ALS Method of Validation
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ccorbello
- Posts: 1
- Joined: Wed Jan 27, 2021 8:45 am
ALS Method of Validation
We bought a Crime-Lite ML2 and this is the first time we have an ALS that needs a Method of Validation done. The previous one was over 15 years old. Does anyone have a method that I can look at to get an idea of where to start? It doesn't have to be the same light. Just something so I'm not trying to reinvent the wheel. I'm in the process of contacting different agencies, but I thought I'd try here as well. Thanks in advance.
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josher89
- Posts: 509
- Joined: Mon Aug 21, 2006 10:32 pm
- Location: NE USA
Re: ALS Method of Validation
Do you need to validate the light source or do a performance verification that it is actually working? Often, validation is the 'go-to' when it comes to getting a new product but in a lot of cases, a simple performance verification is all that is needed. This is a presumptive test, right? If something fluoresces after you shine the light source on it, you're not conclusively saying it's semen or whatever. You will just focus on those areas for swabbing or other testing.
If you look at it from that perspective, a known semen sample would be all that is needed. Shine the light at the sample and if you observe glowing, you're golden. Again, we're not measuring the amount of "glow" (fluorescence), just an observation if you see it.
Same with a lot of processing techniques. A performance verification is, in most cases, all that is needed to confirm that it's working as designed.
If you are using an instrument to get quantifiable data, that's where validation might be necessary.
IMHO, anyway and how I articulate it to my QAM.
If you look at it from that perspective, a known semen sample would be all that is needed. Shine the light at the sample and if you observe glowing, you're golden. Again, we're not measuring the amount of "glow" (fluorescence), just an observation if you see it.
Same with a lot of processing techniques. A performance verification is, in most cases, all that is needed to confirm that it's working as designed.
If you are using an instrument to get quantifiable data, that's where validation might be necessary.
IMHO, anyway and how I articulate it to my QAM.
"...he wrapped himself in quotations—as a beggar would enfold himself in the purple of emperors." - R. Kipling, 1893
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SConner
- Posts: 145
- Joined: Wed Mar 04, 2009 11:06 am
Re: ALS Method of Validation
What Josher89 said. Unless it's an entirely new technology, procedure, process, or method you shouldn't have to do an entire "validation". All that should be required is a performance check or verification, whatever your lab feels like calling the procedure to confirm that a new piece of equipment using an existing method is compatible and meets the needs for the method.