How are IQ OQ PQ protocols applied to stand-alone ColorFlex EZ and MiniScan EZ instruments?

Here is how to think of IQ OQ PQ being applied in general for all HunterLab instruments. Continue reading

How does EasyMatch QC-ER software comply with FDA 21 CFR Part 11?

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

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

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How can I certify HunterLab EZMQC-ER software and instruments to FDA 21 CFR Part 11 ERES?

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