Given the fact that most of the systems needing to be compliant are usually found not to be compliant and are usually replaced, does it make sense to do a gap analysis or go directly to remediation?
Some feel that since most systems that have been assessed by gap analyses in the past have turned out to be non-compliant with Part 11, it would save time and money to not do a gap analysis. Like all compliance decisions that an organization must make, this is a personal one. The overall goal is to achieve compliance with Part 11 for applicable systems in order to provide reliability and trustworthiness for the ERES generated/managed by those systems. How you get there is not regulated. Perhaps future FDA Part11 guidance documents will comment on the 'no gap analysis' methodology??