Paramus QbD
Quality-by-Design and quality management for pharma (ICH Q8 / Q9 / Q10 / Q11) and oil and gas (API Q1 / Q2, ISO 29001). Tracks development programs across the full QbD lifecycle: CQAs, CPPs, proven acceptable ranges, FMEA with RPN, DoE design space runs, deviations and change controls, and regulator and customer submissions.
Features
- Industry profiles: pharma API, pharma DP, oil and gas
- Workflow stages with per-stage status and progress
- CQA / CPP / PAR with cross-linking and PAR status
- FMEA with severity, occurrence, detection and computed RPN
- DoE design space runs and deviation / change control register
- Submission tracking: IND, NDA, CTD, customer audit
- MCP tools: 53 (full CRUD across 9 entities)