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
  • ✓ Nonconformances naming the supplier on its record, open counts on the Approved Supplier List, and unanswered recommendations flagged
The whole quality system shares one audit trail.
Supplier Qualification plus thirteen more modules — connected, Part 11, validation package 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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