Read More
question

Have A Question?

Digital Qualification (IQOQPQ) Software

The HunterLab Digital Qualification Notebook (DQNB) is an industry 4.0 digital workflow enabled software solution designed to facilitate simplified user creation of a comprehensive Validation and Compliance “Qualification Notebook” for HunterLab instruments. Generating easy to follow step-by-step instructions, DQNB provides instrument and application specific IQ, OQ, and PQ protocols and documentation that are used to validate proper instrument installation and performance for the intended application.

Digital Qualification (IQOQPQ) Software Get A Quote

As Simple as 1, 2, 3

The DQNB software incorporates a simple user interface that allows a user to input their company information, select their sample type(s), and select any accessories that they purchased with the instrument that will be used for color measurement of their samples. In a few easy clicks, the DQNB Document Generator uses these inputs to generate the appropriate Validation and Compliance notebook, which can be printed out, placed in a binder, and used to document the IQ, OQ and PQ processes.

HunterLab Validation and Compliances Solutions

HunterLab offers several solutions for Validation and Compliance of HunterLab instruments and software, including DQNB, and customized professional onsite validation services.

DQNB

For Non-Regulatory Applications

DQNB-ER (Electronic Records)

For Regulatory Applications (FDA CFR 21, Part 11

Protocols and process steps for Installation, Operational and Performance instrument qualification of HunterLab instrument and software:

 

  • Customer and instrument information
  • IQ/OQ/PQ Protocols Overview
  • System Overview
  • IQ Protocols
  • OQ Protocols
  • PQ Protocols
  • Exceptional Conditions Reports
  • Reference Documents List

Protocols and process steps for setup and configuration of Windows operating systems in compliance with FDA 21 CFR Part 11 predicate rules:

 

  • About Microsoft Windows Security Features
  • Setting Up Your Windows System
  • Signatures and Audit Trail
  • 21 CFR 11 Compliance Table
  • System Validation Checklist
  • Establishing Standard Operating Procedures (SOPs)
  • CFR Documents:

-          Duties of the System Administrator

-          Identity Verification

-          E-Signature Certification to FDA

-          Duties of System Users

-          Training Certificate

Protocols and documentation for installation of HunterLab instrument and EasyMatch QC – ER (Electronic Records) Quality Control Software

  • Customer and instrument information
  • IQ/OQ/PQ Protocols Overview
  • System Overview
  • IQ Protocols
  • OQ Protocols
  • PQ Protocols
  • Exceptional Conditions Reports
  • Reference Documents List

 

SW License good for the life of the instrument

SW license good for the life of the instrument

Onsite commissioning and re-qualification available

Onsite commissioning and re-qualification available


Learn more about IQ/OQ/PQ for Color Measurement Instrumentation