Validation Reports

Validation Reports for eCTD submissions give sponsors an overarching view of the technical errors present in a single sequence or an entire application. Contents of these reports should be consulted prior to filing an application with a regulatory authority. Validation Reports are critical to the quality review process and allow sponsors to ultimately submit a high-quality output.

Validation reports for eCTD submissions

VALIDATE allows GlobalSubmit users to generate Sequence and Application reports. Knowing what information is available in those reports and how to locate it makes them considerably more useful.

The Sequence report contains a complete list of errors, error severity levels, and the location of each error relative to your submission.

The Application report contains a snapshot of the application, metadata details, and a total count of error instances in each sequence.

Once the errors requiring correction are addressed in the publishing process, validation reports can be rerun for verification purposes.