FDA Aspects - No Improvements to 12 Year Old Software

new_to_this

Involved In Discussions
#1
Before I start this job for this company there was a person pretty much put on CMM without any experience and started learning on his own and started writing programs. I give him lots of credits because it's not easy to start learning PCDMIS. Now 4 years later we run same jobs again and they want me to run same programs. I know they are wrong they need to be rewrote from scratch, but I can?t do anything about it because I guess per FDA, improvements are not on the menu. Even myself I would never run programs that I wrote 12 years ago because I know I made some unintentional mistakes and as I learned on my mistakes I improved my programming skills with over13 years experience.
How do I run programs that I know are not correct? Any suggestions, what to do? I would appreciate your inputs. Thanks!!!
 
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yodon

Staff member
Super Moderator
#2
Why would you say "per FDA, improvements are not on the menu"?

My next question is why do you think the programs written 12 years ago are bad? What's specifically not correct?

It may well be the case that they are wrong but just because they're 'old' doesn't mean they're wrong.

Presumably, your company should have some kind of change management process - either through the CAPA system or otherwise. You should be able to raise the issue through whatever mechanism that is and take necessary corrections.
 

new_to_this

Involved In Discussions
#3
Yodon,
First I would like clarify something. My original topic was: "FDA no improvements?"
I don't know how and who edited "FDA no improvement for 12 Year Old Software".
I never said that programs written 12 years ago are bad. I said it as an example if I have to run programs that I wrote 12 years ago I would rewrite them now because I learn a lot since then and i am sure I made some unintentional mistakes that time.
You can write program and because it will run it doesn't mean is correct.
You can write manual program with all kind of manual hits and all kind of incorrect alignments, it's still program. And you can write fully DCC mode with correct alignments and that is program too.
Programs that I am talking about are incorrect because alignments are wrong, scanning is wrong, labeling is wrong etc. Programs were never validated.
As far as improvements I was told that per FDA regulations you are not required to show improvements like ISO 17025, that’s the reason I put question mark on the and of the topic-"FDA no Improvements?".
Even if the program is correct but if you can make improvements to eliminate operator error and reduce the run time, reduce the set up time and still correlate with different measuring methods why you still have to use the old program?
I thought there is maybe way that we can write our own procedure to eliminate all the waiting from request to program change and getting all the signitures...etc. Thanks for your reply I greatly appreciate it.
 

yodon

Staff member
Super Moderator
#4
Even if the program is correct but if you can make improvements to eliminate operator error and reduce the run time, reduce the set up time and still correlate with different measuring methods why you still have to use the old program?
The QSR (21 CFR 820) does include "CAPA" so preventive actions / improvements are definitely covered. There does come a point where business decisions have to be made. Will the benefits gained from the improvements (both business and patient safety considered) outweigh the cost of making the improvements? To make such changes would require (most likely) a re-validation of that system so it's by no means a simple process. If, for example, you prevent 1 error in 1 million and that error is caught in subsequent inspections AND the error poses no risk to patient safety then it's probably not worth it. If, though, the change prevents an otherwise undetected error that could pose a risk to human safety in the field, then actions are probably warranted.

I would suggest that you elevate it to the management team, indicating what errors would be prevented and the benefits of making the change. Now if the management team is not receptive to considering the idea, you may have bigger issues. :) Good luck!!
 
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