Agile in Highly Regulated Product Development, Part 4
Thus far, this series has looked at three barriers to Agile adoption in highly regulated product development environments: the lack of documentation, the loss of traceability, and the issues with enforceability and auditability. This installment discusses the inflexibility of Scrum tools to integrate with the broader development process.
You want the development team to be as creative as possible, but what they do needs to be directed by the strategic priorities and requirements that are defined by the business. The development team must use tools that allow for traceability and compliance, but the team still needs to be flexible enough to realize the benefit of an Agile process. Dedicated Scrum tools are good for providing flexibility, but not great at meeting traceability and compliance needs.
Scrum and Kanban processes are deliberately designed to be simple. Therefore, it doesn’t take much effort to create an easy-to-use software tool that does only the things you need to do for Scrum and Kanban.
If you’re in a regulated, quality-critical, or functional safety development organization, however, Scrum and Kanban tools can’t come close to meeting your needs. For one thing, those tools don’t offer full support for early requirements gathering. They also don’t support all the process, audit, and electronic signature recording you need to demonstrate control over your process.
Helix ALM (formerly TestTrack) is flexible enough to accommodate your entire process, including Scrum or Kanban delivery, and all your earlier design and approval stages. You can create a fully integrated, end-to-end scalable process that properly records all the approvals and steps necessary to pass an audit. And Helix ALM mitigates the issues other Scrum tools have by being able to fully integrate into the broader process.