PROJECT APPROACH, QUALIFICATION AND TRAINING
Lighthouse Monitoring systems are developed, installed, tested and qualified in accordance with the GAMP-5 guidelines (V-model) to ensure that the high set requirements are met for the right operations and quality control.
The agreed project steps can be recorded in a Quality and Project Plan (QPP).
This document contains, in addition to all hardware and software that has to be provided, details about planning, project-team, obligations, and documentation which is required or mandatory.
A qualification and documentation manual can contain the following chapters:
Chapter 1: Document Guide
Chapter 2: User Requirement Specification (drawn up in cooperation)
Chapter 3: Quality and Project Plan
Chapter 4: Functional Specification
Chapter 5: Risk based analysis report
Chapter 6: System Design Specification
Chapter 7: Factory Acceptance Test
Chapter 8: Site Acceptance Test
Chapter 9: Installation Qualification Protocol
Chapter 10 Operational Qualification Protocol
Chapter 11: Performance Qualification
Chapter 12: Project Review Report
Chapter 13: Change Control Documents
Chapter 14: Training Certificates
Chapter 15: User manuals
Chapter 16: Maintenance manual
Chapter 17: Calibration reports
Chapter 18: Service Level Agreement
After delivery of each monitoring system, both the administrators and users will be trained to maintain and use the system optimally. Training can always be repeated on request. Where necessary, the administrator can get support from Lighthouse through a SLA contract. Training can take place both on-site and at Lighthouse.