The biopharmaceutical industry is challenged to continually deliver and maintain products in a cost-effective way while retaining regulatory compliance. An Agile approach to software development supports the need for an effective and efficient business. However, use of Agile in a GxP environment has been limited due to the perceived regulatory risk. This guidance document provides an approach that ensures delivery of software solutions while at the same time maintaining regulatory compliance.
While this guidance documents details the approach proposed it is clear that key prerequisites need to be in place for Agile to be successfully adopted, including senior management support and engagement, the use of computerized systems and tools in the management and control of the required deliverables (including electronic records with electronic signatures and audit trails), and the full support and engagement of the quality team. The approach detailed below retains the key traditional stages of the validation plan and validation report, while adapting the design, build and test stages to provide an Agile approach. The guidance document is based on the delivery of enough functionality for the system to be usable (implementation phase), with further functionality being delivered via change requests (operations phase). Further details of how this would work in reality are provided.
Using the guidance can enable companies to implement software systems in a GxP environment while delivering to the business the benefits of cost, speed and quality, and at the same time retaining full regulatory compliance.