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.

The Vista-ER includes the Validation and Compliance Notebook in PDF form on thumbdrive.   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.