Indelio
AI-native quality management · 21 CFR Part 11 / GAMP 5
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Projects & Validation

Project and validation workspaces for URS, IQ, OQ, and PQ.

GAMP 5 · ISO 13485 §7.5, §7.5.6 (21 CFR Part 820, QMSR)
What it does

Run projects and validation efforts as workspaces with typed deliverables — URS, IQ, OQ, PQ, protocols, reports, and tasks. Track each deliverable to completion before the project itself can be signed complete.

How Indelio handles it

The project-completion electronic signature requires every deliverable to be complete and binds the project's fields and deliverable states. Everything is recorded on the shared immutable audit trail.

Key capabilities
  • Typed validation deliverables (URS / IQ / OQ / PQ / protocol / report)
  • Completion gated on all deliverables done
  • E-signed project completion
The whole quality system shares one audit trail.
Projects & Validation 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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