Pharma · Food · Semiconductor · Seaports · Airports
Operations digitalization for plants that get audited
Five industries, five different rulebooks — EU-GMP, FSSC 22000, SEMI E10, port MMBF, airport AHM. No single generic solution fits all five, so each is built to its own industry's standard.
Services
Three things I do for a plant
From assessing the gap against the industry standard, to validating systems, to building the data infrastructure and the operations software that runs on it.
Compliance & industry operating standards
Gap assessment between how the plant actually runs and the standard its industry is held to, then a roadmap to close that gap.
- Pharma: EU-GMP, PIC/S, WHO-GMP — URS, SOP, VMP authoring
- Food: FSSC 22000, ISO 22002-100, Codex HACCP
- Semiconductor, seaports, airports: SEMI E10/E58, AHM, ISAGO
- Audit preparation and CAPA remediation
System validation (CSV / GAMP 5)
Documented evidence that a system does what it is supposed to do — mandatory under GxP, and worth doing as risk control everywhere else.
- GAMP 5 software categorization
- DQ / IQ / OQ / PQ document set
- Change control & periodic review
- Audit Trail, e-Signature per 21 CFR Part 11 and Annex 11
Factory digitalization & IT/OT infrastructure
Design the data architecture from equipment up to the management layer, then deploy the CMMS, OEE and ERP that run on it.
- ISA-95 architecture: SCADA, EMS, BMS, MES
- IT/OT integration, Edge & Store-and-Forward
- In-house CMMS, OEE, ERP — site-specific needs fixed at the source
- Predictive maintenance on real operating data
Segments Served
The areas that recur across every regulated industry
Five different industries still share the same problems: controlled areas, cold chain, utilities, electronic records and inspections.
Certifications & Achievements
Numbers you can verify
Nothing here asks you to take my word for it — the systems open in a browser, the articles are readable, the standards are public.
Insights
Latest articles
Articles grounded in each industry's primary standards — EU-GMP, FSSC 22000, SEMI E10, port MMBF, airport AHM — not recycled vendor marketing.
CMMS for Airport Ground Equipment — From GSE to Passenger Boarding Bridges
A passenger boarding bridge keeps serving flights right after a software update, with no post-upgrade safety check on file. This is exactly the kind of gap ground-equipment CMMS at an airport has to block.
Read moreERP for Airport Turnaround — When GSE Maintenance Competes With the Flight Schedule
Pulling a tug for maintenance right when its station is handling a tight-turnaround flight can extend a delay. Simulation research at Luton Airport shows GSE scheduling order directly affects turnaround delay.
Read moreOEE for Airport Ground Equipment — When the Standard Doesn't Exist
No aviation standard defines OEE for tugs, belt loaders, or ground power units. This isn't a research gap — it's simply the fact, and understanding it correctly matters more than searching for a standard that doesn't exist.
Read moreAbout
Nguyen Hai Dang — Operations Digital Transformation Advisor
For seven years I have worked in the middle layer of the plant: where equipment data reaches the management level. I started with SCADA, EMS, BMS and MES for substations and factories, then moved to building operations software myself after seeing that most problems sit not in the equipment but where data breaks between systems.
I do not resell vendor software. The CMMS, OEE and ERP systems I deploy are ones I built and that run in production — you can open the links yourself, and each plant's odd requirements get fixed at the source instead of waiting for a vendor patch.
See full profileBook a Consultation
Where is your plant stuck?
Describing the specific situation is enough to start. I respond within 24 business hours.
Direct contact
- dang.nguyen@esec.vn
- +84 933 759 921
- Zalo: +84933759921
- Ho Chi Minh, Vietnam