Our engineering group just recently retired a piece of equipment that was currently on our Master Validation Plan gap list. This piece of equipment was making product that never had the software validated. In addition, it was identified that the equipment also needed cleaning validation, which was never conducted. We do not plan on using this equipment again.
My question is from a compliance side, is there something we should do? For example a memo to file stating that the equipment made good product and it has no risk for both cleaning and software?
Also, this piece of equipment did have equipment qualification performed but neither cleaning or software validation was involved in that.
Any advice would be greatly appreciated! Thanks!
My question is from a compliance side, is there something we should do? For example a memo to file stating that the equipment made good product and it has no risk for both cleaning and software?
Also, this piece of equipment did have equipment qualification performed but neither cleaning or software validation was involved in that.
Any advice would be greatly appreciated! Thanks!