Here is how to think of IQ OQ PQ being applied in general for all HunterLab instruments. Continue reading
How are IQ OQ PQ protocols applied to stand-alone ColorFlex EZ and MiniScan EZ instruments?
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Here is how to think of IQ OQ PQ being applied in general for all HunterLab instruments. Continue reading
There are several parts to the 21 CFR Part 11 documents with a good overview of 21 CFR Part 11 at the US FDA website. Part C is the key section concerned with electronic records retention. Continue reading
FAQ: “ Is there anything that documents (certifies) that HunterLab EasyMatch QC-ER software and instruments conform to FDA 21 CFR Part 11 electronic records, electronic signatures (ERES)?” Continue reading