TL;DR · Pharma FDA 21 CFR Part 11 validation in 60 words FDA 21 CFR Part 11 (1997) regulates electronic records + electronic signatures equivalent to paper. Validation methodology: GAMP 5 (5 software categories), IQ/OQ/PQ protocols, ALCOA+ data integrity principles....
TL;DR · Aerospace AS9100 MES implementation in 60 words AS9100D:2016 is the aerospace QMS standard (ISO 9001 + aerospace-specific). MES implementation 2027 must support: configuration management per unit (each unit), First Article Inspection (FAI) AS9102, NADCAP...
TL;DR · MES vs ERP vs Historian in 60 words ERP (L4, days-months): business planning, finance, orders, customers, SAP, Oracle. MES (L3, minutes-hours): operations execution, recipes, traceability, OEE · Siemens Opcenter, Aveva, Werum. Historian (L2,...
