Installation Qualification Protocol for NDDS Process Control System

Meta Description: This document outlines the Installation Qualification (IQ) protocol for the NDDS Process Control System, ensuring compliance with CSV and data integrity standards.

Tags: Equipment Validation, NDDS, Installation Qualification, CSV, Data Integrity

Objective

The objective of this Installation Qualification (IQ) protocol is to verify that the NDDS Process Control System (PLC/SCADA) is installed correctly and operates in accordance with the specified requirements, ensuring data integrity and compliance with applicable regulations.

Scope

This protocol applies to the NDDS Process Control System used in the production area for controlling and recording NDDS Critical Process Parameters (CPPs). It encompasses the installation, configuration, and verification of the system.

Responsibilities

• Validation Team: Responsible for executing the IQ protocol and documenting results.
• IT Department: Responsible for providing technical support during installation.
• Quality Assurance: Responsible for reviewing and approving the protocol and results.

Prerequisites

• Completion of the installation of the NDDS Process Control System.
• Availability of all necessary documentation including User Requirements Specification (URS) and System Design Specification (SDS).
• Training of personnel on the use of the NDDS Process Control System.

Equipment Description

The NDDS Process Control System integrates PLC and SCADA technologies to control and monitor microfluidics, homogenization, and TFF processes. It ensures accurate recording of NDDS CPPs and maintains data integrity through features such as audit trail, access control, and recipe management.

Test Plan

Detailed Test Cases

Test Case: IQ-01 – Verify Installation of Hardware Components

Procedure: Inspect all hardware components against the installation checklist.

Acceptance Criteria: All components installed as per specifications.

Evidence: Installation checklist signed off by the validation team.

Test Case: IQ-02 – Verify Software Installation and Configuration

Procedure: Review installation logs and confirm configuration settings against the URS.

Acceptance Criteria: Software installed without errors; configurations match URS.

Evidence: Installation logs and configuration screenshots.

Test Case: IQ-03 – Verify Access Control Settings

Procedure: Test user access levels and verify that unauthorized access is denied.

Acceptance Criteria: Access control settings restrict unauthorized access.

Evidence: Access control audit log report showing user access attempts.

Test Case: IQ-04 – Verify Audit Trail Functionality

Procedure: Perform actions within the system and verify that these actions are logged in the audit trail.

Acceptance Criteria: Audit trail logs all user actions accurately.

Evidence: Sample audit trail report demonstrating recorded actions.

Test Case: IQ-05 – Verify Recipe Management Functionality

Procedure: Create, modify, and delete recipes within the system and verify proper logging of these actions.

Acceptance Criteria: Recipes can be created, modified, and deleted as per specifications.

Evidence: Recipe management logs demonstrating actions taken.

Deviations

Any deviations from the acceptance criteria must be documented in a deviation report. Investigate the cause and implement corrective actions as necessary.

Approvals

Prepared by: [Name] – [Title] – [Date]

Reviewed by: [Name] – [Title] – [Date]

Approved by: [Name] – [Title] – [Date]