Computer system validation is more than a compliance requirement. It’s a way to improve efficiency and enhance quality. Regulated companies must ensure that their digital tools are fit for their purpose. Incorrect or untested systems could harm patients, drug manufacturers, and the wider business community.
Requirements Analysis of Computer System Validation
Computer system validation is a process with many steps. The first step is identifying and understanding user requirements. This step helps the team know if the conditions meet the company’s needs. It is the basis for the scope and strategy of the validation project. This step also helps the team identify non-critical and critical requirements that must be fulfilled for the system to function. These requirements can be categorized as required, desirable, or optional. The required requirements are essential to product quality, patient safety, or regulatory compliance. Desirable requirements are those that would improve the functionality of the system or increase its aesthetic. Optional provisions are those that could be removed or transferred.
The requirement analysis phase also includes creating requirement models that help the team understand the system. These models may consist of data flow diagrams, entity-relationship models, or state-transition diagrams. These models allow the team to see the system in graphical forms that aid them in discovering flaws, inconsistencies, or missing elements. They also help to find any designed constraints that the system may have.
The system design phase of the computer system validation process involves designing the physical layout of a computer system. It includes the user interface design, the hardware architecture, and determining how data will be stored. It is also where the scope of the project is defined. It includes identifying what parts of the system should be validated and which should not. The GAMP guidelines suggest that the complexity and, therefore, risks inherent in each category, of either software or hardware, be determined to establish an appropriate computer system validation strategy.
The coding and configuration requirements must be clearly defined to conduct a risk assessment and correctly describe the verification tests. The system design phase should include a high-level project plan, resource estimates, benefits and restrictions, and a cost estimate.
It is recommended that a documented change control system be implemented to manage the computer system validation project. It will allow for the tracking of changes to ensure that the correct documentation is created and the appropriate testing is conducted. It will also ensure that the proper procedure is followed for archiving the data to make it available for future use and enable the generation of an audit trail.
Once you’ve figured out what needs to be validated, you’re ready for the configuration phase. It is where all your hard work comes together to create a system that can be tested and formally documented for compliance. It is time to begin identifying systems and environments and assembling manual checklists for them. Once all designs have been cataloged, the data should be compiled into a single source of truth for your application. All parties participating in your process should be able to access the repository where this data is stored, and any sensitive data should be encrypted before being kept there.
This repository should contain all of the information you need to know about your computer system’s current state, including a detailed breakdown of all components and their relationships to each other. The information should be in a format that’s easy to read and edit, like XML files or plain text. Using a system-level bill of materials will help you identify dependencies and spot potential issues quickly. Some software uses binary file formats that require a specific application to interpret them, and these can be more difficult to maintain without additional tools.
Computer system validation is a detailed process to ensure that the computerized system does what it was designed for in a consistent and reproducible manner (suitable to use), ensuring data quality, security, and compliance with GxP regulations. It is achieved through the systematic approach to evaluating, testing, and documenting the processes that the computerized system will be used. The first step in the computer system validation process is to characterize the system, which determines its functionality and delimitation. It also establishes the scope and appropriate strategies for computer system validation.
The design phase should include:
- A complete system description.
- Vendors and costs.
- High-level project plan.
- Resources and timelines.
It is essential to gather this information before starting the risk assessment. Any risks identified in the risk assessment may influence the final decision on what controls are needed for the system during its operational qualification. Risks that cannot be eliminated in the design should be reduced to an acceptable level using a risk reduction matrix and controls. The test plan is then developed, including the detailed tests and procedures required to verify that the system functions as intended.
Once the computer system operates in production, it must be updated, improved, and formally documented. It is a cyclical process that continues throughout the life of the system. You must have a good document management strategy to ensure qualified personnel documents and carry out all system changes. Any system changes you make that might harm patient safety, product quality, or data integrity must be subject to a risk assessment. It would help if you weighed these risks according to their importance and the effect that they would have on your customers.
Regulatory bodies expect you to carry out this analysis and take steps to mitigate the risks. You will also need to develop a data archiving strategy for the system that moves data out of active use in your environment into a separate storage area where it can be retained for long-term retention. It must be completed in the retirement phase of the validation cycle.
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