EasyMatch QC ER

EasyMatch QC ER: Compliance-compliant colorimetry software

Color measurement according to FDA 21 CFR Part 11 for GxP regulated companies

The validation of processes within quality assurance in the pharmaceutical industry is an essential part of Good Manufacturing Practice (GMP). HunterLab helps customers validate their HunterLab devices and equipment to meet regulatory compliance. Automated software solutions, printed validation and compliance manuals, customized performance qualifications, as well as on-site installation and training guarantee compliance with regulations.
YOUR BENEFITS AT A GLANCE

ER software for laboratory & production

Authorization

Validated user login for each authorized user

Logs

Audit trail and event log allow for a fully secured system

E-Signaturen

Signatory must log in each time.

Validation & Compliance Notebook

Printed notebook for documenting the IQ, OQ and PQ protocols

Secure database

Deletion of data or manipulation not possible.

training

Installation and training possible on site or via online help.

Learn more...

Whitepaper

"Color measurement according to 21 CFR Part 11"

Find out more about electronic record keeping and the creation of a digital qualification notebook in our new white paper.

KF 25 - URL /easymatch-qc-er WP

Secure color data management.

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 maintains complete and accurate records, audits and limits access to the system, provides a computer-generated audit trail, and includes an electronic signature to enable non-tamperable documentation.

The EasyMatch QC-ER software includes:

SECTION 1: 21 CFR PART 11 COMPLIANCE

    What is CFR 21 Part 11How does HunterLab help a company be compliantPredicate RulesWindows System Set-up Definitions

SECTION 2: IQ/OQ/PQ PROTOCOLS

    System overviewOverview of qualification protocolsIQ (Installation Qualification) protocols for hardware and softwareOQ (Operational Qualification) protocolsPQ (Performance Qualification) protocols

What is 21 CFR Part 11?

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 that work in FDA-regulated areas - specifically GLP (Good Laboratory Practice), GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) - have been required to comply with 21 CFR Part 11 compliant. 21 CFR Part 11 also applies to all non-US companies that manufacture products for the American market or develop products with a view to subsequent US market approval.

Still questions? Gladly!

Contact your HunterLab sales team. We are there for you and will advise you on your application:

49 8841 9464 Send e-mail
Additional Information:
Overview of measuring devices laboratory & production
EasyMatch QC brochure
Article EP color number determination Whitepaper 21 CFR Part 11

INQUIRY or ADVICE

Would you like an offer or advice? Send us your details and we will get back to you as quickly as possible.

KF 24 - URL /easymatch-qc-er

Share by: