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
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.