Change Control Process
The Change Control Process10 A typical approach to change control is outlined as follows: 1. A change is thought to be necessary (eg, a line operator thinks that changing a manual…
Role of Change Control
The Role of Change Control The change control program is the mainstay of maintaining a compliant state of the process or operation. It is used in every aspect of the…
Process Validation (PV)
Figure 1.1 Original approach=VALIDATION. Figure 1.2 Current approach=COMPLIANCE. It must be understood that maintaining compliance is a never-ending process. PV is not one step, thus it really isn’t the “last…
