Safety & LOTO
Lockout/Tagout, UNI EN 17975:2025 and control of hazardous energy in maintenance.
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Guides and technical insights on compliance, metrology and safety, organized by area of expertise. Written by people who know regulated environments from the inside.
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Pillar Instrument calibration in GMP: a practical guide to metrological management
How to organize a GMP-compliant calibration system: traceability, intervals, Out of Tolerance, audit trail, data integrity. Industrial metrology for those operating in a regulated pharmaceutical environment.
7 min Data integrity in calibration records: ALCOA+ and Annex 11 in practice
Calibration records are GxP data in every respect and must comply with the ALCOA+ principles. What this means in practice for those managing the metrology of a GMP site, with or without digital support.
6 min Calibration interval: how to define it, justify it and let it evolve
The calibration interval is not a fixed value chosen once and for all. It is a risk-based decision that must be justified, reviewed and adapted to the instrument's historical data.
7 min Out of Tolerance: how to manage the impact on batches already released
A critical instrument out of tolerance at the periodic calibration is not just an instrument problem: it is a potential retroactive deviation. How to conduct the impact assessment according to GMP.
7 min Maintenance accidents: what the INAIL data say and the recurring dynamics
The official figures on workplace accidents in Italy and the typical dynamics documented in the technical literature for maintenance activities. Read through the lens of UNI EN 17975:2025.
7 min Paper or digital LOTO: what changes for a GMP audit
The audit trail required by UNI EN 17975:2025 intersects the data integrity requirements of Annex 11. What a GMP inspector asks about LOTO procedures and what makes the difference between paper and a digital system.
7 min Parent/child lockout: how to manage hierarchical isolations on complex plants
On real plants with dozens of isolation points, LOTO becomes a question of hierarchy. How to manage parent/child dependencies according to UNI EN 17975:2025.
6 min Reinforced isolation, standard or neutralization: how to choose the LOTO process
UNI EN 17975:2025 defines four isolation processes. Practical criteria for deciding when to apply RI, SI, N or SP and how to document the choice.
Pillar UNI EN 17975:2025 — a practical guide to Lockout/Tagout in maintenance
The first European standard on LOTO imposes a method for isolating energies and fluids during maintenance. What changes, how to comply, when reinforced isolation applies.