Category: Validator

ACUTA, ARIM, ARIM Publisher, eCTD, FDA, Uncategorized, Validator

FDA Validation Criteria to change July 27

On June 21, FDA announced changes to their eCTD validation criteria, to be implemented on July 27. The first is to remove a low-severity item, #5025, which would highlight the lack of PDF-fillable forms. The rest are a set of new validation rules, numbered 1-7, that were previously part of their Submission Acceptance criteria — …

ACUTA, ARIM, Australia, eCTD, Validator

ACUTA Validator now listed by the Australian agency

In November of 2017, we reported the details of Australia’s updated guidance for version 3.1 of their regional eCTD specifications. ARIM Suite Version 3.2, which was released shortly after that, provided full support for publishing and validating Australian submissions. While ACUTA Validator has been capable of accurately validating submissions to Australia’s Therapeutic Goods Administration (TGA) …

ACUTA, ARCS, ARIM, ARIM Publisher, FDA, Software Release, Validator

Getting your STF in order

In 2003, ICH introduced the Study Tagging File (STF) in the electronic Common Technical Document (eCTD) format for electronic submissions to facilitate a way to associate all the documents and data files for a study. Initially the specification included two possible approaches for versioning the study’s items: Cumulative: A complete cumulative STF would be provided …

ACUTA, ARIM, Australia, Canada, eCTD, South Africa, Validator

ARIM 2.3.3 hotfix 11 and ARIM Validator 3.2 Released: Canada, Australia, South Africa updates

ACUTA has released new versions of ARIM 2.3.3 Hotfix 11 and ARIM Validator 3.2 (desktop). The primary features included in this release are: Support for South Africa (ZA) Validation specifications v2.1 Support for Australia (AU) v3.1 Validation and eCTD specifications. Support for Canada (CA) Validation specifications v4.2 Other cool enhancements: The license key can now …