BiOS
Capability Gap Assessment
Northwind Cell Systems
Excerpt · Have vs. need
Confidential · Sample
Current state vs. next-level operating capability
Northwind aims to release its first GMP lot within 14 months. The excerpt compares what exists today with what is required for that next level—systems, roles, and decision rights.
| Capability | Have today | Need for next level | Gap type |
|---|---|---|---|
| Batch record ownership | Dev notebooks + informal templates | Controlled MBR/EBR with deviation path | System + process |
| Material master / BOM governance | Spreadsheet BOM per experiment | Versioned BOM with change control | System |
| QA release decision rights | Founder + consultant dual review | Named QP/QA authority with backup | People + ownership |
| Scheduling & capacity visibility | Weekly standup whiteboard | Campaign plan with constraint flags | Process |
| Supplier qualification | Preferred list, no formal risk tiering | Tiered qualification for critical materials | Process + compliance interface |
Sequencing note
Close ownership and BOM governance before tooling spend. A better scheduler on top of unclear decision rights will not reduce lot risk.
Full sample includes 90/180/365 capability roadmap (not shown).