WORKING GUIDE FOR RA, QA AND DATA OWNERS
UDI Evidence Pack: bring submission evidence together traceably
Which data version was approved, what was transmitted — and what result came back?
A UDI Evidence Pack here means an organised collection of evidence for a UDI submission run. It connects the data version, checks, approval, transmission and available authority feedback. In this guide, the term refers to an organisational working aid from Europe IT, not a universally prescribed authority form.
The following structure helps you establish a traceable process. The evidence your organisation needs depends on the target market, system, quality management and agreed scope of services. A collection of files alone does not guarantee audit compliance.
Which evidence is generated when?
Use this matrix as a starting point for your internal checklist. “Available” means present in the system and process actually used — not automatically included in every software version or for every authority.
| Evidence | Content | Timing | Typical source / responsibility |
|---|---|---|---|
| Scope | Products, records, target authority and run type | Preparation | Responsible specialist team |
| Data version | Version, export date, filename; checksum where appropriate | Before checks and approval | Data owners |
| Review and approval | Reviewer, approver, timestamp, findings and decision | Before submission | Authorised specialist roles |
| Validation | Rule/software version used, report, errors, warnings and handling | Before submission | Validation process and customer |
| Submission | Run reference, user, timestamp and technical status | During transmission | Transmission process |
| Authority feedback | Available acknowledgements, content-related responses and results per record | After processing | Authority / customer team assessing results |
| Correction and resubmission | Cause, modified data version, renewed approval and link to the previous run | When feedback is received | Customer |
| Change/workflow evidence | Available history, audit trail extracts and process events | According to system and scope | System / process owner |
| Archiving | Storage location, access rights, retention policy and retrievability | Run completion and ongoing operations | Organisation / QMS |
Received does not automatically mean accepted on content. A technical receipt, transmission status and content-related authority response can describe different process stages. Retain the available feedback and document its meaning in the relevant authority process.
Where does the evidence come from?
GSP: upload and submission evidence
Associate the uploaded file, validation result, transmission and available authority feedback with the same transaction. Save provided reports and technical artefacts according to the module used.
A ZIP package can make filing easier if it is provided in the specific process. A screenshot supplements machine-readable results, but does not replace them. View the GSP process.
GUDI: data and workflow context in SAP
Link the UDI version, available approval and change history, and submission status. GUDI can retrieve and display authority feedback; the customer handles content corrections and resubmission.
A process event and a specific field change answer different evidence questions. Select the extracts appropriate to your scope. View GUDI data management.
Excel and XML projects
Excel is the data foundation, not proof of transmission. Record the original version, review, changes and approval. Add evidence from the subsequent conversion or submission.
In the manual EUDAMED XML process, source data, generated files, upload mapping and available results belong together. Compare transmission methods.
Define retention separately: Decide when results are saved from the system, who may access them and how long records are needed. This guide sets no blanket retention period and does not promise unlimited availability in the portal.
A six-step SOP structure
Define the data version
Identify the scope and version. Do not overwrite the original or later corrected version.
Perform the review
Check completeness and plausibility; record findings and how they were handled.
Approve
Document the authorised role, timestamp and approved version traceably.
Transmit
Execute the selected method; link the run reference, timestamp and status.
Interpret the result
Assess feedback. Do not merge successful and failed records into an unclear overall status.
Consolidate and archive
Link related evidence; check access, backup and retrievability.
An example of controlled filing
Illustrative organisational example, not a generated download or a requirement for your document control:
SUB-2026-0042/ 01_Scope-and-Data-Version 02_Review-and-Approval 03_Validation 04_Submission 05_Authority-Feedback 06_Correction-and-Resubmission 07_Closure-and-Archive-Reference
If useful, use a naming scheme such as AUTHORITY_SCOPE_YYYY-MM-DD_vX.xlsx. An SRN is only useful where it belongs in the authority context. A checksum can support matching; it replaces neither approval nor access control.
Review questions for RA and QA
Where does the data come from?
A responsibility matrix shows which fields come from ERP, labelling, development or quality management. Conflicting information requires a defined authoritative source and a resolution process.
How can corrections be traced?
Connect the message, cause, changed fields, checks and resubmission. Your QMS assessment determines whether an error triggers a formal CAPA process; not every returned record automatically constitutes a CAPA. Classify EUDAMED errors systematically.
Can I organise evidence using Excel?
Yes, as part of a controlled process. Versioning, review, permissions and external submission results must work together. The file format alone makes filing neither suitable nor unsuitable for audits.
Does Europe IT always automatically generate a complete Evidence Pack?
This guide describes a recommended evidence structure. The exports, reports and filing services actually provided must be checked against the relevant product and agreed process.
From individual files to a traceable process
Europe IT helps you assess data preparation and transmission. Bring your current workflow and required evidence — this makes it possible to clarify where system features are sufficient and where organisational rules are missing.
Discuss your UDI submission process · Structured Excel data preparation · Back to the UDI guide
Editorial status: 4 September 2026. Organisational aid based on the Europe IT process description; no audit or compliance guarantee.
