As engineers and project managers, we like certainty. Detailed clear requirements, defined up-front, against which we can design, cost and plan. However the modern world is a dynamic, fast-changing place. Technological advances and changing customer needs mean that we sometimes need to adapt and innovate throughout the lifetime of a project. But can we combine GAMP5 and agile development?

The traditional waterfall model of project delivery, although still very valid in many cases, must be challenged as we find innovative new ways of delivering quality and success in a fast-changing environment. As we focus on the needs of the customer rather than what is easiest for the project delivery team, this might mean that success criteria are based on value and quality rather than cost, time and scope. Delivery and product acceptance might need to be incremental rather than all-at-once.

Changing Mindsets

ISPE – International Society for Pharmaceutical Engineering – has been considering the implications of rapid development on the GAMP5 model, and providing guidance on how we can adapt to this new way of thinking and doing. They talk about changes in Mindset, Mechanics and Measures that are needed to support Agile. This describes a general concept rather than a defined methodology. With empowered teams and robust procedures and tools, product quality need not be compromised and we can still retain full traceability and approval, important in regulated industries.

Mindset encompasses company culture, values and priorities. It is the starting point for working in an agile way. ISPE talk about Discovery vs. Certainty. Instead of saying ‘we can’t do that, our process doesn’t allow that, we should ask ourselves ‘How can we manage this in a way that still meets the customer and regulator’s needs and follows the principles of GAMP®5?’. Creativity and lateral thinking become part of the engineer’s work as much as following the spec.

To be agile in our project delivery, we need:

• A Discovery Mindset, rather than Certainty Mindset
• A culture of innovation and continuous improvement
• Empowered teams
• A consistent and repeatable way of agile delivery
• Communication and alignment across all the stakeholders

Mindsets and Regulated Industries

It might appear that Discovery Mindset can’t work in highly regulated industries such as Pharmaceuticals. We are accustomed to processes and procedures that, we think, constrain us into a Certainty Mindset. That is, gather all requirements and get them signed-off; design and sign-off; build the system, test and accept it. And along the way, producing a mass of evidence to show what our plan was, how we executed it, and finally what (if any) deviations occurred.

But, with a change in mindset, it is possible to achieve the same levels of GxP compliance, governance and evidence even when following an agile model. Plus be auditable. This is because processes are the mechanics of what we do, and are not changed by the mindset in which we do it. If we apply – and adapt – the same processes of GAMP5, we will still achieve the quality and robustness we need. 

By acknowledging that complexity makes it hard to accurately predict the future and change is certain, the discovery mindset enables us to manage learning and adaptation throughout the development lifecycle in a controlled way. Embracing change, in a controlled manner, throughout the development lifecycle aligns with Quality Management principles, regulatory requirements and helps to increase the safety of systems, products and therefore patients.

Mark Whelan – Lead Quality Specialist
– Technology Assurance and Change Programmes NHS Blood and Transplant

If there is one thing that the COVID-19 pandemic taught us, it is that the ability to move fast and adapt to circumstances is sometimes more important than having a fully-formed plan before we start.

As a supplier of bespoke highly-validated automation solutions, at Feed4ward we have always had a forward-thinking attitude towards managing change. Plus we have invested in systems, tools and processes that help us deal with uncertainty and change.

Why not challenge us with your next project? Whatever your business needs are, contact us to discuss how we can help deliver the automation you need.

[WIth acknowledgement and thanks to Andrew Mcdonagh, Staci Dubovik, Mark R. Cherry, Donal O’Brien and Stephen Jones of ISPE]