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ROSETTA sceptre: eCTD validate
The Rosetta Stone

ROSETTA sceptre: eCTD validate
eCTD Validator eCTD Software

ROSETTA sceptre automates the crucial and tedious process of verifying eCTD submissions.

It makes sure submissions are compliant with ICH and regional eCTD specifications, guidance, and industry best practices. The eCTD standard is evolving. The current specifications are written in ways subject to different interpretations. ROSETTA sceptre is designed with this in mind. It provides comprehensive user-configurable validation rules. You can even save customized selections of validation rules as named rule sets for easy recall. And, you can run validation at any level; on a leaf document, section, module, submission or the entire lifecycle of an application. ROSETTA sceptre Enterprise Edition offers semantic validation which validates sponsor-provided attribute values, such as product names or study numbers, against authoritative sources in your organization. 

eCTD Products Validate eCTD Submisssions
 
eCT validation ICH eCTD specifications

Functionality Overview

  • Comprehensive and configurable validation rules
  • Supports more than 100 ICH and regional validation rules, including complete ICH Q&A No. 36 validation rule set.
  • Save customized validation rules as named rule sets for easy recall
  • Run validation at any level – on a leaf document, section, module, sequence or the entire lifecycle of an application
  • Detailed reporting. Rule violations can be exported as Rich Text Format (.rtf ) or plain text file (.csv) which can be opened by Microsoft Word or Excel, respectively.
  • Semantic validation (Enterprise edition only): Validate sponsor-provided attribute values, such as product names or study numbers, against authoritative sources in the enterprise
  • Automatically fix certain errors. E.g. Remove orphaned files and empty sections; Update checksums in the backbone files.
eCTD Lifecycle eCTD Product
ROSETTA eCTD     phoenix: eCTD View     sceptre: eCTD Validate     scribe: eCTD Publish     pyramid: eCTD Archive