FDA guidance states to complete equipment/computer system validation ahead of starting process validation. Is this an absolute regulatory requirement however?
And if not what if any are the disadvantages of combining equipment/computer system validation and process validation ie. drafting an OQ which checks the functions and operation of the equipment/computer system and also completes tests normally found in a Process OQ such as defining and assessing the capability of the system (process step) over a number of test batches at the process limits?
Finally, is a cumulative sequenced validation of each process step equivalent to a full line process validation?