VISTA-ER

Vista-ER Transmission Spectrophotometer.

Vista with Essentials-ER embedded software provides a standalone transmittance color measurement solution designed to help users achieve FDA CFR 21 Part 11 compliance. This standalone solution eliminates the need for users to purchase external ER compliant software and computer solutions.

OVERVIEW

Vista-ER Transmission Spectrophotometer.

Vista with Essentials-ER embedded software provides a standalone transmittance color measurement solution designed to help users achieve FDA CFR 21 Part 11 compliance for electronic record keeping. This standalone solution eliminates the need for users to purchase external ER compliant software and computer solutions.

The Vista-ER includes the Validation and Compliance Notebook in PDF form on thumb drive. Hard copy notebooks can be ordered separately.

VISTA-ER VALIDATION AND COMPLIANCE NOTEBOOK INCLUDES:

SECTION 1 – 21 CFR PART 11 COMPLIANCE

What is CFR 21 Part 11

How HL helps customers achieve compliance.

Predicate Rules

Setting up Windows Operating System

Definitions

SECTION 2: IQ/OQ/PQ QUALIFICATION PROTOCOLS

System overview

Qualification protocols overview

Installation Qualification Protocols for hardware and software

Operational Qualification Protocols

Performance Qualification Protocols

HunterLab onsite instrument qualification is also available.