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,...
TL;DR · MES architecture ISA-95 in 60 words ISA-95 (IEC 62264) is the international standard for MES architecture. Five levels: L0 physical process, L1 sensors/actuators, L2 SCADA/PLC, L3 MES (operations), L4 ERP (business). Four operations: production, maintenance,...
TL;DR · Predictive maintenance ML in 60 words Predictive maintenance combines condition monitoring (vibration ISO 10816/20816, acoustic, thermal, oil ISO 4406) with machine learning models trained on time-series sensor data. Standards ISO 17359 (CBM principles), ISO...
TL;DR · IEC 62443-3-3 in 60 words IEC 62443-3-3:2013 specifies System Security Requirements (SR) for IACS, organized by 7 Foundational Requirements (FR1-7). Each FR contains 1-4 SR per Security Level (SL1-4), totaling 100+ technical controls. Most-referenced document...
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