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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.
Explore the rest of the suite