The ACUTA Validator (AV) is designed to validate electronic Common Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS) standards-based submissions, to ensure they are in compliance with Regional and ICH specifications and requirements. Using AV to verify submissions prior to submitting to the concerned agency will significantly minimize the risk of refuse to file or rejection from the agencies due to technical issues.
AV allows users to validate regulatory submissions to assure technical compliance based on the specifications and validation criteria published by the regional authorities and ICH.
AV produces a comprehensive report at the end of each validation, clearly showing valid and invalid results along with details as specified by the regional agencies.
By default, AV uses standard settings based on each region or country along with the DTD version of the submission. It also allows a user the flexibility to validate selected module(s) and/or only required set of criteria (e.g. criteria related to PDF files only).
AV only verifies and reports findings and does not modify submission content in any way. AV is available as a stand-alone Desktop application as well as a server-based application.
The licensing model includes an annual subscription as well as perpetual licensing.