eCTD Guidelines

Manually compiling documents that are generated from myriad sources and systems (i.e., PLM, ERP, etc.) is an inefficient and painstaking process that ultimately leads to delayed submissions.

Deadlines are missed because managing timelines and tracking requirements for all countries in which registration is sought can be an impossible task when using spreadsheets that don’t scale to the complexities required by CTD guidelines.

Keeping pace with the granularity of every registration is overwhelming as the variables in eCTD guideline requirements increase exponentially relative to the number of countries and number of products being registered.

The use of disparate systems leads to communication breakdowns and an inability to provide timely response to issues relating to eCTD guidelines.

Filings can be inconsistent when different teams are focused on customizing registrations to each market, causing submission data to be fragmented across multiple systems.

When multiple products need to be registered in many countries, it is easy to become mired in minutiae and lose visibility into eCTD-guideline-critical activities and deadlines.

Preconfigured Templates

MasterControl’s building-block templates are based on eCTD guidelines to help companies launch their registration projects fast. The Registration Template provides an indispensable structure regardless of regulatory or regional variables and includes a tool for customizing discrete processes into standardized templates for every country. A notification Template provides a framework for notifying various departments and stakeholders about tasks or approaching deadlines.

Checklists

This basic safety mechanism to help avoid eCTD guideline requirements from being overlooked and tasks from falling through the cracks can be customized based on country.

Easy-to-use Explorer Tool

MasterControl allows users to organize, find, and access documents quickly and create shortcuts to frequently used documents and readily view metadata and native files.

InfoCards

These fundamental tools for creating, searching, and retrieving documents serve as placeholders for documents in the database so they can be readily identified and summarized.

Dashboard

This robust tool consolidates charts to provide users with a view of a lot of data in on one consolidated page.

Reporting and Analytics

MasterControl’s metrics capabilities allow users to generate both standard and custom reports that can be drilled down according to your business needs.