Documenting Software for FDA Submissions

The Agile methodology is an important tool for software project management.


The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing. Healthcare is one of the many areas in which the Agile methodology is very well suitable and adaptable.

The Agile methodology can be used to help software project managers forestall and address major bottlenecks of software project management, such as vulnerability and mercuriality. It helps to prevent project delays and thus cuts costs. An important feature of Agile is its flexible nature, which gives it the ability to accommodate and ingest many new changes that take place as the project develops.

In reviewing project progress at every stage by validating roles, steps and processes functions; Agile prevents piling of work at later stages of the project. Protect managers have reiterated time and again the ability Agile has in the background of severe constraints of time and money.

Agile has its drawbacks

Agile has its drawbacks

However, this is not to suggest that all is well with Agile, and that it works in every setting and in every situation. For Agile to work efficiently and to deliver the results it sets out to; the most essential precondition is thorough and complete, tightly knit team coordination. It requires very active and strong participation from the team leaders, subject matter experts and stakeholders.

The suitability that Agile has for the healthcare industry is well-established. But, being a highly teamwork-dependent initiative; Agile also has the potential to fail in situations in which all the factors that make it work fail to gel or synchronize. Unless those in the healthcare industry who want to use Agile methodology as a means for saving money, time and other resources are confident that they can bring together all that is needed for making Agile methodology useful and effective; it is not going to be of much use.

A learning session on the applicability of Agile methodology to healthcare

So, how does the healthcare industry adapt Agile methodology for its use? How does it overcome the deficiencies and shortfalls of this methodology to optimize its use and leverage it for better results?

An in-depth exploration how Agile methodology can help in documenting software for FDA submissions will be the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

Brian Shoemaker, who consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures, and has worked with companies in Germany and Switzerland as well as the U.S., will be the Director of this seminar. Please visit Documenting Software for FDA Submissions to enroll for this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarification of doubts about the suitability of Agile to IEC 62304

At this seminar, Brian will clarify the criticism in healthcare software industry circles that Agile, because of its lack of documentation runs counter to the lifecycle standards mandated in IEC 62304. He will explain how clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution, which go into the IEC 62304 principles actually strengthen, rather than weaken or controvert the Agile methodology. In fact, as the AAMI Agile report (TIR 45) has stated, the proper application of Agile, with its emphasis on nimbleness and ongoing learning, into a quality system and safety risk management can meld with and facilitate in fulfilling regulatory expectations of well-documented development.

In fact, documentation in Agile actually helps in taking advantage of iterative development. This is because since the IEC 62304 does not specify any lifecycle model; documentation can grow out of the required iterative activities. By developing incrementally and helping prevent last minute anxieties and worries; Agile is highly useful in many disciplines of healthcare. Its use for hazard analysis is extremely well suited. This makes risk management more robust by being included in iteration tasks.

In all, this will be a highly educative session at which all the aspects relating to the applicability of the Agile methodology to software documentation for FDA submissions will be explained. Brian will cover the following areas at this seminar:

  • Agile vs IEC 62304: an apparent contradiction?
  • The role and value of documentation
  • The REAL regulatory requirements
  • Specific documents required for an FDA submission
  • Areas where most development processes bog down
  • Iteration – well suited for risk, usability, and design reviews
  • Key practices to bridge the Agile and regulated worlds
  • Agile is not only acceptable for medical device software, but can be clearly superior.