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j-arndt/README.md

Justin Arndt

Regulated AI & Data Validation Engineering for Pharmaceutical Manufacturing

Pinned -- SUS CPV Sentinel

USP <665> became enforceable 1 May 2026. End users now bear regulatory responsibility for assessing Process Equipment-Related Leachables (PERLs) across their entire plastic manufacturing train. ASTM E3051-25 (January 2025) requires digital data management for SUS qualification and continued verification.

sus-cpv-sentinel -- Stage 3 Continued Process Verification for Single-Use Systems

  • GAMP 5 Category 4 | Fully validated | 51 URS requirements | 39/39 test cases
  • Cpk/Ppk per SKU | Shewhart I-MR | Hotelling T2 | Supplier SCN Scorecard
  • ALCOA+-compliant SHA-256 hash-chained audit trail | 21 CFR Part 11
  • Complete validation package: VP | URS | FMEA | IQ | OQ | PQ | RTM | VSR
  • Kneat Gx execution | Veeva Vault QualityDocs document control

Regulatory Alignment

Standard Scope
FDA Process Validation (2011) Stage 3 Continued Process Verification framework
ASTM E3051-25 (January 2025) SUS digital data management and qualification
PDA Technical Report No. 66 SUS E&L monitoring, supplier qualification
USP <665> (effective 1 May 2026) PERL assessment, plastic manufacturing train
21 CFR Part 11 / ALCOA+ Electronic records, audit trail, data integrity
GAMP 5 Second Edition (2022) Risk-based validation, Category 4 software
ICH Q9(R1) FMEA-based quality risk management

Focus

Closing the gap between pharmaceutical SUS process data, FDA Stage 3 CPV requirements, and regulatory audit readiness through validated, ALCOA+-compliant analytical platforms.

j-arndt.github.io -- Portfolio and interactive demos

linkedin.com/in/qualityai -- LinkedIn

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