From target profile to design space.
QbD risk assessment and design of experiments software. Build the full quality-by-design record in one place: QTPP, CQAs, risk assessment, DoE, design space and control strategy.
- DefineQTPP · CQAs
- AssessIshikawa · REM · FMEA
- ExperimentDoE · Analysis
- ConcludeDesign space · Report
Aligned with ICH Q8(R2) · Q9(R1) · Q10
QbD Risk Navigator is browser-based software from Vsolv Research for applying Quality by Design to pharmaceutical development. It guides you through four stages: define the target profile and critical quality attributes, assess risk, design and analyse experiments, and conclude with an optimised design space and a PDF report. Your data stays in your browser.
Four stages, one complete QbD record
QTPP · CQAs
- Quality target product profile
- Critical quality attributes with justification
- Variable register of material attributes and process parameters
Ishikawa · REM · FMEA
- Ishikawa (cause-and-effect) diagram
- Risk estimation matrix with a live risk index
- FMEA with severity, occurrence, detection, RPN and Pareto chart
DoE · Analysis
- Screening, full factorial, Box–Behnken, central composite and mixture designs
- Run sheets, fitted models, ANOVA and equations in coded and actual units
- Contour plots and 3D response surfaces
Design space · Report
- Multi-response desirability optimisation
- Design space and confirmation runs checked against prediction intervals
- Control strategy and a PDF development report
Built for research and development work
Development report
One-click PDF titled Quality by Design Development Report, with your figures and tables.
600 dpi figures
Export charts as PNG or SVG and tables as CSV, ready for theses and journals.
Level 1 traceability
Change log, electronic signatures with meaning, and a SHA-256 checksum on every export.
Data stays with you
Projects are stored in your browser. Nothing is uploaded to our servers.
Works on any device
Desktop, tablet and phone, in any modern browser.
Guided at each step
Built-in guide texts explain what to enter and why, including the theory behind each index.
Decision-support tool. Not a validated GMP or 21 CFR Part 11 system. Check results against your own data and procedures before use in regulated decisions.
Questions about QbD Risk Navigator
Where is my project data stored?
In your own browser on your device. It is not uploaded to our servers. Export your projects regularly as a backup, because clearing browser data deletes them. You can keep up to 10 projects at a time.
Can I use it for my thesis or publication?
Yes. Export figures at 600 dpi and tables as CSV. Describe the software and version in your methods section.
Is it validated for GMP use?
No. It is a decision-support tool with Level 1 traceability (change log, signatures and integrity checks). It is not a validated 21 CFR Part 11 system, so GMP records must stay in your validated systems.
Which experimental designs are supported?
Screening designs, full factorial, Box–Behnken, central composite (with a choice of axial distance) and mixture designs, with fitted models, ANOVA, equations, contour plots and 3D response surfaces.
Start your first QbD project today
No installation. Runs in your browser.