The ‘how to’ guide to implementing Agile in GxP
The publication of the Guidance on the use of Agile in a GxP Environment document in 2017 was well received.
It described how the use of Agile in a GxP environment was limited due to perceived regulatory risks. The Guidance provides an approach that ensures delivery of software solutions while at the same time maintaining regulatory compliance. It also details the approach and key prerequisites needed for Agile to be successful.
Agile improves IT development by carrying out design changes with the customer—going through repeated iterations. This ensures that what is eventually delivered is actually what the customer needs, and with reduced errors after implementation.
However, while the benefits of Agile are clear to see where it is being used, there remains a limited uptake of the approach in the GxP context due to some stakeholder concerns. And although a lot of information about Agile is publicly available, this is much more limited for GxP areas of the biopharmaceutical industry, which has often led to a lack of understanding among key partners.
What are the challenges?
To provide more practical advice on how to implement Agile in GxP, the BioPhorum IT Agile workstream has worked hard to understand these concerns and how to make a business case to decision makers.
It found that the main challenges facing companies looking to adopt Agile are:
- Perceived compliance risks
- That benefits have not been clearly explained
- There is no clear path to easily move to an Agile approach.
The impact of these issues include:
- That the benefits of an Agile approach are not being delivered
- IT systems may be developed inefficiently
- IT teams often struggle to support increasing and constant business, process and organizational change
- Compliance requirements may be seen as blockers, not
To overcome these challenges, the team of subject matter experts has published a supplementary guide—the Agile in GxP Companion—to be used alongside its original guidance.
What does the Companion deliver?
The Companion is less about ‘what is Agile’ but more ‘how to do it’ in the biopharma arena. It also emphasizes the importance of a clear roadmap. “When you are thinking about making a change, a couple of things you have to understand are ‘where am I now?’ and ‘where do I want to be?’” explained BioPhorum Facilitator Jonathan Dakin. “So, the Companion illustrates the journey to a fuller implementation that is appropriate for the organization.”
The Companion roadmap details five levels to full Agile working that will help companies determine what level they are currently at and what they need to do to progress to the next stage. This approach will help companies understand how to implement Agile in GxP environments more rapidly and effectively.
The Companion will help deliver the following benefits:
- Remove the barriers to Agile adoption
- Provide clarity on the benefits of Agile
- Clearly explain how to move to an Agile approach and how it forms part of an organization’s digital journey
- Deliver better quality products that meet customer needs earlier than traditional development routes.
When delivering the Companion, the Agile workstream was successful because of the proactive and trusting collaboration with companies, using real-life examples in the document and by differentiating Agile in GxP for biopharma.
Lori Otto from Information Quality Services at Eli Lilly, who co-authored the Companion, believed that it was a vital step to Agile adoption. She said, “I hope the Companion will provide you with valuable information to help your company develop a roadmap to move forward in your Agile endeavors.”
The BioPhorum effect
Most of the workstream members who produced the initial Guidance remained on the team to develop the Companion and ensure a consistent approach. Some new companies—at different stages on the path to Agile implementation—also joined the team to bring new perspectives to discussions.
Otto explained that it was an “excellent experience being part of the BioPhorum team and meeting other pharma companies who are on a similar journey with adopting Agile in a GxP environment.”
Matthew McMenamin, Manager, Systems & Tech at GSK, added, “Working with the team on the generation of this guide was an outstanding experience. Not only does it provide an excellent roadmap through the Agile for GxP realm, I also learned a great deal through benchmarking with my peers and avoiding pitfalls through their lessons.”
Publication of the Companion marks the formal end of the workstream. However, the network will stay connected through a BioPhorum IT Compliance Community of Practice. This will look at how Agile is being implemented and will continue sharing information and best practice on Agile and other IT compliance topics.