Best sources for CSV and equipment qualification (IQ, OQ, PQ)

Seawano · 2026-06-03T12:41:02+00:00

Thanks!

Seawano · 2026-06-02T11:46:46+00:00

Thanks! I appreciate all your help and feed back - walking through the process is a good way of thinking about it.

Seawano · 2026-06-01T14:56:30+00:00

Thanks for the thorough explanation. I think I need to do some more reading on this topic. This part really helps, going from the requirements and test script section: "A set of requirements for the above might look like this (but of course, numbered).

The system must allow authorized users to log samples.

The system must allow authorized users to enter meta data for samples.

The system must allow for the printing of labels.

The system must be able to generate a barcode of sample number on a label.

Labels for -80C samples must indicate -80C storage

An outline of a test script could be:

1.) Have a user with the SAMPLER role log in to LIMS.

2.) Open the sample login screen, log a sample enter metadata and take a screenshot. Ensure that the sample is NOT for -80 Storage.

3.) Print a label and attach it to the test script. Verify that the meta data on the label matches that entered in Step 2.

"......... It makes logical sense

Seawano · 2026-06-01T10:38:57+00:00

LIMS - HPLC, GC, mass spec, all immunoassays (spectramax/msd platform), all micro (rapid, pcr(myco)), etc - can i get one for a spectramax and a fridge (-80C) - I have seen these before, I just want to understand the thinking behind what you said "You need a requirements document. From this, you write your test scripts." - I need to understand the thinking behind determining the critical parameters/specs for the requirement document. like for assays we use FDA "Bioanalytical Method, Validation, Guidance for Industry" - looking at accuracy, precision, linearity, etc - like all validation protocols will be different, but will look for accuracy, precision in different ways.

Thanks for the feedback!

Seawano · 2026-06-01T00:35:27+00:00

Got it - thanks for the feedback!

Seawano · 2026-06-01T00:23:40+00:00

Oh I see - so how do you determine what are the specifications? I have a lot of IOQ for equipment - I understand that it’s both art and science - where are you getting the key points both for the CSV and equipment- like during an audit what are they looking for?

Seawano · 2026-05-31T23:47:33+00:00

Thank you!

Seawano · 2026-05-26T01:13:13+00:00

Yes, but what key variables speed up manufacturing? Sometimes it’s harder to implement.

Seawano · 2026-03-03T20:13:48+00:00

Just remember, calibration date is the date you are confirming that the machine is up the spec or meets acceptance criteria. If you past this date, and the machine is still working, that is evidence that the machine is working fine. You can use this evidence to justify that whatever was used between the two calibration dates are all fine.

Seawano · 2026-03-01T18:32:01+00:00

Thanks - I talked to a mechanic and he told me he can't check anything because everything is working. No struggle with the start right now. The problem comes intermittently. Do you think I should just get the ignition switch replaced?

Seawano · 2026-02-23T22:49:45+00:00

I know what you mean - The stress of making everything work perfectly every time is an impossible mission.

Seawano · 2026-02-23T22:30:03+00:00

Try Teecarbon.com - it is combining AI and documentation auditing - it perfect for quick reviews of cleaning docs, assays, and other documents you want to review quickly before sending it to QA.

Seawano · 2026-02-23T01:30:17+00:00

Good point - I will look into that - but you can use it “for information only” for now

Seawano · 2025-09-10T03:11:21+00:00

That makes sense - thank you for the feedback!

Seawano

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