The problem with the qualification process
Software qualification is the process of validating and verifying that a software system meets the requirements and specifications set out for it, ensuring it performs as expected under certain conditions. It is a part of software testing that focuses on evaluating the capabilities and characteristics of a program to ensure it meets its intended use.
The influence of laws and legal aspects on software qualification is significant, especially in industries that are heavily regulated. Legal requirements can dictate the standards and procedures that must be followed during the software development and qualification processes. Certain sectors, such as healthcare, finance, and aviation, have strict regulatory requirements for software. Non-compliance can lead to legal penalties, including fines and sanctions. Legal frameworks define the liability of software manufacturers and developers in cases where software failure leads to financial loss, injury, or death. Ensuring that software is fully qualified reduces this legal risk.
The qualification process for software is very complex and labor-intensive. Requirements can evolve during the development process, requiring ongoing adjustments to the testing and qualification plans. Additionally, software needs to be tested in various environments to ensure it works under different conditions, which can be resource-intensive.