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Pricing Plans

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Find out more about our package offerings below!

Aligned Elements

Design Control ALM

650€

per month
Incl. 2 Floating Licenses
billed yearly

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  • Full Design Control Mgmt
  • ISO 14971 Risk Management
  • End-to-End Traceability
  • Auto-Consistency Checks

Aligned eQMS

Starter Package

Popular

1000€

per month
Incl. 3 Floating Licenses
billed yearly

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  • All Aligned Elements Features
  • 14 SOP:s and 55 Templates
  • Document & E-Signature Support
  • Training Management
  • Supplier Managemenet

Aligned eQMS

Full Package

2085€

per month
Incl. 5 Floating Licenses
billed yearly

Request a Quote
  • All Aligned Elements Features
  • 31 SOP:s and 100+ Templates
  • Quality Event Management
  • Audit Management
  • Equipment Managemenet

Aligned Elements

Design Control ALM

400€

per month
Incl. 2 Floating Licenses
billed yearly

Request a Quote
  • Full Design Control Mgmt
  • ISO 14971 Risk Management
  • End-to-End Traceability
  • Auto-Consistency Checks

Aligned eQMS

Starter Package

Popular

850€

per month
Incl. 3 Floating Licenses
billed yearly

Request a Quote
  • All Aligned Elements Features
  • 14 SOP:s and 55 Templates
  • Document & E-Signature Support
  • Training Management
  • Supplier Managemenet

Aligned eQMS

Full Package

1830€

per month
Incl. 5 Floating Licenses
billed yearly

Request a Quote
  • All Aligned Elements Features
  • 31 SOP:s and 100+ Templates
  • Quality Event Management
  • Audit Management
  • Equipment Managemenet

Compare Plans

  Aligned Elements eQMS Starter eQMS Full
  • Design Control Management
    Flexible Requirement Management
    ISO 14971 Risk Management
    AI-Driven Verification Management
    Design Validation Management
    End-to-End Traceability
    Automated Consistency Checks
    Integrated Design Reviews
    Use Scenario & Task Management
    Powerfull Tech Doc Reporting
    Integrated DHF Index
    E-Signatures 2000 EUR
  • QMS Content
    Included SOP:s - SOP100 Management
    SOP101 Human Resources
    SOP200 Design and Development
    SOP204 Software Development
    SOP208 Cybersecurity Management
    SOP209 Released Software Management
    SOP300 Documents and Records
    SOP301 Performance Evaluation
    SOP302 Change Management
    SOP304 Supplier Handling
    SOP305 Risk Management
    SOP306 Usability Engineering
    SOP307 Labeling
    SOP308 Validation of Computer Software    		 All SOP:s in Starter Pack
    SOP102 Audits
    SOP103 PMS
    SOP104 Complaints and Vigilance
    SOP105 Corrective and Preventive Action
    SOP106 Nonconforming Product
    SOP201 Purchasing
    SOP202 Production
    SOP203 Sales
    SOP205 Incoming Inspection
    SOP206 Storage Packaging Delivery
    SOP207 Technical Service
    SOP301 Clinical Evaluation
    SOP303 Infrastructure
    SOP309 Statistically Valid Sampling
    SOP310 Process Validation
    SOP311 Equipment Control
    SOP312 Device Cleanliness Sterilization Contamination Control
  • Training Management
    Automated Action Assignment -
    Training/Document Linking -
    Training Progress Tracking -
  • Change Management
    Change Request Management -
    Change Request Planning -
    Change Request Reporting -
  • Supplier Management
    Supplier Selection & Approval -
    Supplier Handling -
    Supplier Re-Evaluations -
  • Computer System Validation Management
    Software Tool Library -
    Risk-Based Validation Assessment -
    GMP & FDA 21 CFR Part 11 Assessment -
    Validation Planning -
    Validation Reporting -
    Periodic Re-evaluation -
  • Quality Event Management
    Feedback & Complaints Management - -
    Nonconforming Products - -
    Nonconformity Assessments - -
    CAPA Management - -
    Vigilance Reporting Management - -
  • Audit Management
    Audit Program Management - -
    Audit Planning - -
    Audit Reporting - -

Additional Packages

Getting up and running fast is important for most of our customers. To provide best possible fit between Aligned Elements and your existing organization, we offer the following add-ons:

Aligning with your Development Process

We configure Aligned Elements according to your quality management system for seamless integration with your existing Development processes and templates.

3500 €

On-site User Training

Full-day training of up to 12 of your employees on your company site. The training warrents a certificate of completion if the final test is passed.

2500 €

Online User Training

Four two-hour online sessions for 12 users. The training warrants a certificate of completion if the final test is passed.

1200 €

Integration with External System

Integrate Aligned Elements with Jira, TFS, Enterprise Architect, GitHub and many other system to get the most out of your existing infrastructure.

2000 €

Integration with Automated SW Verification

Leverage existing automated software tests in your traceability. Integrate Aligned Elements into your continuous build chain and automatically export results from your automated software tests into Aligned Elements. 

2000 €

Deployment, Quick Start and Validation Services

If you need further help, we assist you with tasks such as:

  • Server installation support
  • Transfer support of existing documentation into Aligned Elements
  • Validation support
  • Advice on Design Control structuring

Request a quote today!

Ask us for a tailored pricing quote!