DRAFT - pre-regulatory package generated by PHAXTON.

This is a PREPARATORY tool for regulatory submissions. It checks and prepares materials BEFORE submission; it does not submit to, and is not endorsed, certified or validated by, any regulatory agency (FDA, EMA or other). Outputs are drafts for review by qualified professionals; acceptance of any submission is not guaranteed. The user (sponsor/applicant) retains sole responsibility for the content, accuracy and regulatory compliance of any submission. Automated repairs are applied only to copies, with a logged list of changes; originals are never modified. Provided "AS IS", without warranty of any kind. Not an electronic records/signatures system under 21 CFR Part 11.

It is not signed or transmitted, and CSR-ready and Part 11 are claims the product does not make.
It requires human review and signature; submission is done by a publisher.
CDISC CORE: CORE sdtmig 3-2: ran 123 of 180 applicable rules (114 pass, 9 fail); 57 did NOT run | adamig 1-1: the CORE rules cache has no rules for adamig 1-1 (rules_dictionary.pkl: 0): these datasets have NO CORE coverage; CORE was not started for this group (cache pre-check). Groups with 0 rules run have no evidence.
ADPP (ADaM, PK parameters): issued, PARTIAL; checked against the PP and ADNCA read back (128 checks); 382 of 388 CT codes without a row (MISSING); ADPC carries the same values (kept for compatibility)
ADNCA (ADaM, NCA input): issued, PARTIAL (see audit/audit.json: rules, limits, structure inspired by the IG)
Status per piece and declared debt: audit/audit.json
