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.mdskills/concept2cure/submission-readiness-review/SKILL.md
GitHubSubmission-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
- Locate:
c2c_list_submissions→c2c_list_sequencesfor the submission under review; note the sequence status (draft|assembling|validated|frozen|dispatched). - Assess:
c2c_assess_sequence_readinesswith thesequence_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,revokedorundetermined(undetermined is not unsigned; it means the lookup could not decide);freezeGateanddispatchGate—clearedplusblockers[].
- Structure check:
c2c_validate_ectd_structurewith thesequence_idfor the section-level detail behind the structural findings. - Portfolio context (optional):
c2c_readiness_overviewfor the organisation-wide rollup andc2c_search_precedentsfor the precedent slice (report an empty corpus as empty). - 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.urlthe tools return.