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FDA 21 CFR Part 11 software for Colour Measurement

As the leader in Industrial colour measurement, HunterLab have always maintained a version of FDA 21 CFR Part 11 compliant software mainly provided to our pharmaceutical customers.

EasyMatch QC software is available with Electronic Record Keeping capability and meets the software requirements for 21 CFR Part 11 compliance. This version of the software protects and maintains complete and accurate records, limits system access, performs authority cheques, provides a computer-generated audit trail and includes electronic signature.

The EasyMatch QC-ER Validation and Compliance Notebook include:

Setting Up Your Windows System

About EasyMatch QC-Electronic Records

Instrument Installation Qualification (IQ) Protocol

Operation Qualification (OQ) Protocol

Performance Qualification (PQ) Protocol

System Validation Checklist

Establishing Standards Operating Procedures (SOPs)

CFR Documents

Glossary of Terms

If you have a requirement for colour measurement in your laboratory or manufacturing facility and would like to discuss how the EasyMatch QC-ER software is suitable please contact our sensors team and they will be able to provide you with useful documentation to show how compliance is achieved.

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