I work for a medical device company in IT Quality and we have a number of systems that no longer have any transactions running against them, but they cannot be completely decommissioned due to historical data requirements. Has anyone ever had to write a document/plan/report, etc. detailing that the system is no longer in use, but will be read only until end of life (in our case, I’ll be long dead and gone by then LOL):D…I am having trouble finding any template or example of this scenario and wondered if anyone out there might have an idea for me?
Thanks in advance,
Hi Christy,
Interesting question, this would involve generating a retirement plan for your current system. I myself have not done this before but I’d imagine some of our members have gone through this before and could provide some valuable insight.
I’d imagine the following would have to be performed as part of the documentation
-Reason the system is being retired
-Scope of the retirement
-What type of information does it contain
-How long does this infomation need to be retained
-What system is replacing the old system
-How is this going to happen
-Will there be an implementation to the new system, in assocaition with the old system
-Hardware requirments of the old system
-Support for the old system
-Data retriveability
-System Owner
Overall I would look at this logically and generate a plan to suit your own system. I will research this further tomorrow and come up with more suggestions.
Hopefully other members will have more experienced feedback
Regards
Graham;
Thanks for the quick reply-I was thinking I might have to wing it on this one, so your list is very much appreciated! I always get the “well, we don’t know, so give it to her to figure out” assignments here :eek: Thanks again!
No problem, its usually the way these things work!
Hi Christy
I am currently assisting a medical device company with preparing for an impending FDA inspection and have got similar problems. The way I have addressed this is be creating a system description for each of the systems, which gives an opportunity to place some background information on the history of the system and to summarise its current status. The SD (System Description) is now a document recommended in GAMP 5 for computer systems. If you create one and get it approved, I would have thought that this would suffice.
If the systems have been replaced by newer systems, then the old system could be included within the SD for the new system.
At some point in time, the data will have to be migrated or converted to a different format as the system will become unsupportable in the future.
Let me know if you would like any further information on SD.
Cheers
Jon
J M J Davey
Managing Director
T: ++44 (0) 1482 650514
M: ++44 (0)7738 423627
www.provalidus.com
Thanks Jon for the information; the new applications have been running for almost a year now, so it is a case of just getting it documented correctly that the original system isn’t being used. The new application System Design Document did have the information about the new application being used to replace the old one, and we currently use a windows based emulator to get to data on the old mainframe system.
Cheers,
Christy Buckley