Lighthouse Instruments: Validation Products

VALIDATION DOCUMENTATION (FMS-Series and VISTA™)

Lighthouse Instruments offers Valpak™, a complete set of validation protocols as well as on-site validation services designed to assist customers in their validation efforts of Lighthouse Instruments products. All Lighthouse Instruments products are designed to comply with current Good Manufacturing Practice regulations as stated in Title 21 Code of Federal Regulations, Chapter 1, Food and Drug Administration, Department of Health and Human Services.

Valpak™ is a set of nine documents that can be modified to fit a particular customer’s document format standards. Protocols have been developed that contain acceptance criteria and deviation reports. The validation process centers on the execution of nine protocols:

1. Validation Plan
2. Functional Requirements
3. 21 CFR Part 11 Assessment
4. Design Specifications
5. Requirements Trace Matrix
6. Installation Qualification
7. Operational Qualification
8. Validation Summary

Basic Documentation: Turnover Package (FMS-Series and VISTA™)

The turnover package is a basic set of documents supplied with each system. The five documents listed below allow for the basic installation, operation and maintenance of the system. NIST-traceable standards are certified and delivered with each system. A complete set of calibration and performance documentation is provided

1. Installation, Operation and Maintenance Manual
2. Calibration and Performance Certificate
3. Standards Report
4. Drawings (as-built) (VISTA Only)
a. Schematics (VISTA only)
b. Construction/Shop Drawings (VISTA only)
5. Control System Description (VISTA only)

Factory Acceptance Testing (FAT) Protocols (VISTA™ only)

In addition to the basic turnover package Lighthouse Instruments offers a complete package of Factory Acceptance Test protocols. These protocols are a basic set of tests to confirm that the system operates in a manner consistent with the Functional and Design Specifications. The four protocols are:

1. Mechanical Test Protocol
2. Electrical Test Protocol
3. Software Test Protocol
4. Functional Test Protocol

[ HOME ]