Part 11 by design
Designed around the requirements of 21 CFR Part 11, ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR), following a GAMP 5 risk-based approach.
Industry product · Life sciences
Indelio: quality management for small medical-device and biotech companies.
Indelio is an AI-assisted electronic quality management system (eQMS) for small medical-device and biotech companies. It brings controlled documents, CAPA, complaints, risk, training, audits and suppliers into one platform, with two-component electronic signatures and a tamper-evident, hash-chained audit trail. The AI drafts and suggests; a person always reviews and signs.
Why we built it.
Quality teams at small device and biotech companies run the same controls as large ones, often with one or two people and a stack of spreadsheets. Indelio puts the whole system in one place and uses AI for the slow parts, while people stay the reviewers and signers.
What it covers.
Connected modules with one audit trail.
- Document Control
- Change Control
- Customer Complaints
- Post-Market Surveillance
- CAPA
- Nonconformances
- Design Controls
- Human Factors (HFE/UE)
- Risk Management
- Training
- Supplier Qualification
- Calibration & Maintenance
- Audits
- Projects & Validation
- Management Review
- Corrections & Removals
- Quality Policy & Objectives
How it's built.
The AI drafts, a person signs
The AI drafts and suggests; a person always reviews its output, and approvals are made with that person's electronic signature.
Validation package included
Every plan includes a validation package: validation plan, requirements specification, Part 11 traceability, IQ and PQ protocols, and an automated test suite.
What it shows about how we work.
The same habits behind our logistics work: build for one industry's real rules, keep people in charge of anything that matters, and make every action traceable.
Regulatory references describe how the software is designed. For plans and pricing, see indelio.io/pricing.
FAQ
Questions, answered.
Is Indelio part of Voxelio?
Yes. It's a Voxelio product with its own site, indelio.io.
Who is it for?
Small medical-device and biotech companies.
Does the AI approve records?
No. The AI drafts and suggests; a person reviews its output, and approvals are made with that person's electronic signature.
What regulations is it designed around?
21 CFR Part 11, ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR), following a GAMP 5 risk-based approach.
Where can I see it or check pricing?
Try the interactive demo or see plans on indelio.io.
What about security and data hosting?
Security and privacy details are published on indelio.io.