Today, agile methods are used as standard in the development of software. However, software that is primarily developed for GxP-relevant use must also meet the applicable compliance requirements. This is because well-documented software development significantly reduces the effort involved in the subsequent validation of the computerized system in the pharmaceutical environment. On the surface, the principles of agile software development appear to be in conflict with the applicable GxP requirements.

However, as described in detail in GAMP 5 Second Edition, agile approaches and methods can be documented appropriately without reducing the benefits of the agile approach. This requires adherence to standards when creating requirements, for example as epics or user stories, the integration of risk assessments and documentation tasks in the agile workflows and the software development tools used (software development tool chain). In summary, agile software development models and GxP requirements may seem contradictory at first glance, but careful integration of both approaches can help to reap the benefits of agility while ensuring the necessary GxP compliance. However, this requires specialized knowledge and a thoughtful adaptation of agile methods to the strict regulatory requirements.


  • Planning including specifications, implementation and realization of an agile software development model
  • Definition of roles and responsibilities
  • Definition of standards for the collection and management of requirements (including regulatory and security requirements)
  • Integration of risk management
  • Definition and implementation of an agile test strategy and test planning (automated / manual)
  • Definition and management of documentation requirements taking into account the software development tool chain
  • Compliance marketing strategy
  • Implementation of mock audits (preparation for audits and inspections)
  • Audit, training and support
  • Specialized GxP training for software vendors


  • Agile software development models are methods and practices for software development that are characterized by incremental, iterative processes. These models emphasize flexibility, collaboration, continuous improvement and the rapid delivery of working software products. The best-known agile methods include Scrum, Kanban and Extreme Programming (XP).
  • Agile methods emphasize flexibility and adaptability, which often leads to less formal and comprehensive documentation. GxP requirements, on the other hand, demand detailed and formal documentation of all development and validation steps.
  • Furthermore, Agile models develop software in small, usable increments, which means that full functionality is only achieved over the course of several iterations. However, GxP often requires comprehensive validation and verification of the entire system before deployment.

Q-FINITY’s innovative approaches in the field of agile software development for GxP software are characterized, among other things, by quality tailored to the customer’s requirements and tailor-made solutions for all demands. Our methods and procedures are based on the experience we have gained with over 150 customers. We involve our customers closely from the outset and thus ensure that pre-defined goals are achieved.