What is ISA S88: 

 

The S88 standard was approved by ISA (The International Society of Automation) in 1995 and provides models and terminology that an engineer can use to specify automation requirements in a modular fashion.

S88 is well known and largely followed standard in process-automation providing consistent set of standards to write an approved functional specification for computer system validation, especially in regulated industries such as pharmaceutical Industry.

Basically It is related to the batch process control issues and was later tackle the manufacturing process which is defined that in three level:

                                                                                 

1. Physical Model:

• The Physical assets of an enterprises involved in batch manufacturing.
• Three higher level (Enterprises, site and areas) are part of the model property
• An Other four level (Process cell, unit equipment module & control module are specific equipment types.