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 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