Training

  • Up to 5 Trainings

KPIs

  • KPI report

Essential

Empower quality culture. Start with the basics.

Contact us

ESSENTIAL PLAN FEATURES

Cell by Design:

  • Define QTPPs, CQAs, Process Maps
  • Integrated Risk Analysis
  • Unit Operation Analysis

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Core

Comprehensive solution to manage quality smartly.

Contact us

CORE PLAN FEATURES

Cell by Design:

  • Define QTPPs, CQAs, Process Maps
  • Integrated Risk Analysis
  • Unit Operation Analysis

Document & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control

Core+

Unleash the power of streamlined processes.

Contact us

CORE+ PLAN FEATURES

Cell by Design:

  • Define QTPPs, CQAs, Process Maps
  • Integrated Risk Analysis
  • Unit Operation Analysis

Documents & Records

  • Documents
  • Records

Knowledge

  • Training
  • Competences

KPIs

Processes
with predefined workflows

  • Deviations, non-conformities, complaints, other quality events
  • CAPAs
  • Change Control
  • Audits
  • Supplier Management
  • Risk Assessment
  • Equipment

All paid plans include:

  • Cloud infrastructure and software updates
  • GAMP5 validation documentation package for all updates
  • Unlimited customer support

Frequently Asked Questions

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.