At a first glance, agile and compliance seem very distant, even conflicting. Traditional compliance processes strive for quality, security and permanent validation of standards through reviews and audits. Inversely, lean development builds optimization from learning in an iterative approach. While the former sees variability as risk, for the latter that uncertainty comes as an opportunity to adapt and generate better outcomes and more valuable assets.
Can these two frameworks ever come to an agreement? In fact, it is possible, since they do share a core objective: they want to build solid systems. Creating an environment that is both agile and compliant is all about narrowing the procedural distance between ideation and verification by ensuring quality through multi-layered testing. This generates an incremental process of building and validating, which is especially vital while dealing with multiple levels of criticality and regulation domains such as FDA ISO 26262.
Thankfully, many directives ask for the exact same standard: procedural transparency. They wish to evaluate how accurately you describe your methodology without skipping any vital steps. Compliance requires efficiency with proper tailoring, so this shouldn’t be a one-size-fits-all matter. In other words, each endeavor should have its own procedures within those defined principles. As such, you work towards developing a solution and its specific verification modes incrementally — the exact same processes as before, just organized in a much more efficient manner.
In essence, compliance is always defined by trust. But complying shouldn’t have to mean inaction. Getting through quality assessments demands constant validation. So, make regulation agile by integrating it with your ideation as you go, providing constant feedback and communication of the methods used.
On this topic you can also watch the video of the expert Peter Pedross from PEDCO. Please follow this link and enjoy!
You can also watch the full show here.
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