Source: https://measuretruecolor.hunterlab.com/2012/11/05/easymatch-qc-er-software-and-fda-cfr-part-11-compliance/
Timestamp: 2017-05-25 18:15:13
Document Index: 217990066

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

How does EasyMatch QC-ER software comply with FDA 21 CFR Part 11? | Measure True Color
Posted on November 5, 2012 by Gordon	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.The issue is not about sensor conformance – HunterLab sensors such as the UltraScan PRO, UltraScan VIS, ColorQuest XE and LabScan XE are closed systems. The focus of FDA CFR Part 11 compliance is about the security of electronic records created as color measurements in software/firmware. EZMQC-ER software was developed by HunterLab to meet these needs. The “ER” stands for “Electronic Records”.
“Attachment A” describes all of the 21 CFR Part 11 requirements and HunterLab’s approach in meeting them in EasyMatch QC-ER. “About EasyMatch QC-ER” connects specific features of EasyMatch QC-ER software and the 21 CFR Part 11 requirements in Attachment A.
Share this:TwitterFacebookLike this:Like Loading...	This entry was posted in Color and Appearance Theory, EasyMatch QC-ER, Pharmaceuticals and tagged electronic records, electronic signatures, EZMQC-ER, FDA 21 CFR Part 11 ERES, IQ OQ PQ, IQOQPQ, pharma by Gordon. Bookmark the permalink.	Leave a Reply Cancel reply	Enter your comment here...