Downtime Management System -Validate?

COMPUTER SYSTEM VALIDATION (CSV)
1

Hi,
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?

alitoast

2

Hi,

If it’s in your batch doc then it must be validated as you are submitting the data to a regulatory agency.

Why do you (as a company) stick that sort of info in a batch doc? The only reason I can immediately think of for including it is if something in your packaging process is time critical e.g. you thermoform on a continuous basis and have qualified the former upon continuous operation and have no reject function on the lines for material which has sat on the forming station too long? Far fetched I know, but it does seem very odd that this info would go into a batch doc.

Cheers

Monkey

3

[quote=Alitoast]Hi,
our downtime is recorded in our manufacturing record and as such forms part of the overall batch record.
Anyone have any thoughts?
alitoast[/quote]

Hi Ali

There must be a reason why downtime is recorded. If so why? If it is important it should be validated.

Regards,

Tony