My company like many others have initiated a lot of lean manufacturing initiatives in the last couple of years and are now looking to install a downtime management system on their packaging lines.
My concern is that, currently, our downtime is recorded in our manufacturing record and as such forms part of the overall batch record. My initial thoughts were that as a result, the system should be validated. But now i am having second thoughts, is downtime a GMP record (it is not listed in the GMP guide as a record that must be kept from a GMP viewpoint). Therefore, my query is do i have to validate such a system. I firmly believe that if i dont then i must have a good case documented for my decision.
I dont envisage any risk to product if i dont validate this system, one important point is that the system will print out a report (a log of downtimes) which will be signed by production and added to the batch record so it is not an electronic record either.
Anyone have any thoughts?