EasyMatch QC ER: Compliance-compliant spectrophotometric software

Color measurement according to FDA 21 CFR Part 11 for GxP regulated companies
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 requirements. Automated software solutions, printed validation and compliance manuals, customized performance qualifications, as well as on-site installation and training guarantee compliance with regulations.

Your advantages at a glance

ER software for laboratory & production
  • Authorization

    Validated user login for each authorized user

  • E-signatures

    Signatory must log in each time.

  • Secure database

    Deletion of data or manipulation not possible.

EasyMatch QC
  • Logs

    Audit trail and event log allows a fully secured system

  • Validation & Compliance Notebook

    Printed notebook for documentation of IQ, OQ and PQ protocols

  • Training

    Installation and training possible on site or via online help.

Whitepaper-color-measurement-by-21-CFR-Part-11

Whitepaper "Color measurement according to 21 CFR Part 11"

Learn more...

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

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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 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.

The EasyMatch QC-ER software includes:

SECTION 1: 21 CFR PART 11 COMPLIANCE

  • What is CFR 21 Part 11
  • How HunterLab helps a company to work in compliance
  • Predicate Rules
  • Windows System Set-up Definitions

SECTION 2: IQ/OQ/PQ PROTOCOLS

  • System overview
  • Overview of the qualification protocols
  • IQ (Installation Qualification) protocols for hardware and software
  • OQ (Operational Qualification) protocols
  • PQ (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 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.

HunterLab worldwide:

  • Headquarters, North / South America

    Hunter Associates Laboratory, Inc.

  • 11491 Sunset Hills Road

    Reston, VA 20190-5280

  • 703-471-6870

  • 703-471-4237

  • Asia-Pacific

    HunterLab Asia Limited
  • Leo Cheung, Regional Manager Flat E, 13/F Leahander Center

    28 Wang Wo Tsai Street, Tsuen Wan New Territories, Hong Kong

  • +852 2406 1723

  • Europe / Middle East / Africa

    HunterLab Europe GmbH

  • Dr.-August-Einsele-Ring 15

    82418 Murnau

  • +49 8841 9464

Ask us your question here...

Would you like to talk directly about your application/sample? Call us at
+49 8841 9464

We will show you the color measurement solution for your product.

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Our color experts will be happy to help you!

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HunterLab services

Do you want to delve deeper into spectrophotometry? Book one of our spectrophotometry courses, online or in-house. We also offer contract measurement, rental and leasing options, as well as numerous special developments. Convince yourself of our precise spectrophotometers and competent service.