Is that expected to record the actual results vs. expected results during validation, qualification, is FDA OKay with not recording the actual results?
No. You should have a lab notebook (which is reviewed by another chemist) with the calculations and the equipments output stapled on the page. Be sure to initial and date over this output.
View the equipment as ‘raw data’.
Your calculations as ‘intermediate data’.
Your LIMS data as the ‘final data’.
All of them must be stored properly and available to the reviewer/regulator.
Chromatograms are stored in a labelled 3-5 inch bender.
I was able to sit with the FDA and discuss this very question. What was being recorded was a check box, or “pass” only. Per the FDA auditor, it was too easy to breeze through and pencil whip the document. When someone is forced to record the actual results, they are forced to improve the quality. I think it is generally expected, although explicitely required, that you record the results and then put a Pass/Fail with an initial and date.
I agree with Boomer_Chemist above. Often these results need to be verified and revoiwed by a second person in a “witnessed by” or “reviewed by” column. This is very common in batch records and in lab procedures, and for some reason less common in validation documents (don’t know why).