More on what hedra has to say (she and I work for the same company, in diffent roles).
Validated software, hardware, and processes allow an auditing agency (could be the FDA/Pharma, but it’s also applicable in chemical manufacturing, Law, Financial/Fiscal, etc) to verify that:
- Things are done in a standard fashion,
- That the ‘standard fashion’ is trackable (who did what, when),
- That the standard fashion is appropriate to the task at hand,
- That the ‘standard fashion’ does what it claims, and nothing else,
- That the ‘standard fashion’ has no undocumented work-arounds,
- That the ‘standard fashion’ would not ‘break’ under any forseeable strains or pressures,
- That ‘standard software’ is stable and well understood,
- That the ‘standard software’ does not alter information in any unplanned and controlled fashion,
- That if the ‘standard software’ should fail, that event is captured and reported,
- That emergency recovery schemes are robust, well-planned, feasable, and appropriate,
- That the hardware will work with all the software, and that various software packages work well with each other and the hardware in any validated configuration,
- That the hardware does not change, in any unexpected fashion the information it proccesses,
- That the ‘standard hardware’ is reliable, robust, and fault-tollerant…
The list goes on for volumes.
One small example: I helped put together a nifty little hack that filled a technology gap as a client was shifting from one process to another. It took a week and a bit to put the app together, and it was a simple process (although the code wasn’t quite so simple). For a tool that was planned to last in production for less than six months, filled exactly one role, did exactly one thing, my team spent 5 additional weeks validating it. We killed a small forest-worth of trees on documentation, too. Now that it’s going into full-scale production, we’ll kill a few more trees updating the validation, but it’ll only take a week or two to complete the process.
One of the nice things about validated systems, software, and processes: Once it’s validated, it’s easier to maintain, and changes are easy to track and document.