Demo baseline (stand-in data)
Date: 2026-01-14
Hard constraints (cGMP, hold times, shared resources)
Structural uncertainty (durations, QC release delays)
Excel-driven planning creates late surprises
Primary: campaign sequence + staffing coverage (6-10 weeks)
Secondary: suite/bioreactor vs QC delay lever
Owners: Planning + QA/QC + Production
Single product family, end-to-end flow
Top resources only
Out of scope: ERP/MES replacement, GMP validation
Activities: DS -> DP -> Fill -> QC -> Release
Resources: bioreactor, suites, fill line, QC, cold storage
Constraints: precedence, capacity, hold-time max, time windows
Conservative (P_success 0.93)
Balanced (P_success 0.82)
Aggressive (P_success 0.67)
| Scenario | Reliability | Throughput | Overtime |
| --- | --- | --- | --- |
| Conservative | 0.93 | 8 / week | 5 hrs |
| Balanced | 0.82 | 10 / week | 9 hrs |
| Aggressive | 0.67 | 12 / week | 16 hrs |
Resource: bioreactor and suite capacity saturation
Activity: QC duration variance
Constraint: hold-time max between QC and Release
Recommend Balanced
Tradeoff: +throughput vs moderate overtime and accepted risk
Backed by KPI table + risk drivers
Swap in real site data (M2)
Re-run baseline (M4) and scenarios (M5)
Execute adoption test on next planning cycle