Monitoring data is only useful as evidence if it can be trusted. Regulators assess this through data integrity: is the record complete, accurate and protected from undetected change?

ALCOA+ applied to monitoring

  • Attributable: every change and acknowledgement is linked to a named user.
  • Legible and original: raw measurements are kept, not only summaries.
  • Contemporaneous: data is recorded when it is measured, with reliable time stamps.
  • Accurate: sensors are calibrated and traceable.
  • Complete, consistent, enduring, available: no gaps, no silent edits, retained for the required period and retrievable for inspection.

What inspectors typically ask

  • Show the audit trail for limit changes on this freezer.
  • Show all alarms in this period and how each was handled.
  • Explain this gap in the data.
  • Show the calibration status of this sensor at the time.
  • Show how user access is controlled.

Common weak points

Gaps caused by network outages, shared user accounts, limits changed without record, data exported to spreadsheets and edited, and calibration offsets applied without documentation.

Design principles

Local buffering to prevent gaps, individual user accounts with role-based rights, a tamper-evident audit trail, electronic signatures where required, validated software, and secure hosting under an information security management system such as ISO 27001.

How XiltriX Resilience fits

XiltriX Resilience is an Operational Resilience System built on three layers:
  • Infrastructure: independent sensors and monitoring stations with battery support, resilient connectivity and local data buffering, so a power or network interruption does not create a gap in the record.
  • Intelligence: validated software that turns measurements into alarms, escalation, trends, reports and audit-ready evidence.
  • Care: installation, validation, calibration, preventive maintenance and 24/7 technical support for the monitoring system, delivered by one partner that is ISO 9001 and ISO 27001 certified.

Who does what when an alarm fires

XiltriX Intelligence applies the limits, delays and escalation sequence agreed with the customer, and keeps escalating through the customer's contacts until someone acknowledges. The customer's own team assesses the situation and carries out the physical response.
XiltriX does not respond to the customer's alarms. XiltriX Care provides 24/7 technical support when the monitoring system itself has a problem.

Where to go next

Read validation and calibration and data logger vs EMS.