Validation is the analysis of whether something is appropriate, relevant and meets the criteria for its use or application in a given situation. It confirms whether its use leads to meeting assumed objectives, in other words whether it is effective.
How to define information systems (IS) validation then?
Validation of an IT system used in a company will constitute confirmation of the suitability and adaptation of that system to:
The IT system validation process concerns its whole life cycle, i.e., it starts at the moment of its conception and design, through its operation, and ends when it is withdrawn from use in an organisation. What is also important, is that the risks associated with the quality of the system are analysed during its entire life cycle.
The phases of an IT system validation project depend on at what point in its lifecycle the project commences. It will also be important whether the system has been developed in-house, purchased directly from the manufacturer, came from its partner channel or is a so-called Commercial-off-the-shelf (COTS) solution. It is significant due to the fact that the validation analysis will cover the system supplier's activities related to:
The IT system validation project, on the other hand, will consist of the following stages:
The benefits of system validation will be closely related to the objective set at the start of a project.
If the project covered the validation of an IT system, e.g., in a pharmaceutical company, the project completion and implementation of recommendations from the validation report will provide a high degree of assurance of compliance of the system with Good Manufacturing Practices required by the regulation to the Act, and the process, method or computer system will lead in a repeatable way to results which meet specific acceptance criteria. This is a prerequisite for allowing the system to be used in a pharmaceutical company.
If the project concerned validation of the way and quality of implementation, or was conducted in a company already using a computer system for many years, it will obtain recommendations related to decisions to be taken in order to improve quality and adapt the system to the applicable legislation and business needs and requirements. In this case, recommendations may relate to:
The range of possible computer system validation works:
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