UDI Guide: EUDAMED Submission, Data Quality & Audit Evidence
This guide is aimed at Regulatory Affairs & Quality (RA/QA), who need to reliably prepare, submit and audit-proof UDI data – without unnecessary loops. Here you will find three tried-and-tested guides: Decision support (which path fits?), error library (reduce returns) and evidence pack (standardize evidence).
Quick start: If you only have 5 minutes today, start with the decision aid and then go to Error Library or Evidence Pack as needed.
What you’ll get in this guide
- Clear process: From data collection to validation, submission and evidence.
- RA/QA-focused: Less technical language, more handles, responsibilities and review logic.
- Reusable: checklists, SOP logic and standard templates (e.g. evidence pack per run).
The 3 Core Guides
1) Decision support
Which path suits your team? Excel template, submission portal or SAP add-on – with comparison table and project plan.
2) Error library
Top Returns as Symptom → Cause → Fix → Prevention. Ideal for speeding up corrections and eliminating repetitive errors.
3) Evidence Pack
What evidence auditors typically expect – and how to standardize and archive evidence per submission run.
Recommended order (depending on the situation)
If you’re just getting started
- Decision support (scope, roles, select path)
- Error library (data quality & return prevention)
- Evidence Pack (Evidence & SOP)
If you already have bounces
- Error Library (Classify & Schedule Fix)
- Evidence pack (correction + re-submission audit-proof storage)
When an audit is imminent
- Evidence Pack (Minimum Ingredients + Archiving)
- Error library (CAPA-capable return processing)
Appropriate solutions (if you want to go from “knowledge” to “operation”)
The guide is deliberately written in a solution-neutral way. If you then want to set up the operational process, these are your three typical entrances:
- MDR/IVDR Excel Template – structured data collection & review basis
- Global Submission Portal – Validation, Submission, Status & Evidence (SAP independent)
- Global UDI SAP Add-on – Governance, Roles, Releases & Audit Trail in SAP Context
FAQ
Who is the UDI Advisor for?
For RA/QA teams that need to prepare, submit and audit-proof documentation of UDI data – regardless of whether the database comes from Excel or SAP.
What’s the quickest way to get started?
Start with the decision support. After that, you either go to the error library (returns/data quality) or to the evidence pack guide (audit/evidence).
Can I work with Excel audit-proof?
Yes – if you use versioning, controlled filing, review log and a change process. For status/submission proofs, you also need a submission process (portal or SAP add-on).
