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John Jones wrote:
It is a PITA but if you have a properly designed environment with
separate test & prod systems/partitions then you have the infrastructure
needed to do ChgMgt properly.
And mostly it's documenting things and making sure people don't make
changes they aren't supposed to make.
This is particularly true if your company (in this case, my client) is subject to FDA
regulations. The FDA requires that you 'validate' your system any time that changes are
made, and that equipment, software, and user documentation and training follow their
standards, as well as your own internal SOP's.
The validation process is very labor-intensive and time-consuming, and requires that in
addition to development and QA environments, you have a Validation environment which is a
copy of the production environment where you test the changes for validation purposes.
So, in addition to having a good change management system (we use MKS Integrity Manager
and Implementer - a little plug for our list owner's employer) you must also document that
the changes made conform with the FDA's validation requirements. Likewise, there is are
international and EU standards for validation that must also be followed if you are doing
business outside the U.S.
- sjl
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