Introduction
A common issue during the development of an IT system is the misalignment between user needs and the functionalities implemented by developers. Users often prioritize different aspects than developers, who tend to focus on technical feasibility and optimal code structure. As a result, the functionalities expected by users often differ from those delivered by developers, leading to long-term dissatisfaction and additional development costs.
Another significant challenge is documentation. Creating documentation that is clear for both users and developers is extremely time-consuming and requires expertise in both areas. New features are often added as separate modules, which can lead to a loss of system coherence over time. Maintaining integrity—ensuring that every new development and feature aligns with the original system structure—is an important goal, but achieving it is not straightforward. Similarly, auditability often appears as a separate function within the system, adding complexity and maintenance requirements. This also reduces the system's transparency and efficiency, as audit-related information may require separate documentation and data structures.
Solution
These challenges in system development were effectively addressed using the Action-Parameter (AP) methodology, which provides a comprehensive approach that aligns both user and developer perspectives, ensuring system unity and auditability. Under the AP methodology, every action is associated with defined parameters, which are documented in a clear and structured manner. This unified approach ensures that user needs and developer implementations move in the same direction, maintaining system coherence throughout all development phases.
Key Steps of the AP Methodology:
- Defining Actions and Associated Parameters in Documentation: The first step is the clear documentation of all actions and their associated parameters. Each action is linked to specific parameters that describe the functionalities in detail. This ensures that both users and developers see and interpret the same system, avoiding misunderstandings.
- Maintaining System Structure: Another critical aspect of the AP methodology is preserving the system's structure. This approach unifies the system from the database structure to the code and documentation, making the current operations more transparent and ensuring long-term sustainability.
- Integrating Auditability into the System: According to the AP methodology, auditability is built into the system as a core feature, not as a separate module. This allows every activity to be automatically auditable without the need for additional functions. As a result, every system function and development becomes auditable, meeting strict GMP and other regulatory requirements.
Results
The AP methodology, introduced in May 2024, was tested through the parallel development of two GMP-compliant systems, and the results confirmed its effectiveness.
- Transparent Structure for Both Users and Developers: The AP methodology ensures that users and developers see and understand the same system, reducing errors and minimizing time investment. The unified structure enables faster and more efficient development, as both sides clearly see the system's logic and operation.
- Faster and Safer Feature Development: The AP methodology significantly accelerated the development of new features. Compared to the previous system, implementing a new feature is now much faster, and the unified documentation and structure have significantly reduced development risks. During coding, developers can clearly see which parameters to rely on, resulting in greater security and fewer errors.
- Fulfilled Auditability Requirements: With the introduction of the AP methodology, auditability is automatically implemented for every new feature or system update. This not only ensures compliance with regulations but also makes the auditing process faster and simpler, as all information is available in a predefined format.
- Matrix of System Functions and Parameters: Another advantage is the creation of a matrix that includes all system functions and their parameters. This matrix concisely and clearly summarizes the system's operation, making it easier for new colleagues to onboard and providing a significant advantage during audits. The matrix ensures that the system's transparency is clear to all stakeholders, reducing interpretation issues and enhancing documentation.
Conclusion
The application of the AP methodology has bridged the communication gap between users and developers, and the shared documentation has made it easier for users to understand the system's operation. The unified documentation allows users to better understand the system's data structure and formulate new requirements based on it. This business advantage is particularly important in a rapidly changing market environment, where adaptability and efficiency are key competitive factors.
The structured framework not only speeds up development but also makes it more cost-effective, as developers work on a system where every new feature is built on a common logical foundation. Meeting user needs has become simpler, increasing customer satisfaction and simplifying long-term system maintenance.
Recommendation
Based on our experience, we recommend conducting a feasibility study for any organization considering a system structure transformation. Transforming existing systems requires significant time and resources and can often be more costly than implementing a new framework. The feasibility study should examine the costs of maintaining the current framework and explore potential transformation strategies to enable rational decision-making. The introduction of the new AP methodology is particularly recommended for organizations where auditability and system transparency are critical, as these aspects provide significant business advantages.
