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

Read-and-understand training tied to the exact document version that's effective.

ISO 13485 §6.2 (21 CFR Part 820, QMSR)
What it does

Assign a document's Effective version to trainees; each person completes an e-signed "read and understood" acknowledgment bound to that version. A training matrix flags who is not current on the documents their role requires.

How Indelio handles it

The acknowledgment is a password-re-authenticated electronic signature bound to the effective version's content hash. When a newer version goes Effective, prior completions are flagged as superseded — a clear, automatic retraining signal.

Key capabilities
  • Role-based training matrix with gap detection
  • E-signed read-and-understand acknowledgments
  • Automatic retraining flags on new document versions
The whole quality system shares one audit trail.
Training 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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