We have been operating on a single instance of SAP since we initially implemented it over 15 years ago. However, recently we have undergone some organizational changes and now have a portion of our business in the healthcare sector (10-15%). What we've found is that there are different compliance requirements from the FDA related to performing CSVs (Computer System Validations). These system-wide tests can be rigorous and may be required more frequently than we are accustomed to and for changes which we would not have previously required it. So because our business units share an instance of SAP, implementing more rigorous system testing could slow-down our ability to adapt the system for other businesses. We currently implement approximately 250 transports a month without a regimented release management strategy.
We're weighing our options of remaining on a single instance and keeping our TCO to a minimum, vs. creating a separate instance for healthcare which can be governed separately, but then will need to be re-integrated and will subsequently increase TCO.
Has anyone encountered a similar situation or can offer guidance?