Indelio
AI-native quality management · 21 CFR Part 11 / GAMP 5
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Supplier Qualification

Qualify suppliers, keep an approved-supplier list, and re-evaluate on schedule.

ISO 13485 §7.4 (21 CFR Part 820, QMSR)
What it does

Move suppliers through qualification (Pending → Under Evaluation → Approved → On Hold / Disqualified), maintain a live approved-supplier list, and track periodic re-evaluation so approvals don't silently go stale.

How Indelio handles it

Supplier approval, holds and disqualification are electronic-signature events that bind the evaluation. Approval sets the next re-evaluation date automatically, and the list flags overdue re-evaluations. A hold takes a supplier off the approved list while a problem is investigated, without discarding the qualification. Supplier audits feed the supplier file.

Key capabilities
  • Approved-supplier list with overdue re-evaluation flags
  • E-signed approval, hold, and disqualification
  • Reversible On Hold — off the approved list, qualification kept
  • Linkage to supplier audits
The whole quality system shares one audit trail.
Supplier Qualification plus thirteen more modules — connected, Part 11, validation included.
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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
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