Technologies & Procedures
Agile Development. We rely on SCRUM.
With SCRUM we have implemented an industrial standard that is recognized already for many years. A continuous quality review takes place in SCRUM during the complete development process.
During the traditional development process the following problems often occur:
- In the beginning, the client has only a rough idea, which can change and evolve with time
- It is difficult and sometimes even impossible to already plan a complete project from the very beginning of the development
- It is not easy to find a common language between the client and the team of developers, so that the final product fulfills satisfactory the client’s expectations
- It is difficult to implement evolving requirements during the project
Using SCRUM solves these difficulties and makes the client involved during the whole development process
- Better reaction times: The development team can react to evolving requirements or new findings that appear during the development process.
- Transparency: The client can be actively involved during the whole development process and promptly give feedback. A direct communication between the client and the team of developers leads to a better understanding of the client’s needs.
- Cooperation: Release candidates can be sent early to the client, receive feedback and make the client involved in the development process. The experience shows, that testing potential release candidates often leads to new ideas or to a more precise formulation of requirements that were only vaguely described in the beginning. Some aspects that are often overlooked in the theoretical formulation of the requirements can manifest themselves only when the product is tested in practice.
Secure development. We work with modern tools.
High practical orientation. We perform testing in our in-house laboratories.
We can reproduce GC and HPLC use cases on our own instruments in our test laboratories. For Empower we have test installations of all relevant release stands. Therefore, we can guarantee that we can perform independent tests as close to reality as possible.
SCRUM in regulated environment?
In a regulated pharmaceutical environment, the software development is most often done using the V-model. An agile methodology, like SCRUM, seems to contradict the fundamental principles of GMP. Nevertheless, in the last few years there is a discussion whether the agile development cannot be implemented in the pharmaceutical industry, too. This discussion arises from the impression that the stiffness of the V-model does not represent well the reality. Despite the more extensive initial requirements analysis that this model has, changes and additions can still appear in the later product development phase, for example when new information has appeared or the circumstances have changed.
Therefore, the EG-GMP Annex 11 has no standard requirements with respect to the validation methodology. GAMP5 already states, that other models are also possible in addition to the V-model and “Rapid Prototyping” methods are explicitly recognized. However, GAMP5 expects a documentation in accordance to the Good Documentation Practice after every large phase or a milestone. (See also “Scrum in regulated environment”, Prof. Dr. Ayelt Komus und Sabine Komus, 2012, www.chemanager-online.com)
Every development in Scrum is divided in the phases specification, implementation and test.
Each development cycle in Scrum consists of the phases specification, implementation and testing. In this way, the methodology of the so-called waterfall-oriented approach is broken down into smaller cycles.
The involvement of the client, who has the opportunity to quickly inspect and test the product, results practically in continuous acceptance tests. Therefore, this methodology does not fully contradict the fundamentals of the V-model. Nevertheless, for products that will be used in a regulated environment, we cannot implement a pure Scrum methodology, because it must be embedded in a QM-system.
At beyontics we guarantee this by performing a formal validation on any potentially deliverable product. In addition to the extensive electronic documentation, we deliver a documentation in paper form in accordance to the formal standards of regulated environments. The Scrum User Stories present the specifications for the development cycle together with the acceptance criteria and are summarized in practical test cases. A reference is then made in the validation protocol to the initial User Stories.