EasyMatch QC ER: Compliance-compliant colorimetric software

The ER (Electronic Recordkeeping) version of HunterLabs EasyMatch QC software contains all the important additions to comply with FDA (Food Drug Administration) regulations according to 21 CFR Part 11. EasyMatch QC-ER includes a Validation and Compliance Notebook with IQ and OQ protocols and PQ templates. The software protects and manages complete and accurate records, verifies and limits access to the system, provides a computer-generated audit trail and includes an electronic signature to enable tamper-proof documentation.

21 CFR Part 11 regulates the technical and organizational requirements that must be met in order to use electronic data and documents instead of paper in development, approval and production. Since then, all sectors of the pharmaceutical and medical device industry working in FDA-regulated areas – specifically GLP (Good Laboratory Practice), GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) – are required to keep their electronic data and computer systems compliant with 21 CFR Part 11. 21 CFR Part 11 also applies to all non-US companies that manufacture products for the US market or develop products with a view to subsequent US market approval.