These are exciting times to serve the life sciences sector - thanks to technological advances, innovations abound and progress marches on at a lightning-fast clip. Working with a wide variety of organizations, @Rina Nir (AC) from Radbee sees two very different types of teams searching for an answer to the same fundamental question: "How do I best do Agile and still comply with regulations?" (For example, ISO-13485, GAMP® 5, etc.)
On one side there are traditional pharmaceutical companies. These companies have established ways to create software and have the manpower, capacity, knowledge, and procedures to manage compliant software systems. Still, there are significant inefficiencies related to time, effort and budget in doing business as usual. Given the copious benefits of both Agile and DevOps, as well as the ever-growing recognition of their efficacy, many pharmaceutical companies have realized they can no longer continue doing things the old way. For them, the key question is: "How do we continue to be compliant, but also adopt Agile methodologies?"
On the other side, there is a flood of young, highly successful companies who have been developing great software in Agile methods outside the scope of regulated software. (Rina is looking at you, ahem, health and fitness apps that shall remain nameless). These companies are extending their reach and moving into new territories which now includes operating in regulated spaces. These teams may have mastered Agile, but for them, the question is: "How can we continue to be Agile, but also be compliant?"
As with any organizational change, making it happen depends on the perfect blend of process, tools, and culture. Here's Rina's take on how to make this equation work!
There is no way around it: GCP, FDA Quality System Regulation, and ISO-13485 each impact how you do Agile. It's worth acknowledging this fact and making the most of it. These are my top three observations about how Agile in life sciences is different:
Tools can be hugely helpful in reducing the burden of compliance, particularly in the following areas:
Structure for Jira visualizes traceability matrices so that it's easy to keep your traceability during the development.
No matter if you are changing from waterfall to Agile, or from non-regulated to regulated, a culture change is required. As it goes, this is the aspect that typically is hardest and slowest. My two cents on this kind of shift:
Contrary to popular opinion, being both Agile and compliant is not only possible, it's preferable. Rather than look at it as if one side slows down the other when you see both processes as complementary, you get a clearer picture of what you were striving for in the first place: organization-wide victory.
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