Indelio
AI-native quality management · 21 CFR Part 11 / GAMP 5
Start free trialSign in
← Indelio
🔧

Calibration & Maintenance

Keep monitoring and measuring equipment calibrated, and prove it.

ISO 13485 §7.6 · 21 CFR 820.72 (21 CFR Part 820, QMSR)
What it does

A register of the instruments and equipment your quality decisions rest on — each with its calibration interval, the standard it is traceable to, its accuracy limits, and any preventive-maintenance schedule. Calibration, maintenance and repair records live against the item, with the certificate attached, and due and overdue dates surface in reminders.

How Indelio handles it

A record is entered by whoever received the work and accepted by a second person holding the approver or qa role — only that acceptance moves the equipment's calibration status. An out-of-tolerance result takes the instrument out of service and cannot be accepted until the effect on previous measurements is assessed and recorded, with the suspect window back to the last passing calibration stamped on the record. The instrument returns to service only on a later passing calibration.

Key capabilities
  • Calibration and PM due dates, with overdue and unscheduled both flagged
  • Out-of-tolerance handling that reaches back over previous measurements
  • E-signed acceptance by a second person, with the certificate attached
The whole quality system shares one audit trail.
Calibration & Maintenance plus thirteen more modules — connected, Part 11, validation included.
Start free trialSee pricing
Explore the rest of the suite
📄Document ControlControlled lifecycle, e-sign, controlled PDF🔁Change ControlImpact assessment + approval📣Customer ComplaintsIntake, investigation, MDR decision📈Post-Market SurveillanceTrend detection across complaints & nonconformances
Security & Compliance·FAQ·Pricing