GxP-Blog

In times of increasingly complex software solutions and IT architectures, the need to have a detailed list of requirements at the beginning of a project can present a major challenge. To develop complex, superior quality solutions faster and more efficiently, agile software development has become increasingly important in recent years. The GAMP 5© guideline, published in 2008, still is considered the gold standard in principles and procedures for the validation of computerized systems in the pharmaceutical industry. For the first time, the wide range of procedural models, methods and patterns of development were approved explicitly, including agile software development methods in addition to the V-model of software development. Accordingly, the V model no longer is “the standard” for validation procedures.

The Manifesto for Agile Software Development (“Agile Manifesto”) written in 2001 is the smallest common denominator of all agile procedural models and represents a movement counter to traditional models. The goal of the Agile Manifesto is to find ways to bring software developers closer to their core competency, namely, the actual development of software. Over the years, software development was difficult to realize because the rigid phase model was complex and involved moving targets. In fact, the key lies in working in iterations, as Barry W. Boehm once described in his spiral model. Agile has taken up this aspect of software development through its vast number of iterative and incremental methods wherein it describes the steps to be taken to realize a software project. In contrast to the spiral model, the iterations are considerably shorter and at the end of each is software that is not just a prototype and that runs with high quality code. Agile software development has proven itself in countless projects, and it can be expected to continue to play a major role in software development going forward.

Many of the regulated companies in the industry shy away from using agile procedural models. This is due, among other things, to the fact that one of the guiding principles of the Agile Manifesto states that the software always takes precedence over comprehensive documentation. It is precisely this comprehensive documentation, however, which is an essential component of the proof of the software’s validity in the industry. If software is viewed as a life-cycle model from its development to its implementation and use and then on down to its discontinuation, the importance of developing secure software and the relevant documentation as part of the life cycle becomes apparent. During development, the requirements are specified and the risks are identified. Afterwards, the program code is written and tested to ensure it meets the requirements and doesn’t pose risks. Inspectors who wish to check the validity of a computer-assisted system usually find it difficult to gain insight into a supplier’s development process. During inspections performed by representatives of official agencies, the validity of computer-assisted systems is examined using their life-cycle documentation. This is achieved using classical design documentation, risk assessments, and validation plans and reports as well as other concepts consisting of test plans, test logs, and test reports.

The inspector concentrates mainly on the validation activities that were carried out during implementation; however, the software development process plays an essential role in the life cycle of a computer-aided system. To develop software that meets the requirements of the regulations that apply to the industry, the above-mentioned life-cycle documents must be provided as proof of quality.

The Agile Manifesto does not provide for the retention of the above-mentioned evidence, in fact, it even contradicts the requirement for keeping documentation.

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.