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ISA-95 · FDA 21 CFR Part 11 · AS9100 Rev D

MES Requirements Checklist

70+ requirements across 9 functional areas for MES implementation in regulated manufacturing — production scheduling, WIP tracking, quality management, genealogy, ERP/SCADA integration, validation readiness, OEE, and document management. Status, Priority, Owner, and Notes columns per requirement.

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What’s Inside
Production Scheduling & Dispatch
Work order release, queue management, finite capacity, split orders, rush override, OTD reporting
WIP Tracking & Shop Floor Control
Real-time WIP location, labour reporting, yield & scrap, rework routing, digital traveller
Quality Management (SPC, NCMR, Hold)
In-process inspection, SPC charts, NCMR workflow, hold management, RCCA linkage, FPY & RTY
Genealogy & Traceability
Forward/reverse lot traceability, as-built records, shelf-life/FIFO, recall simulation, UDI
ERP Integration (SAP / Oracle)
Work order sync, GR posting, master data alignment, batch management, integration error handling
SCADA / PLC Integration
OPC-UA, Modbus, machine state, downtime capture, process parameter logging, edge gateway
Validation Readiness
21 CFR Part 11 e-signatures, immutable audit trail, IQ/OQ/PQ, GAMP5 classification, data retention
OEE, Document & Recipe Management
OEE calculation, shift reports, Andon, work instruction linkage, recipe version control, EBR
How to Use It
01
Open in Word or Google Docs
Rename with your project name and facility before starting.
02
Mark Status per requirement
Yes = fully met. Partial = in progress or workaround. No = gap. Work section by section with your team or vendor.
03
Assign Owner and Priority
High-priority No responses are critical risks. Assign a named owner — not a team — for accountability.
04
Capture gaps in the Notes column
Specific gaps, workarounds, open questions. This becomes your vendor RFP input or project risk register.
05
Tally and prioritise
Count High-priority No responses per section. Use the output to drive vendor evaluation or project scoping.
MES Requirements Checklist
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Shashikant Pradhan
Senior PM · MES & IIoT Consultant · Author, The Technical Floor · MDEC Systems
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