This is a ready-to-use checklist to run before an eCTD sequence is transmitted to a health authority gateway. It covers leaf-level quality control and validation-finding triage, and sets the release gate most organizations hold to: zero unresolved high-severity findings. Replace every <<FILL: ...>> placeholder. This content is educational reference, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Application / sequence | <<FILL>> |
| Region / gateway | <<FILL>> |
| Validation tool and version | <<FILL>> |
| Completed by | <<FILL>> |
| Date | <<FILL>> |
Section A, Leaf-level QC
| # | Item | P/F/NA | Evidence |
|---|---|---|---|
| A1 | Every leaf opens, prints, and contains searchable text where text is expected (not a flat scanned image) | <<FILL>> | <<FILL>> |
| A2 | Bookmarks reach the expected granularity and every internal and cross-document hyperlink resolves | <<FILL>> | |
| A3 | Every leaf checksum recorded in the backbone matches the actual file | <<FILL>> | |
| A4 | Every leaf sits under the correct CTD heading with a specification-compliant title | <<FILL>> | |
| A5 | No orphan files exist outside the backbone, and no file referenced in the backbone is missing | <<FILL>> | |
| A6 | Every leaf was rendered from the current, approved, signed source document, not a draft | <<FILL>> |
Section B, Lifecycle operation QC
| # | Item | P/F/NA | Evidence |
|---|---|---|---|
| B1 | Every replace operation references the correct specific prior leaf, verified against the current view | <<FILL>> | <<FILL>> |
| B2 | No leaf that should replace prior content was filed as new, leaving two contradictory current documents | <<FILL>> | |
| B3 | Every delete operation removes the intended leaf and no other | <<FILL>> | |
| B4 | The submission type and regional metadata (application number, sequence type) are correct and consistent across every file | <<FILL>> |
Section C, Validation finding triage
List every validation finding, its severity, and its disposition. No sequence is released with an open high-severity finding.
| Finding | Severity (High/Medium/Low) | Disposition | Closed by / date |
|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL: fixed / justified and accepted>> | <<FILL>> |
Section D, Gateway
| # | Item | P/F/NA | Evidence |
|---|---|---|---|
| D1 | The sequence was transmitted to the correct gateway for the region and application | <<FILL>> | <<FILL>> |
| D2 | A positive final acknowledgment was received and retained as a record | <<FILL>> | |
| D3 | If a negative or missing acknowledgment occurred, the cause was identified and the sequence retransmitted | <<FILL>> |
Acceptance criteria
- Every Section A and B item is Pass or a justified N/A before validation is run.
- Zero unresolved high-severity validation findings before transmission.
- Every Medium/Low finding carries a documented fix or a documented justification for accepting it as-is.
- A positive gateway acknowledgment is retained; a negative or missing one is investigated and resolved before the sequence is considered filed.
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Regulatory operations / publisher | <<FILL>> | ||
| Quality assurance | <<FILL>> |
References
ICH M8, Electronic Common Technical Document (eCTD) Implementation Guide. FDA eCTD Technical Conformance Guide and Specification for eCTD Validation Criteria (current version). EU eCTD Validation Criteria (current version).
Confirm the current version of each reference before issue.
Filled specimen
A partial completed checklist with one real finding triaged. Illustrative only.
| Finding | Severity | Disposition | Closed by / date |
|---|---|---|---|
Leaf at 3.2.S.4.1 has replace operation but the referenced prior leaf ID was not found | High | Fixed: the specification had actually moved to a different heading in a prior sequence; the modified-file reference was corrected and the sequence rebuilt | R. Okafor, 12 Aug 2026 |
| Two bookmarks missing in a 400-page clinical study report | Low | Fixed before release; regenerated bookmarks from the document’s heading structure | R. Okafor, 12 Aug 2026 |
| One cross-document hyperlink from 2.7.3 to a Module 5 listing does not resolve | Medium | Fixed; the target file path had changed during rendering and the link was rebuilt | R. Okafor, 12 Aug 2026 |
All three findings were closed before transmission; none were shipped with an open high-severity item, which is the release gate this checklist exists to enforce.
Common inspection findings this checklist prevents
- A sequence is transmitted with a known high-severity validation finding still open, causing a gateway rejection or technical refuse-to-file.
- A
replaceoperation points at the wrong or a non-existent prior leaf, corrupting the current view. - No retained gateway acknowledgment exists to prove the sequence was actually received.
- A leaf was rendered from an uncontrolled or draft source that differs from the approved document.
How to adapt this checklist
- Set your application, sequence, and region in the header.
- Name your actual validation tool and confirm its current criteria version before each use.
- Add product- or region-specific QC items your organization has learned it needs.
- Confirm every regulation in the references against the current published version before issue.