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April 11, 2017

Can Quality and Agile RTSM Development Peacefully Co-Exist?

Imagine you are in a room with some of the most brilliant system developers in the world. Someone asks for a show of hands, “Who loves quality?” How many hands go up? Any? I’m sure someone out there appreciates quality as much as I do, but chances are it’s not the majority. 

Why is that? We work in a risk-averse, regulated industry. Processes simply have not evolved at the pace of technology. 20 years ago, auditors manually sifted through binders of SOPs, test cases and training summaries. 10 years ago, computer systems validation came into play. Auditors had to shift their focus to technology auditing, which threw everyone for a loop. In this new wave of agile development, the quality process for cloud technology needs to undergo a fundamental shift again. Quality systems and auditors will have different requirements, and that’s ok. 

In such a conservative industry, suddenly storing data in the “cloud” is quite scary, but it is just the evolution of technology. Let’s think about it this way. The “cloud” is simply a large data center. Just like any data center, there are servers, machines, and people that service those systems. Similar to how you would take your car to an expert to get it fixed, you can now leave the maintenance of your systems to the “experts” in the cloud model. It also enables the flexibility to determine where in the world the data is stored (which is important in many EU countries) as well as ensures fool-proof disaster recovery and in the end, provides full traceability and much more robust security and expandability.

So, back to the original question. Can quality and agile development peacefully
co-exist? I believe they can. Not everyone will love quality, but they can understand its criticality. On the flip side, the quality group may not fully embrace or understand “the cloud,” but they can appreciate how technology innovation strengthens the quality process. Below are key takeaways to balance the requirements for quality with utilizing the latest technology innovations designed to accelerate clinical trial delivery.  

  • Align Technology and Quality Processes. Too often, we’ve seen a company focus solely on innovation and then build quality around it. It is incredibly hard to build quality processes after the fact. You can’t simply wrap a cool, innovative system in a quality process from 20 years ago and call it a day.

  • Educate Key Stakeholders. Challenge your developers and quality group to continually evolve together, not operate in siloes. Quality leaders need to understand the latest technology. Developers need to understand regulators’ shift in focus as technology continues to evolve – and embrace a quality mindset.

  • Bring it Back to the Patient. We have a deep responsibility to ensure patient safety and to not compromise data integrity. We are randomizing patients and dispensing drug. When you build your culture on this principle, the conversation around quality changes. 

Whether you are developing systems internally or relying on external systems, the conversation around quality needs to change. The fundamental requirements are still there, but the HOW changes over time. Understanding this differentiation needs to be discussed upfront and built into your culture.

New technology can be scary and candidly we’ve been met with some uncertainty when showing our RTSM system.

If you can do it that fast, do you even have a quality system; is the product validated? Of course! It is just not the quality system you’ve seen from 20 years ago and that’s a good thing. Quality and agile technology really can co-exist.

For more information on agile RTSM development, please click here.

Tag(s): Study Start-Up

Laura Araujo

Laura Araujo has over 30 years of experience in Quality Assurance and Technology, holding various positions in Software Development, Quality Assurance, Software Auditing, and Technology Management. She has had positions in, or related to, the pharmaceutical industry for 25 years. Prior to joining 4G Clinical, for 10...

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