Agile relies on transparency. Decisions to optimize value and control risk are made based on the perceived state of the artifacts. To the extent that transparency is complete, these decisions have a sound basis. To the extent that the artifacts are incompletely transparent, these decisions can be flawed, value may diminish and risk may increase.
The Submission Tracker is a list of every document that will be submitted to an Agency. The Submission Owner is responsible for the Submission Tracker, including its content, availability, table of contents sections, document production date, title, ordering and status of the document in the publishing process. For simple submissions (e.g. small amendments) the Submission Tracker could simply be a list of documents. Either way the Submission Tracker should have attributes that help estimate the publishing effort
When following the Agile Methodology for Regulatory Submissions, events are used to create regularity and to minimize the need for meetings outside of the methodology. All events are time-boxed, meaning every event has a maximum duration. Once a Sprint begins, its duration is fixed and cannot be shortened or lengthened. The remaining events, such as Daily Stand Up Meetings, may end early if they have achieved their purpose, but cannot run over the allotted time. Such an approach ensures that an appropriate time is spent without introducing wasted effort into the process.
A team using the Agile for Regulatory Submissions methodology consists of a Submission Owner, Publishing Team, and a Submission Coordinator. Agile teams are self-organizing and cross-functional. Self-organizing teams choose how best to accomplish their work, rather than being directed by others outside the team. Cross-functional teams have all competencies needed to accomplish the work without depending on individuals outside of the team structure. The team model integral to Agile for Regulatory Submissions is designed to optimize flexibility, creativity, and productivity.
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.