Rationale

Some of the references within the standard regarding sample sizes used to assure that the sample size is not overwhelming to the company doing the validation as well as the concept of equipment equivalency have been misinterpreted by users of the standard to utilize smaller than adequate sample sizes and not understanding the concept of equipment equivalency in the way it was intended in the current standard.  Thus, examples will be added to clarify the concepts to help users pass regulatory scrutiny.  The addition of a validation protocol template in the non-mandatory sections has also been requested.