Benchtop Spectrophotometers
Portable Spectrophotometers
On-Line Spectrophotometers
Color Measurement Software
Validation and Compliance Solutions
Out of Production Products
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 the 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.
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.
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DQNB For Non-Regulatory Applications |
DQNB-ER (Electronic Records) For Regulatory Applications (FDA CFR 21, Part 11 |
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Protocols and process steps for Installation, Operational and Performance instrument qualification of HunterLab instrument and software:
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Protocols and process steps for setup and configuration of Windows operating systems in compliance with FDA 21 CFR Part 11 predicate rules:
– Duties of the System Administrator – Identity Verification – E-Signature Certification to FDA – Duties of System Users – Training Certificate |
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Protocols and documentation for installation of HunterLab instrument and EasyMatch QC – ER (Electronic Records) Quality Control Software
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| 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 |