4 ms·

As someone who has been on the receiving end of several FDA audits, I would really like to know on what basis you're saying all of this, because everything in m

As someone who has been on the receiving end of several FDA audits, I would really like to know on what basis you're saying all of this, because everything in my 10 years of experience of doing this is contrary to what you've said.

jordigh 10y ago
Maybe we worked in different fields? I only did 3 years, only received one FDA audit, but many other audits from pharmaceutical companies. I was in the more diagnostic side, not therapeutic, although we did have some safety checks where we had to quickly raise an alarm if our analysis showed a potential medical emergency. Did the FDA actually check your software or just your documentation? Did the auditors very carefully grill you or just languidly ticked off boxes on a form? Did you find the process of writing documentation instrumental in ensuring that your software was carefully tested? Did you ensure that your tests were reproducible and comprehensive? None of these things were done very carefully in our case. My superiors were very insistent on the documentation and were quite proud of the quality of our software but they mostly never had any interaction with it and had no real idea of what we did for software validation. They were more concerned with making sure signatures and dates were correct and that our documentation didn't make us look bad. I think the audits must look more impressive when you're in charge, but as the one actually writing the software I was thinking... that's it? The FDA doesn't really give a damn about what I really worked on, do they?
- seehafer 10y ago
  > Maybe we worked in different fields? Class III devices (pacemakers, deep brain stimulators, insulin pumps) > Did the FDA actually check your software or just your documentation? In a submission, occasionally. In an audit, it depended on the nature of an audit. I've been part of one audit that was due to persistent SW failure and yes, they checked code. > Did you find the process of writing documentation instrumental in ensuring that your software was carefully tested? No, but that's not really the point of documentation. > Did you ensure that your tests were reproducible and comprehensive? Yes, we could kill people if we screwed something up. > They were more concerned with making sure signatures and dates were correct and that our documentation didn't make us look bad. This practice is common, I grant. Doesn't mean it's universal or right. > The FDA doesn't really give a damn about what I really worked on, do they? FDA heavily triages activity based on risk. If your product is life-sustaining they will definitely be all up in your business.

jordigh 10y ago

Maybe we worked in different fields? I only did 3 years, only received one FDA audit, but many other audits from pharmaceutical companies. I was in the more diagnostic side, not therapeutic, although we did have some safety checks where we had to quickly raise an alarm if our analysis showed a potential medical emergency. Did the FDA actually check your software or just your documentation? Did the auditors very carefully grill you or just languidly ticked off boxes on a form? Did you find the process of writing documentation instrumental in ensuring that your software was carefully tested? Did you ensure that your tests were reproducible and comprehensive? None of these things were done very carefully in our case. My superiors were very insistent on the documentation and were quite proud of the quality of our software but they mostly never had any interaction with it and had no real idea of what we did for software validation. They were more concerned with making sure signatures and dates were correct and that our documentation didn't make us look bad. I think the audits must look more impressive when you're in charge, but as the one actually writing the software I was thinking... that's it? The FDA doesn't really give a damn about what I really worked on, do they?

seehafer 10y ago
> Maybe we worked in different fields? Class III devices (pacemakers, deep brain stimulators, insulin pumps) > Did the FDA actually check your software or just your documentation? In a submission, occasionally. In an audit, it depended on the nature of an audit. I've been part of one audit that was due to persistent SW failure and yes, they checked code. > Did you find the process of writing documentation instrumental in ensuring that your software was carefully tested? No, but that's not really the point of documentation. > Did you ensure that your tests were reproducible and comprehensive? Yes, we could kill people if we screwed something up. > They were more concerned with making sure signatures and dates were correct and that our documentation didn't make us look bad. This practice is common, I grant. Doesn't mean it's universal or right. > The FDA doesn't really give a damn about what I really worked on, do they? FDA heavily triages activity based on risk. If your product is life-sustaining they will definitely be all up in your business.