Hi all. I would like to know how often I should perform a validation review on both qualified and unqualified but controlled legacy systems. Our policy is every 2 years if no change controls have been logged for a qualified system, but it is still a bit vague for legacy systems. Any input would be appreciated.
Review of the legacy system to prove that they are still in a validated state?
Unless the equipment is soo old that there are many changes being done to it to keep it GxP compliant, you could perform some form of impact/risk assesment and decrease the time between reviews on legacy equipment only.
But then again, if your systems are in a state of control, you have full confidence in your QA system and your VMP states every 2 years (or SOP), then legacy or not, a 2 year review period for both would be acceptable.
i’m not too concerned about already validated legacy systems. My issue is around older, existing systems, with no qualification records, which have been maintained in a controlled state. That is to say, there is strong compliance history associated with it