Agile According to GAMP5 2nd edition: A Quick Overview and Pharma Applications

Agile According to GAMP5 2nd edition: A Quick Overview and Pharma Applications


  • As opposed to waterfall’s linear development methodology of defining/collecting requirements before moving to design/development, Agile’s development methodology principles focus on discovery and iterations (ongoing change), using The Agile Manifesto 
  • The Agile Manifesto came to exist in early 2001 as the following: 
  • People and their interaction over processes and tools 
  • Working software over all-encompassing documentation 
  • Customer collaboration over contract negotiations 
  • Responding to change over following a plan 

That is, while there is value in the items on the right, we value the items on the left more.


  • Agile can be applied to diverse computerized systems, especially beneficial for less defined scope/requirements/high risk implementations. GAMP 5 (Good Automated Manufacturing Practice) acknowledges the coexistence of Agile and linear approaches in the interaction of supplier and regulated company life cycles. 
  • The basics to Agile could be found following adopting a proper framework suitable for the scale, complexity, and dependencies of the project/system. Scrum is the most popular framework of Agile. 
  • The culture, values, and priorities of an organization form the employees’ mindsets. Therefore, for an efficient adapting of Agile methodology, there needs to be a mindset shift from “fixed standards, workflows, and expectations” towards a “discovery-responsive, continual improvement, and collaborative mindset”. 
  • In its essence, Agile achieves a highly controlled change management by implementing robust controls and promoting team accountability along with exerting necessary additional control/oversight. By adhering to a well-established Agile methodology, not only on-time delivery is ensured, but also quality is guaranteed. 

Although the pharmaceutical industry is traditionally characterized as a strictly regulated environment, we are witnessing a shift towards Agile methodologies despite seeming incompatibility with well-established waterfall methods of processes.  

We observe that Agile way of working within pharma is mainly used for: 

  • Research and Development (R&D) (creating GAMP category 5 software), 
  • Vendors creating SAAS (Software as a service) products (software) that support GxP processes, 
  • IT. 

This shift has been enabled by adopting Agile ceremonies and practices such as: 

  • Introducing daily progress and refinement discussions within teams (as in Scrum), 
  • Empowering teams to make decisions, 
  • Creating cross-functional team structures, 
  • Active collaboration with customers and/or clinical staff, 
  • Iterative way of working (small enhancements using sprints), 
  • Presenting the product to the stakeholders regularly to get approval and/or feedback. 

Through mapping the Agile deliverables to the expectations of regulatory bodies/customers and, therefore, promoting organizational agility through the above-mentioned techniques, a company could expect: 

  • Increased intra-company collaboration and improved communication, 
  • Efficient planning sessions leading to accelerated and in-time obstacle resolving, 
  • Expedited brand strategy implementation, 
  • Lower development costs, 
  • Increased speed to market, 
  • Etc. 

Although numerous validation processes in the pharmaceutical industry still adhere to the traditional waterfall method, transitioning towards a hybrid approach that combines elements of both waterfall and agile methodologies could yield significant benefits. Equivalencies exist between these two methodologies; for instance, initiatives, features, and epics can parallel User Requirement Specifications (URS), while user stories may correspond to Functional Specifications (FS). Ultimately, both methodologies aim to ensure the successful achievement, testing, and verification of a system or product's intended use.  

So, the question is: where do you envision Agile fitting into your business strategy?  

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