It is clear that the objective of the validations is to look for the quality of the systems, although the reality, most of the time, looks only for compliance. And it’s not the same. The second assumption emphasizes that there is a validation documentation that allows the inspections to “pass”, instead of complying with the GMP criteria. The consequence is that, increasingly, there is greater awareness of the risk of non-compliance than of the risk of non-quality. If to this is added an over interpretation of the regulations and recommendations, exaggerated and misguided validation activities are achieved.
At ASYVAL we work so that our validations serve to improve the quality of the systems without carrying out activities that do not add value. To do this, we focus the tests on high-risk areas, with the strictly necessary resources, so that validation times and costs are not lengthened. We carry out an efficient validation life cycle for each particular system, without using validation templates and reducing release times.