Gatekeeper™ is a validation module, providing the capability to receive, validate and archive eCTD submissions. This is an integral part of the eCTD review process and allows sponsor organizations to mimic the agency review environment for their own QA/QC process before the submission is shipped to the agency.

Features: 

• ICH (aka Q36) and regional agency recommended validation criteria  
• Ability to validate ICH and regional XML backbone
• Ability to validate eCTD Directory structure and checksum
• Detailed reporting capability
• Load submission to Review area and update review database
• Capability to add/remove validation criteria
• Criteria to validate PDF Fast Web View requirement
• Criteria to validate PDF  hypertext links and bookmarks
• Check for security of PDF and MS word files

This is a add-on module in our eCTDViewer application.