We realise that the utopian vision of Validation by Design is not always feasible. For example, when a process is transferred between sites, the registered parameters must not be changed and the process as registered has to be validated at the receiving site. Such a situation gives no opportunity for process optimisation, which should be the basis for an effective process validation study.

We can provide process validation plans and protocols which are compliant with current best practices and regulatory expectations.

We can help to trend your validation data and calculate process capability indices for your reports.

By fully understanding your process, you will able tell immediately if something isn't right during routine production.