Regulated industries require all processes and equipment to be validated. The validation process is far reaching, for example this would include: equipment operation, how equipment interfaces with other equipment, how people interface and the procedures they need to follow, with events and alarms defined. And in most cases a human readable report needs to be generated for each batch.
When a change to the equipment is needed, a risk assessment is usually carried out to show how the change would fulfill the requirement, highlighting which processes are affected, and the overall risk exposure to product and business.
With a direct change to equipment the production line is wide open to full validation on all connected systems. Not only the actual change, but all the line processes, procedures, interfaces, communication, archiving and reporting are potentially influenced by the change and need to be tested.
Batch separates the process engineering from the equipment engineering. The equipment is designed to operate within its own limits, the interfaces, archiving, reporting, etc. are designed and validated only once in this maximal configuration. The batch engine designs the process engineering through recipes, which define the process flow and operating parameters. This divide between what is process flow, and what is equipment logic has severe advantages, a change to the process flow or parameter is defined in the batch recipe, the recipe is allowed to use the equipment to maximum functionality, but not further.
With a change to the process flow the equipment logic or connected systems are not changed or affected. The validation exercise is limited therefore to the process change only, the equipment remains untouched ensuring fast, efficient and continued secure operation. Below is a table showing the differences to validation and risk exposure.
With Batch Control new process flows or new products are easy to design. Process change is executed in one location not on several machines. Validation is as efficient as it possibly can be. Production is robust and sustainable. Simple!