Indelio
AI-native quality management · 21 CFR Part 11 / GAMP 5
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Indelio
For the people who own the audit

Built for quality managers — and shaped by them.

Your entire quality system in one AI-native platform — controlled documents, CAPA, audits, risk, training and suppliers, with two-component e-signatures and an immutable, hash-chained audit trail. Designed around how quality actually gets run at a device or biotech team too small for Veeva, and refined with feedback from practicing medical-device quality and regulatory professionals. Live in days, validation included.

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21 CFR Part 11GAMP 5ISO 13485Immutable audit trailRole-based access + MFADatabase-enforced data isolation
indelio.io/doc/SOP-001
SOP-001 · Cleaning ValidationEffectivev1.0
E-signatures
Reviewed byBen Carter2026-05-07 14:22 UTC✓ intact · a3f91c
Approved byJordan Avery2026-05-07 15:04 UTC✓ intact · b7c204
Audit trail · append-only, hash-chained
#Time (UTC)ActorActionHash
12026-05-07 14:05Maria LopezCREATE_DOCUMENT9f2a1d
22026-05-07 14:10Maria LopezSUBMIT_FOR_REVIEWc14b77
32026-05-07 14:22Ben CarterSIGN_REVIEWa3f91c
42026-05-07 15:04Jordan AverySIGN_APPROVALb7c204
52026-05-07 15:04Jordan AveryMAKE_EFFECTIVEe88d30

Every signature and change on one tamper-evident, hash-chained audit trail.

Seventeen modules. One audit trail.

A connected quality system, not seventeen disconnected tools — audit findings open CAPAs, supplier audits feed the supplier file, document updates flag retraining. Click any module to see how it works.

Why teams switch to us

AI-native
Draft SOPs, redline against the regs, and migrate your legacy documents with AI — injection-safe, and never the final approver. A human signs every record.
Part 11 by design
Two-component e-signatures and segregation of duties enforced server-side, and a tamper-evident, hash-chained audit trail enforced in the database — not bolted on.
Validation included
Every plan comes with the validation package — Validation Plan, System Requirements Spec, Part 11 traceability, IQ and PQ protocols, and 1,900+ automated tests. You execute it against your own instance; we support you through it. No $20–50k implementation invoice.
No lock-in
Published pricing, month-to-month if you want it, and you're live in days — not a 3–9 month rollout on a multi-year contract.

Already have your SOPs in Google Drive or SharePoint?

Bring them with you. Bulk migration takes your existing PDF, Word and PowerPoint documents into controlled Document Control — with their history intact, and without re-approving your whole library one document at a time.

STEP 1
Upload in bulk
Drop in your existing PDF, Word and PowerPoint SOPs and training decks — a whole library at once, not one at a time.
STEP 2
AI proposes, you confirm
Each file is read and its document code, title, type, version, effective date and legacy approver are proposed. You correct anything wrong before it counts.
STEP 3
One signature, not hundreds
Your QA signs a single batch verification bound to a hash of exactly which files were accepted — instead of re-approving every document.

We never forge a signature on a document someone else approved. Each migrated version is marked as migrated and carries the legacy approval it actually had — so an auditor can see exactly what came across, who approved it originally, and who verified the batch.

Simple, published pricing from $9,900/year.
Validation included. Published pricing. No multi-year lock-in.
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An evaluation environment — not yet a validated production system. Validation IQ/OQ/PQ available.