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.
This 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”.
With each EasyMatch QC-ER system, HunterLab supplies a EZMQC-ER Validation and Compliance Notebook hardcopy that lists the requirements of 21 CFR Part 11 along with details on how the requirements are met by EZMQC ER software. In addition, a complete digital copy is supplied on the software CD for clients who maintain digital document libraries on conformance issues, and for use if you ever have to re-install the EasyMatch QC-ER software.
Pharmaceutical clients who wish to have their compliance department review the documentation prior to installation at their site, can search on “Validation and Compliance Notebook” at the Training & Support/User Manuals area of the HunterLab website.
Three (3) sections of the notebook are particularly useful regarding 21 CFR Part 11 compliance of EasyMatch QC-ER:
“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.
“IQOQPQ Protocols for EasyMatch QC-ER” describes the installation qualification of hardware and software; operational qualification of the installed HunterLab system and guidelines for performance qualification on the color measurement application.