submission-readiness-review

Submission-readiness review of an eCTD sequence or a portfolio — structural validation, required Module 1 coverage, shadow review, external validator posture, Part 11 release signature and the compose

SKILL.md

GitHub

Submission-readiness review

Readiness is a verdict the platform computes. Your job is to obtain it, explain it, and list the blockers in the order a team should clear them. You never originate a readiness score, a blocker count or a risk level.

The review, step by step

  1. Locate: c2c_list_submissions → c2c_list_sequences for the submission under review; note the sequence status (draft|assembling|validated|frozen|dispatched).
  2. Assess: c2c_assess_sequence_readiness with the sequence_id. Read:
    • readiness — structural findings (errors block; warnings and infos do not);
    • validationErrors, leafCount, required Module 1 coverage;
    • shadowReviewRunCount / shadowReviewMissing — a clear gate with no shadow review means "allowed, never reviewed"; say that;
    • externalValidation.configured / .ran — if no agency-grade validator ran, the sequence has not been validated to agency criteria; say that;
    • releaseSignature.verdict — unsigned, awaiting, valid, invalid, revoked or undetermined (undetermined is not unsigned; it means the lookup could not decide);
    • freezeGate and dispatchGate — cleared plus blockers[].
  3. Structure check: c2c_validate_ectd_structure with the sequence_id for the section-level detail behind the structural findings.
  4. Portfolio context (optional): c2c_readiness_overview for the organisation-wide rollup and c2c_search_precedents for the precedent slice (report an empty corpus as empty).
  5. Deployment posture (when the question is "can this environment file at all"): c2c_ga_readiness_probe — licensed DTDs, eSTAR templates and validator configuration, observed on disk.

The go/no-go summary format

Sequence <number> (<region>) — status <status>
Dispatch gate: CLEAR | BLOCKED
  Blockers (engine): 1. … 2. …
Freeze gate: CLEAR | BLOCKED
Structural: <errors> errors, <warnings> warnings, <present>/<required> required sections
Shadow review: <n> run(s) | none — gate clear but never reviewed
External validation: <validator> configured: yes/no; ran: yes/no
Release signature: <verdict> (<detail>)
Next actions (in order): …
Source: c2c_assess_sequence_readiness at <timestamp>; all figures verbatim.

Rules

  • Quote blockers exactly as the engine words them.
  • Do not soften a BLOCKED gate into "nearly ready".
  • If any tool refuses (wrong organisation, sequence not found, no licence), the review stops there and the refusal is the finding.
  • Filing, freezing and signing happen in Submission Center by a named person; point to the signOff.url the tools return.