Tests and compliance
Most compliance standards, such as ISO26262 for automotive or GAMP for pharma, follow the V-Model as a development process. The V-Model requires the user and system requirements to be decomposed and specifications to be created at different levels of detail. This is the left-hand side of the V. It also requires all the levels to be validated to ensure that the system fulfills the requirements and specifications. This is the right-hand side of the V. Both sides can be seen in Figure 12.8:
Figure 12.8 – Validation in the V-Model
This model must be combined with risk analysis, which is performed at every level of detail. Many documents must be signed during the release phase. This leads to a slow waterfall process with long specification, development, and release phases.
But the standards are based on good practices – and if your practices are better than the ones in the standard, you can justify that in the audits. The standards...
