I have a question regarding the qualification of an pH/Conductivity meter.
The dual channel meter has no possibility to print directly the measured value.
The only way to get a print out is to save the measured value.
To save a measured value means that I generate an e-records. The dual channel meter has the possibility to save 500 measurements.
Have you deal with that situation?
A CSV according Annex 11 makes no sense for that kind of equipment! What about 21 CFR Part 11!?
The requirements for e - records!?
Anyone have a suggestion how to avoid a CSV! Or how you deal with this kind of equipment!?
Thanks for your efforts.
typically pH meters are calibrated. If you want to use saving function you would have to govern it procedurally since you don’t seem to have Part 11 compliant software. I hope this makes sense. Also never say that you want to avoid something. We are not in this industry to avoid things. 
You can write a IOQ (make it simple). Write your observations in a lab note and have it reviewed by a 2nd chemist. Of course the software must be 21 CFR part 11 compliant (assuming no electronic signatures required).
How is the data saved? You may need to put controls around that process. For example, if it exports a CSV file to Windows, then you would put controls around the Windows Environment to ensure the integrity of the file. This could be a combination of security settings and Windows policies.
Stepping back though, what is the process for using the meter? Are you taking manual readings, and is saving the data even necessary? Typically electronic records only apply if you are relying on that data. But if your process is manual this won’t apply even if the feature is there.
I hope that helps a little.
One option is to record the value immediately. Agreed, this is proceduralized. That way there is no e-signature to worry about, and there is no requirement for data archival or retrieval (part of the 21 CFR part 11 compliance).
This is allowable, and is comparable to other simple instruments (a calibrated thermometer for example, or a stop watch) which show a value, which is recorded, but do not store/print data.
Although an instrument can do something (store data) sometimes validating that feature is more hassle than it is worth. You just have to state what the instrument is used for, and what it cannot do (although it is physically able).
I would perform Compliance Determination b4 proceeding to any validation activities … and the determination will consist of 3 parts - 1. GxP compliance, 2. GAMP 5 Software Category and 3. ERES.
There are list of questions you can use in your determination e.g. for GxP if the data use for regulatory submission and etc. ERES e.g.Does the system create, modify, maintain, archive, retrieve or transmit electronic records specifically required by any GxP regulation?. Identify the software category is important to know the validation efforts. The Compliance Determination will give you a good start for the validation, most cases u will filter out many unnecessary works and hit the right objectives.
Hope it helps … 
but dun try to avoid things…ta
Thanks to all for your response.
Ok, let me try to clarify ! Im not a native speaker… so sorry for that. Relax, I do not want to avoid anything. Patient Safety is High level and my intention.
A calibration will be performed. The main issue is, that the departmen bought an pH/Conductivity Meter which will save automatically the measured values. A print out wothout saving is not possible.
My question is: How can I perform a commissioning or qualification or how will be the argument to qualified it simple / smart event though e records are present.
I hope now it is a little bit mor clearly.
Thanks
It sounds like you have three options
1 - Record the data manually (do not use the print-out, do not use the e-data). This is the simplest.
2 - Use the e-data, and somehow validate the transfer of data to archive. This should be in an SOP, and be tested in a validation protocol. Remember this data must be secure, and will follow what tangtin_ing has recommended (this is not a quick fix, and requires a bit more expertise that you can likely get via a question in a forum, rather you’ll need to do some reading of GAMP or else get a consultant. (I wish the answer was quicker than this, but there are full books dedicated to how this is to be done).
3 - Print out the data (which you stated you cannot do), and affix it to whatever report it goes with. Head up the print-out also requires some sort of verification that data is successfully printed out (without error).
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Thanks you guys for the comments. I really enjoyed it.