SUS CPV Sentinel
Stage 3 Continued Process Verification for Single-Use Systems
USP <665> became enforceable 1 May 2026. End users now bear regulatory responsibility for assessing Process Equipment-Related Leachables across their full plastic manufacturing train. ASTM E3051-25 (January 2025) requires digital data management for SUS qualification and continued verification. This tool operationalizes both requirements as a validated Python/Streamlit platform.
SCN Reference: SCN-CYT-2025-0114 · Film resin change · Q4 2025
Rule: ASTM E3051-25 §6 / PDA TR 66 §9
Audit entry: a3f8c2d1e5b7... → prev: 7e4b91a0c3d2...
Validation Package: VP · URS (51 req) · Risk Assessment (FMEA) · IQ Protocol · OQ Protocol (13 cases) · PQ Protocol (6 cases) · RTM (100% coverage) · Validation Summary Report
GxP Dashboard Prototypes
QMS Insights Dashboard
Computerized system health monitoring across the validated instrument fleet. CAPA tracking, audit trail review status, periodic review scheduling.
Audit Trail Sentinel
ALCOA+ data integrity scanner for GxP systems. Detects audit trail gaps, missing reason-for-change fields, and timestamp anomalies across 21 CFR Part 11 systems.
SUS Lot Genealogy Monitor
CPV Bridge for single-use systems. Lot genealogy traceability, pressure-decay trending, supplier change notification tracking aligned to ASTM E3051-25.
Justin Arndt
Regulated AI and data validation engineer with hands-on GxP experience at pharmaceutical manufacturing sites. Focused on the intersection of modern data engineering and life sciences compliance.
Validation & Compliance
- GAMP 5 IQ/OQ/PQ lifecycle
- 21 CFR Part 11 / ALCOA+
- Kneat Gx execution
- Veeva Vault QualityDocs
- FDA Process Validation Stage 3
- Change control & risk assessment
Data & Analytics
- Python · pandas · scipy · numpy
- Statistical Process Control (SPC)
- Cpk/Ppk · Shewhart · Hotelling T²
- Streamlit · Plotly dashboards
- LIMS integration · SQL
- AI/ML in GxP contexts