Agile For Regulatory Submissions Principles

Agile for Regulatory Submissions

Core Principles

Editor’s Note: The core principles governing our Agile for Regulatory Submissions Methodology were adapted from the Principles behind the Agile Manifesto accessed at www.agilemanifesto.org/principles.html

 

  • Prioritize client satisfaction through early and continuous submission delivery
  • Welcome changing content, even late in the project. The agile process considers last-minute update to documents as a rule, not an exception.
  • Deliver functional sections frequently – every few weeks or every few months depending on the size of the submission. A shorter timescale is preferable.
  • Daily collaboration among authors, reviewers, and publishers throughout the project
  • Build submission projects around motivated individuals, giving them the environment and support they need. Trust them to get the job done.
  • Convey information face-to-face. This is the most efficient and effective method of communication to and within a publishing team.
  • Submission-ready documents with internal and external navigation aids are the primary measure of progress
  • Promote a sustainable publishing effort. The authors, publishers, and reviewers should be able to maintain a constant and consistent pace indefinitely
  • Continuous attention to technical excellence and good design enhances agility
  • Simplicity – the art of maximizing the amount of work not done – is essential
  • The best way to determine how to deliver high-quality, submission-ready documents emerges from self-organizing teams
  • At regular intervals, the publishing team reflects on how to become more effective, then fine tunes and adjusts its behavior accordingly