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)?There is a subtle but important point here. Software or hardware cannot be certified as being FDA 21 CFR Part 11 ERES compliant as compliance goes beyond software to include features of the operating system configuration as well as measurement method implementation by the user. For this reason HunterLab does not have a specific document that states the software or hardware is inherently 21 CFR Part 11 compliant.

What we do provide is a combination which is better – EasyMatch QC-ER Electronic Records software, an appropriate sensor, hardware security key and a complete 21 CFR Part 11 Validation and Compliance Notebook.  The notebook:

  • Describes how special features of EZMQC-ER meet the specific requirements of FDA 21 CFR Part 11 ERES.
  • Describes how the Windows operating system should be configured to assist EZMQC-ER in being CFR Part 11 compliant.
  • Describes how EZMQC-ER needs to be installed and configured to be 21 CFR Part 11 compliant.
  • Provides the necessary IQ/OQ/PQ protocols associated with the User product measurements that support 21 CFR Part 11 compliance.
  • Provides a validation protocol allowing the User to self-certify the 21 CFR Part 11 compliance of product color measurements made on HunterLab equipment using EZMQC-ER software.

FAQ: “Is there any certification from FDA regarding compliance of the HunterLab EasyMatch QC ER software to 21-CFR Part 11?”

The US Federal Drug Administration does not certify software compliance. Instead the FDA defines the 21 CFR Part 11 requirements and HunterLab as an ER software manufacturer describes how these requirements are met. This is done in Appendix A and “About EasyMatch QC-ER” section in the EZMQC-ER Validation and Compliance Notebook.

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