Regulatory Submissions: Filling the Critical Gaps in EDM Systems

Patricia Santos Serrao
The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

It's been said that electronic document management (EDM) systems for the management of submission documents are "a dime a dozen." However not all EDM systems are created equal, at least not when it comes to the management of final submission documents. Many of us are familiar with the standard functionality that most EDM systems provides particularly in the life sciences space such as: document types, taxonomy, version control, lifecycle management, securities, PDF rendering, watermarks, and electronic signatures just to name a few.

The combination of an EDM system and submission publishing tools provide a robust solution for regulatory affairs submissions.

Although the challenges of migrating from paper-based submissions to electronic are numerous, they are also subjective based on a company's current infrastructure and culture. The top challenges faced by a pharmaceutical or biotech company looking to transition to electronic common technical document (eCTD) format for regulatory submissions often include: select a vendor / solution, configure system to support specific needs, train users on system, and roll-out/implement the tools.

Long before a document is approved for use in one or more submissions the source documents themselves have a life of their own as standalone documents. Document templates are created, reviewed and approved, and then used in the creation, review and approval of content documents. An EDM system will help you to manage a variety of information about your documents such as versions, lifecycles states (draft, approved), access/security, and rendering settings (submission ready PDF output with bookmarks, etc).

Submission publishing tools, on the other hand, can assist with managing the use and reuse of those documents in various submissions and help with adhering to regulatory authority standards by having rules in place to assist in challenges such as naming conventions, format requirements, and regional specified eCTD standards (FDA, EU, etc.).

The combination of an EDM system and submission publishing tools provides a robust solution for regulatory affairs submissions. However there are often two essential functionalities that are overlooked and often not found even in the most seamless of integrations between an EDM and submission publishing tools. These functionalities include: submission project management and electronic submission archiving. Below is a description of these functionalities:

Functionality Description
Submission Project Management Management of submission project outline to include documents and tasks due for a submission compilation through the management of activities such as:
  • Submission Outline Template / Project Plan
  • Document Name
  • Assignee (Responsible Author)
  • Due Date (Document/Task)
  • Predecessors (Documents/Task)
  • Auto-Notifications (Status Changes, etc.)
Electronic Submission Archiving Ability to archive the final submission publishing output produced by submission publishing tool combined with the ability to maintain fully functional external hyperlinks (i.e., cross files, from File A to File B).

Submission Project Management

Many companies use Microsoft Project or Microsoft Excel spreadsheets which are updated periodically with information such as: document name, due date, user assigned (author) etc., for documents that will be used in an electronic submission. An EDM system that provides submission project management components will provide a number of features for management of everyday tasks during the submission compilation stage, many of which are automated, such as:

  1. Task notification to authors when a due date is approaching or a predecessor task has been completed
  2. Automatically updated submission project plan as tasks/documents are completed, reducing the time needed during "project update meetings" to get a status of the current submission completion
  3. Reporting capabilities for management to assess risk of delays

Electronic Submission Archiving

Many EDM systems in the market today are incapable of storing complete folder structure with files that contain external hyperlinks that are functional. Many systems are unable to maintain the relative path hyperlink information that is familiar and commonly used in electronic submission such as eCTD submissions and rely on the submission publishing tool to archive the final submission. This means that users who need to view final submission from time to time would need to learn two systems—one that houses sourced documents (the EDM system) and another system to access final electronic submissions (the publishing tool). An EDM system that provides the ability to archive final electronic submissions without losing the functionality of electronic hyperlinks enables an organization to have one central location for all documents pertaining to a product including all source documents, agency correspondence, and final submission, which facilitates user learning and user acceptance.

Patricia Santos-Serrao, RAC, is a life sciences professional with almost two decades of experience in regulatory affairs and clinical areas of the pharmaceutical industry.

Prior to joining MasterControl, Patricia held the position of manager, global regulatory solutions, for QUMAS, a company specializing in quality and compliance management software for life sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the pharmaceutical industry with a particular focus on submission document management for regulatory affairs and trial master files (CTMF) for clinical.

She's worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in regulatory affairs and clinical. She's assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs, and other submission format filings worldwide. A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor of Science degree in Business Administration. Patricia is a member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB). You may contact her at