The Agile Methodology and Regulatory Publishing

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The following post is the second of six in GlobalSubmit’s Agile for Regulatory Submissions series. GlobalSubmit’s regulatory services team employs the Agile Methodology for submission projects. By instituting Agile principles, our team has been very successful in delivering high-quality submissions ahead of schedule while maintaining constant, clear lines of communication with sponsors. To date, 75% of the regulatory submission projects executed by GlobalSubmit have been completed ahead of schedule.

 The content used in our Agile for Regulatory Submissions series is adapted from the original work of Ken Schwaber and Jeff Sutherland called the Scrum Guide under the Attribution Share-Alike license of Creative Commons. Our series, which differs from the original work in the industry it describes, end product of the Agile process and professionals involved in producing the end product, is available for license under the identical terms.

What is Agile for Regulatory Submissions?
Agile in the context of regulatory publishing is a framework within which professionals can address complex, adaptive problems, while productively and creatively delivering regulatory submissions with less effort and higher quality.

Agile for Regulatory Submissions is lightweight, simple to understand, and difficult to master.

Agile is a process framework that has been used to manage complex product development since the early 1990s. Working within the Agile framework, you can employ various processes and techniques. For the purposes of this article and our entire series of articles, the relative efficacy of regulatory publishing practices guided by the Agile methodology are made clear so that you can understand the process and its advantages.

The Agile framework consists of teams and their associated roles, events, artifacts, and rules. Each component within the framework serves a specific purpose and is essential to Agile’s success and usage.

The rules of Agile bind together the events, roles, and artifacts, governing the relationships and interaction between them.

The Theory Behind Agile for Regulatory Submissions
Agile is founded on empirical process control theory, or empiricism. Empiricism asserts that knowledge comes from experience and making decisions based on what is known. Agile employs an iterative, incremental approach to optimize predictability and control risk.

Three pillars uphold every implementation of empirical process control: transparency, inspection, and adaptation.

Significant aspects of the Agile for Regulatory Submissions process must be visible to those responsible for the outcome. Transparency requires those aspects be harmonized so observers share a common understanding of what is being seen, for example:

  • A common language referring to the submission process must be shared by all participants
  • The professionals performing the work (regulatory publishers) and those accepting the work (reviewers, QC’ers) must share a common definition of “done”

Agile users must frequently inspect artifacts (i.e., Submission Tracker, Issues Log, etc.) and progress toward a Sprint Goal to detect undesirable variances. Inspection should not be so frequent that it interferes with the work. Inspections are most beneficial when diligently performed by skilled inspectors at the point of work.

Agile prescribes four formal events for inspection and adaptation.

  • Agile Sprint Planning
  • Daily Stand Up Meeting
  • Agile Sprint Review
  • Project Retrospective

These events will be explained throughout our Agile for Regulatory Submissions series.

©2015 GlobalSubmit. Offered for license under the Attribution Share-Alike license of Creative Commons, accessible at and also described in summary form at By utilizing this Agile for Regulatory Submissions content, you acknowledge and agree that you have read and agree to be bound by the terms of the Attribution Share-Alike license of Creative Commons.

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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