eCTD Validator - eSubmission Technical Validation
The purpose of validation is to help ensure Sponsors provide valid electronic transactions and reduce follow-up times to Agency requests. Validation minimizes the possibility of rejection due to technical validation errors which can cause delays in the overall regulatory process.
Prior to filing your eCTD submissions to regulatory agencies you should make certain your sequences are technically valid.
All your usage scenarios are covered:
Mono eCTD Validator is a multi-regional eCTD validation solution packed with lots of powerful features to help you provide valid electronic submissions to regulatory agencies.
Validation Rules - Complexity Friendlified
Mono eCTD Validator was built with the ease of use in mind: the complex list of technical rules is presented in a user friendly manner. Rules are grouped by their category having each rule described with rule severity, description, comments and corrective actions on how to solve a possible problem.
Mono eCTD Validator streamlines the technical review process and ensures compliance with eCTD specifications, guidelines, best practices and regulatory requirements across ICH regions.
Mono eCTD Validator's fluent user interface hosts a rule tree and a set of tabbed panes to quickly preview regional metadata (envelopes / administrative info / transaction info), sequence summary and PDF validation reports.
Most recently validated sequences are kept for faster re-validation. Upon validation the validation summary and the complete validation report (along with partial report - including only rules that failed to met the validation criteria) in PDF format is generated.
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Mono eCTD Validator Features
Your eCTD Validation Solution
Even if you already have an eCTD validation tool: try Mono eCTD Validator to unleash all the potentials of eCTD compliance testing.
Make sure your submissions are not rejected by Regulatory Agencies!
Mono eCTD Validator is a CESP (Common European Submission Portal) approved validation tool.
Validation Rules Tree
The appropriate validation set is automatically detected and selected by Mono eCTD Validator. Each validation set defines a group of rules as specified by each regional Agency. Rules are defined by their severity (medium, high ... or pass/fail) and their descriptive text and comments and possible how-to-solve actions. The rule validation details tab lists additional entries related to documents that failed to meet the required criteria.
No time to waste time?
Nobody has seconds (or minutes) to spare. Mono eCTD Validator will unleash your machine processing power. During validation, multiple documents will be processed (validated) at the same time. Have your sequence validated in no time. A 4 GB submission validated in less than 4 seconds!
Your validated sequence at a glance. The Validation Summary provides your starting point to determining if a sequence is valid or not. What's more it lists supplementary data like additional sequences found, sequences referenced, missing sequences. Further: number of files, file types, validation version, ...
Validation Report: Complete
Upon validation, the complete validation report in PDF format, including results for all validation set rules, is generated. Readily save or print the validation report and send it to your Regulatory Agency or client.
Validation Report: Partial
If there are rules that failed to meet validation criteria, a partial report will also be generated including only the rules which did not succeed. Quickly scan and easily fix your submission.
Most Recently Validated
Keep the tabbed list of most recently validated sequences for faster re-validation. Decide what number of items to keep. Each tab hosts the regional image, product name and the sequence number - so you can easily locate the submission you need to re-validate.
Markup Annotations (/Comments)
Add markup style annotations to the generated validation report. Speed up your internal reviewing process using standard PDF commenting tools: highlight and sticky note. Add replies, set statuses and open in any PDF viewer.
PDF Hyperlink Explorer
PDF Hyperlink Explorer quickly scans and processes PDF documents and hyperlinks to present a clean and simple view of how your documents are cross-linked. Check for the type of the hyperlink (including link text, page, position), target documents, whether a document is optimized for Fast Web View, if PDF properties are valid (initial view magnification, initial view page layout, PDF version, etc.). Process any PDF collection - not only an eCTD/NeeS submission!
Use Submission Comparer to determine changes between two eCTD (/NeeS) sequences, pinpoint missing files, alternations in file size or differences in MD5 checksum between same named documents. Filter the compared display to show only the missing documents in the matching structure.