Ok, showing how dumb we can all be some times. I tried this after my son was born. We started sterilizing his bottles using a steamer in the microwave. Well, I figured it would be just as effective for sponges! Let's face it, those kitchen sponges get really smelly and nasty after a while - no matter what they say about "germicidal". Unfortunately, I also tried it w/ a not-completely-wet sponge. Damp won't do it, the thing has to be SOAKING wet. I put a damp one in there for 2 minutes - enough time to boil water - and burned a hole right through the middle of it.
Now, thanks to HIGH-TECH RESEARCH (I'm embarrassed to say it's my alma mater) I know that if I soak the thing, it actually DOES kill the germs!
I work in the Pharma industry as well, and have some experience with validated systems - along with the associated regulations. CFR 21 Part 11 is the pertinent regulation for any and all pharmaceutical data systems - whether used for clinical trials or other cGMP purposes.
In a nutshell, it says nothing about an ISO 9000 requirement - that's SPECIFICALLY your company's policy. I understand why, it's the same deal as Sarbanes-Oxley compliance - they use ISO 9000 standard as the benchmark on which they make their rules, so following ISO 9000 means you'll meet compliance guidelines for process documentation and control on your data systems. It's also used as the standard for physical equipment manufacturing for pharma use, so more than likely one of your Quality guys knows about that, and figured "Hey, it's software manufacturing, and manufacturing means ISO 9000! Done!"
If you're going to use open-source software, you'll need to demonstrate to Quality that you can meet the guidelines for CFR 21 Part 11. I apologize for missing the name of the person who posted saying "act like it's your code" - but they're right. The key is good change management practice. If you use it and the company that makes it doesn't meet your Quality standards, then you need to take the source, review it, compile it yourself, test it extensively with the other applications you'll use on the same infrastructure.
And, every time you upgrade, you'll need to diff the source, document it, and compile and test again. The real deal is that it's your own Quality group setting the standard here, the FDA just wants you to show you have control, and have taken every precaution to avoid negative impact. Good luck!
*joke* I hear they're going to be testing this in the near future on a Chevy Corvette. (Original plans were for a Pontiac Firebird, but that model was discontinued during development, so an alternative GM sports car was selected.) Long-term plans for the vehicle include military applications, however civillian law-enforcement has also been discussed. Vigilante testing has proven successful, but met with mixed approval. K.I.T.T. pilot, David Hasselhoff was unavailable for comment.:)
Ok, so Mr. Cruz here is probably going to have a big chunk of his tuition covered once he gets through with the lawsuits against the police officer(s) who arrested him - provided he was just taking pictures, and not video w/ sound.
The guy (Gannon?) from NH however, is going to have a problem. The problem isn't the VIDEO - in fact, you can video ANYONE visible outside, pretty much at any time. Truth is, if you can get a clean shot thru somebody's window, you can probably get away with it. AUDIO on the other hand, is a different ballgame entirely.
The guy in NH was recording both VIDEO & AUDIO on his cameras. Now, the way the federal, and most state wiretapping laws work, if you're audio-recording a conversation, SOMEBODY INVOLVED IN THE CONVERSATION HAS TO KNOW ABOUT IT. So, if you're recording a conversation you have w/ someone, you're OK (you know about it, and you're involved). BUT, if you're recording people who DON'T know, that's illegal - so if ANYONE walking by the NH guy's cameras was recorded, and wasn't talking to him, or his wife, or somebody who actually knew they were being recorded, he's going to jail.
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Ok, showing how dumb we can all be some times. I tried this after my son was born. We started sterilizing his bottles using a steamer in the microwave. Well, I figured it would be just as effective for sponges! Let's face it, those kitchen sponges get really smelly and nasty after a while - no matter what they say about "germicidal". Unfortunately, I also tried it w/ a not-completely-wet sponge. Damp won't do it, the thing has to be SOAKING wet. I put a damp one in there for 2 minutes - enough time to boil water - and burned a hole right through the middle of it. Now, thanks to HIGH-TECH RESEARCH (I'm embarrassed to say it's my alma mater) I know that if I soak the thing, it actually DOES kill the germs!
I work in the Pharma industry as well, and have some experience with validated systems - along with the associated regulations. CFR 21 Part 11 is the pertinent regulation for any and all pharmaceutical data systems - whether used for clinical trials or other cGMP purposes.
In a nutshell, it says nothing about an ISO 9000 requirement - that's SPECIFICALLY your company's policy. I understand why, it's the same deal as Sarbanes-Oxley compliance - they use ISO 9000 standard as the benchmark on which they make their rules, so following ISO 9000 means you'll meet compliance guidelines for process documentation and control on your data systems. It's also used as the standard for physical equipment manufacturing for pharma use, so more than likely one of your Quality guys knows about that, and figured "Hey, it's software manufacturing, and manufacturing means ISO 9000! Done!"
If you're going to use open-source software, you'll need to demonstrate to Quality that you can meet the guidelines for CFR 21 Part 11. I apologize for missing the name of the person who posted saying "act like it's your code" - but they're right. The key is good change management practice. If you use it and the company that makes it doesn't meet your Quality standards, then you need to take the source, review it, compile it yourself, test it extensively with the other applications you'll use on the same infrastructure.
And, every time you upgrade, you'll need to diff the source, document it, and compile and test again. The real deal is that it's your own Quality group setting the standard here, the FDA just wants you to show you have control, and have taken every precaution to avoid negative impact. Good luck!
*joke* I hear they're going to be testing this in the near future on a Chevy Corvette. (Original plans were for a Pontiac Firebird, but that model was discontinued during development, so an alternative GM sports car was selected.) Long-term plans for the vehicle include military applications, however civillian law-enforcement has also been discussed. Vigilante testing has proven successful, but met with mixed approval. K.I.T.T. pilot, David Hasselhoff was unavailable for comment. :)
Ok, so Mr. Cruz here is probably going to have a big chunk of his tuition covered once he gets through with the lawsuits against the police officer(s) who arrested him - provided he was just taking pictures, and not video w/ sound.
The guy (Gannon?) from NH however, is going to have a problem. The problem isn't the VIDEO - in fact, you can video ANYONE visible outside, pretty much at any time. Truth is, if you can get a clean shot thru somebody's window, you can probably get away with it. AUDIO on the other hand, is a different ballgame entirely.
The guy in NH was recording both VIDEO & AUDIO on his cameras. Now, the way the federal, and most state wiretapping laws work, if you're audio-recording a conversation, SOMEBODY INVOLVED IN THE CONVERSATION HAS TO KNOW ABOUT IT. So, if you're recording a conversation you have w/ someone, you're OK (you know about it, and you're involved). BUT, if you're recording people who DON'T know, that's illegal - so if ANYONE walking by the NH guy's cameras was recorded, and wasn't talking to him, or his wife, or somebody who actually knew they were being recorded, he's going to jail.