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.
Setting up Windows Operating System
SECTION 2: IQ/OQ/PQ QUALIFICATION PROTOCOLS
Qualification protocols overview
Installation Qualification Protocols for hardware and software
Operational Qualification Protocols
Performance Qualification Protocols
HunterLab onsite instrument qualification is also available.