Capability Model
Manufacturing Hub capability map with maturity levels
About this view
The capability model maps all functional areas of the Manufacturing Hub against a 5-level maturity scale. Level 1 = Basic tracking, Level 2 = Workflow automation, Level 3 = Integrated analytics, Level 4 = Predictive intelligence, Level 5 = Autonomous/AI-driven.
Level 5 Capabilities
12
Fully automated
Level 4 Capabilities
9
AI-enhanced
Level 3 Capabilities
4
Analytics integrated
Total Domains
9
25 capabilities
Shop Floor
Electronic Batch Records
Digital execution of manufacturing instructions with e-signatures and audit trail.
L5
Production Board
Real-time control tower showing all lines, batch progress, and exceptions.
L5
Review by Exception
AI-filtered exception queue reducing review time by 60%.
L4
Materials
Lot Genealogy
Full bi-directional traceability from API to finished goods with visual tree.
L5
Inventory Management
Real-time inventory with quarantine, hold, and expiry management.
L4
Serialization
Item-level serialization and aggregation for track & trace compliance.
L3
Equipment
Calibration Management
Schedule-driven calibration with certificate management and overdue alerts.
L5
Preventive Maintenance
PM work orders with parts tracking and OEE integration.
L4
Cleaning Validation
Automated cleaning records with residue limits and product changeover.
L4
Quality
Deviation Management
End-to-end deviation lifecycle with risk scoring and regulatory flagging.
L5
CAPA Lifecycle
Corrective and preventive actions with effectiveness checks and aging reports.
L5
Change Control
Multi-step change approval with impact assessment and validation tracking.
L5
QC & Lab
OOS/OOT Workflow
Structured out-of-specification investigation per USP <1010>.
L5
Sample Management
Chain of custody, sample login, and result review workflow.
L4
Stability Studies
ICH-compliant stability programs with interval tracking and trending.
L3
Release
Release Readiness Scoring
Automated scoring of all release criteria with traffic-light dashboard.
L5
Batch Disposition
QA disposition workflow with conditional release and quarantine management.
L5
COA Generation
Automated Certificate of Analysis generation from QC results.
L4
AI
Deviation Summarizer
LLM-powered plain-language summaries of complex deviation reports.
L4
Release Readiness Checker
AI review of all batch data before QA sign-off.
L4
Shift Handover Composer
Auto-generated structured shift reports from batch execution data.
L3
Compliance
21 CFR Part 11 Audit Trail
Immutable audit trail for all GxP-relevant data changes.
L5
Access Control Matrix
Role-based permissions with persona-driven visibility control.
L5
Planning
Capacity Planning
Constraint-based scheduling with equipment and material availability.
L3
OEE Analytics
Overall Equipment Effectiveness calculation with loss categorization.
L4