VALIDATION DOCUMENTATION (FMS-Series and VISTA™)
LIGHTHOUSE 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 systems. All LIGHTHOUSE 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 seven 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 seven 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
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 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
Each of the LIGHTHOUSE ValPak™ documents is described in greater detail below. The documents are provided in MS Word format as drafts that end users can modify to meet their internal document format specifications:
1. Validation Plan
The purpose of the Validation Plan is to demonstrate that a LIGHTHOUSE System consistently performs in normal operations as required, designed and specified. The plan defines the actions and documents required for system validation. Approval of the plan authorizes execution of the activities defined therein. When these activities are completed, a Validation Summary Report will be issued. When that Report is approved, the LIGHTHOUSE System will be considered validated and accepted as a production system in the Corporation’s validated operating environment.
2. Functional Requirements
Necessary system functions are determined through management and end user interviews. Functional Requirements are those functions that must be satisfied for the system to be acceptable. There may be other functions that users want, but which they can do without; there may be useful functions inherent in the system that are beyond those required or wanted. The first priority of the qualification protocols is to verify those functions that are necessary for the consistent, intended, practical operation..
3. Design Specifications
Design Specifications are a response to the Functional Requirements. They define how the system will fulfill the requirements. Design specifications include system, hardware, software, and procedural specifications.
4. 21 CFR Part 11 Assessment
The purpose of the 21 CFR Part 11 Assessment is to document how the integrated system complies, electronically or procedurally, with Title 21 of the Code of Federal Regulations, Part 11, Electronic Records; Electronic Signatures.
5. Requirements Trace Matrix
The Requirements Trace Matrix is a tool to ensure that the requirements and specifications stated in the Functional Requirements, Design Specifications, and 21 CFR Part 11 Assessment documents respectively, are tested in the Installation, Operational, and Performance Qualification protocols. Each requirement is stated and traced through the design and testing phases.
6. Installation Qualification Protocol
The purpose of the Installation Qualification Protocol (IQ) is to demonstrate that a LIGHTHOUSE System is installed and ready to operate as required and specified in the Functional Requirements, 21 CFR Part 11 Assessment, and Design Specifications documents.
Installation Qualification demonstrates whether or not all of the elements of the system required for operation are present and properly integrated. The IQ establishes the first baseline for Configuration Management of the system during operational use. Configuration items include hardware, software application executables and configuration files, network connections, operator manuals, technical documents, and standard procedures for operation, calibration, preventive maintenance, and periodic re-qualification.
7. Operational Qualification Protocol
The purpose of the Operational Qualification Protocol (OQ) is to demonstrate that a properly installed LIGHTHOUSE System operates in the test environment throughout all operating ranges required and specified in the Functional Requirements, Design Specifications, and 21 CFR Part 11 Assessment. The OQ is executed after the IQ is executed and approved.
Operational Qualification tests the normal procedural path through the operation of the instrument integrated into a test environment. The test environment may be the practical operating environment or a functional image of the practical operating environment. The OQ includes start up control, system security, calibration and measurements of standards, data transfer, display verification, operator input, sequence control, error handling, record integrity, report verification, system shutdown, system failure and recovery, software and data archive, backup, and recovery.
