INSIGHTS
Insights
Notes on digital manufacturing, compliance and the NEO platform.
GxP Compliance
GxP Compliance
Why electronic batch records are the backbone of GxP
Paper batch records slow release and hide errors. Here is how a digital EBR enforces the process and cuts review time.
Jun 18, 20261 min read
GxP Compliance
Computerized system validation without the paperwork spiral
GAMP 5 (2nd edition) rewards a risk-based, critical-thinking approach. Here is how to validate faster without cutting corners.
Jun 02, 20261 min read
GxP Compliance
Data integrity by design: what ALCOA+ really asks of your systems
Attributable, Legible, Contemporaneous, Original, Accurate — and Complete, Consistent, Enduring, Available. Systems should make these automatic.
Dec 12, 20251 min read