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Audits
Internal and supplier audits with findings that drive CAPAs.
ISO 13485 §8.2.4 (21 CFR Part 820, QMSR)
What it does
Plan and run internal, supplier, regulatory, and certification audits as a parent audit with child findings (classified major/minor/observation). Findings link to CAPAs, and supplier audits feed the supplier file.
How Indelio handles it
A controlled lifecycle (Planned → In Progress → Report Issued → Closed) with e-signatures at report issuance and closure, and segregation of duties between the two. Closure is blocked while any major or minor finding remains open — so audits can't be closed with loose ends.
Key capabilities
- ✓ Finding classification and follow-up tracking
- ✓ Findings link directly to CAPAs
- ✓ Closure gated on open findings
The whole quality system shares one audit trail.
Audits plus thirteen more modules — connected, Part 11, validation included.
Explore the rest of the suite