LOTO safety guides
Lockout/Tagout, UNI EN 17975:2025 and control of hazardous energy in maintenance.
Resources
Technical knowledge, not filler content.
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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7 min ACCREDIA-accredited calibration and on-site calibration in pharma
What ACCREDIA-accredited calibration means, when a LAT centre is needed and how on-site calibration of critical instrumentation works in a GMP site, with documented traceability.
7 min Annex 15 requirements for the qualification of equipment
What Annex 15 of the EU GMP requires for the qualification of equipment, plants and utilities: VMP, URS, phased DQ/IQ/OQ/PQ approach, requalification and change control.
7 min Who can perform the qualification of a GMP instrument (and how much it costs)
Who can perform the IQ/OQ/PQ qualification of instruments and equipment in a GMP context, what to ask a qualification service provider in Italy and what the cost depends on.
6 min The difference between calibration and qualification of an instrument
Calibration and qualification are not synonyms: the first guarantees the accuracy of the measurement, the second demonstrates that the instrument is fit for use. How they integrate in GMP.
Pillar IQ/OQ/PQ qualification of a GMP instrument: a practical guide to DQ, IQ, OQ, PQ
How to qualify a GMP instrument or piece of equipment: DQ, IQ, OQ, PQ protocols according to GAMP5 and Annex 15, who performs it and what is needed for the audit.
6 min Thermal requalification of chambers, autoclaves and temperature-controlled environments
What thermal requalification (thermal mapping) is, when it must be redone and how it is performed on climatic chambers, autoclaves and GMP warehouses: probes, distribution and heat penetration.
8 min Lockout/Tagout solutions supplier in Italy: how to choose
What a complete LOTO solution really includes and how to choose a supplier for a pharmaceutical GMP context: regulatory competence, alignment with UNI EN 17975:2025 and ALCOA+ traceability.
8 min LOTO management software: what it must do and its GMP requirements
What a LOTO management software does: isolation-point register, parent/child sequences, selective release, non-disableable audit trail and GMP requirements (Annex 11, 21 CFR Part 11, GAMP5).
Pillar Instrument calibration in GMP: a practical guide to metrological management
How to manage calibration in GMP: critical instruments, traceability, intervals, Out of Tolerance, audit trail and data integrity.
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
Criteria for setting and reviewing calibration intervals: criticality, drift, use conditions, history, OOT events and documented justification.
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
Official INAIL data and recurring maintenance-accident dynamics: unexpected start-up, residual energy and isolation errors.
7 min Paper or digital LOTO: what changes for a GMP audit
Paper and digital records can both support LOTO. The comparison concerns traceability, contemporaneous records, audit trails and GxP system requirements.
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
What UNI EN 17975:2025 requires for LOTO: isolation processes, Try-Out, roles, traceability and a practical maintenance checklist.