In reality, very few companies in any industry use agile procedural models in their pure form. Instead, hybrid software development processes which only pick up on aspects of the Agile Manifesto are developed to counteract the disadvantages of the traditional, cumbersome procedural models. The Scrum method of agile software development was created in 1995. This approach is based on the evidence that many development projects are too complex to be represented in comprehensive plans. However, in its original form Scrum is not applicable directly to the requirements of the industry regulations because the only artifact that cannot be dispensed with is the code.
The goal is to demonstrate that agile development has no negative influence on the quality of the software by implementing quality assurance measures. Through development in short iteration cycles and close cooperation with the customer as well as implementing feedback mechanisms for the team, many agile principles are taken into account and this leads to more flexible and controllable software development.
The art is in defining the procedural model for the development process while taking into account a validation strategy. If the development process and the validation strategy are designed in such a way that the required proof is provided during software development, nothing speaks against the use of agile development approaches. The biggest challenges probably lie in developing a dynamic and efficient process to keep standards, their risk assessments, and the resulting test scenarios upto-date at all times, in documenting them at least to a sufficient level, and in making them available for later change management. Impact analyses are used to determine which design changes affect other software functions or modules. The central element is and remains risk management which ultimately determines the scope of the final test phase.
Such a hybrid model is not an agile method through and through according to the Agile Manifesto; however, according to best practices, it tries to find a balanced middle ground between the classical rich method and the agile method. Always, the ultimate goal is to develop software in such a way that it does not prove to be a threat to data integrity, product safety and quality, or consumer safety. Chemgineering is your partner when it comes to planning and developing agile and GxP-compliant frameworks and the corresponding validation strategies. The times when the V model was the only model for software development in the industry have long since passed.