For Solid Oral Products
- QTPP and CQA identification
- Excipient and API risk assessment
- Granulation and compression parameter mapping
- Dissolution optimization tracking
- DOE planning and statistical evaluation
- Control strategy development
Pharma R&D Platform
Science-Driven QbD Platform for Pharma Development
A centralized web-based Quality by Design platform for Solid Oral and Sterile Injectable product development, helping formulation teams perform structured risk assessment, QTPP mapping, DOE planning, design space evaluation, and control strategy development aligned with ICH guidelines.
EzyQbD stores user access data, approvals, membership dates, and login logs in the database. Formulation, project, and uploaded development content should remain temporary and non-persistent.
ICH aligned
Q8, Q9, Q10, Q11 and Q14 ready workflow structure
Two product tracks
Solid Oral and Sterile Injectable development paths in one workspace
Membership-controlled access
Admins approve users, assign expiry dates, and access ends automatically when membership expires
For Sterile Injectable Products
- Sterility-focused QbD workflows
- Filtration and aseptic process risk mapping
- Endotoxin and particulate control analysis
- Container closure integrity tracking
- Lyophilization parameter evaluation
- Process robustness assessment
Security
Persistent access control with temporary development data handling
What EzyQbD Stores
- User registration details
- Admin approval status
- Membership start and expiry dates
- Login and audit trail activity
What Should Remain Temporary
- Formulation and product development inputs
- Uploaded working files and draft studies
- DOE data, QTPP, CQA, and risk assessment workbooks
- Project content intended for export-first workflows
Why EzyQbD
Structured development logic with practical execution support
| Feature | Description |
|---|---|
| Centralized QbD Workflow | Manage complete development lifecycle in one platform |
| Risk-Based Development | Identify and mitigate formulation and process risks |
| DOE Integration | Structured experimental planning and analysis |
| Regulatory Alignment | Designed around ICH Q8, Q9, Q10, Q11 and Q14 principles |
| Collaborative Platform | Enable R&D, analytical and regulatory teams to work together |
| Report Generation | Generate structured QbD documentation instantly |
Modules Overview
Core workspaces for modern QbD execution
QTPP Builder
Define target product profile including dosage form, route, release profile, stability requirements and patient considerations.
CQA Identification
Identify critical quality attributes based on product category and formulation strategy.
Risk Assessment
Perform FMEA-based risk analysis for materials, processes and analytical methods.
DOE Workspace
Plan and evaluate formulation/process optimization studies.
Design Space
Visualize acceptable operational ranges and process robustness.
Control Strategy
Establish IPCs, specifications and lifecycle monitoring strategy.