HPLC System Software Validation Plan

Introduction

Softwares are used to operate and interpret the analysis results in HPLC systems. There are many softwares those are used in different HPLC systems. All softwares are required to validate to ensure the accuracy of the produced data.

Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therein to support the qualification and operation of Computer System, which are connected with the HPLC systems.

Purpose

This validation plan is to outline the activities carried out for software validation of HPLC system as per the approach described in the validation plan.

Scope

This software validation is limited to HPLC system its unique components and control system that defines the hardware and software.

Policy Compliance

This document is being written to comply with regulatory requirements for software validation of HPLC systems.

Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity. Computer system validation also reduces long-term system and project costs by minimizing the cost of maintenance and rework.

Approach

This validation is conducted as a retrospective validation. The validation plan documents the process that is to demonstrate the equipment performs as intended.

Based on the user requirement, design, test plan and test scripts are developed and verified against the existing system and software validation package carried out at the site by the supplier.

Roles & Responsibilities

Specific responsibilities related to the software validation of the HPLC systems outlined in the Validation Plan. In general, the activities associated with this project, are the responsibility of the individuals and groups listed in the Validation Plan.

Regulatory Status

This system is GxP system. System components that purchased are identified in the Qualification carried out by the supplier in the presence of system custodian.

Deliverables

The following is the list of deliverable developed to comply with the policy standards.

User Requirements

The user requirements developed. User requirements defined for the existing system based on the critical functions performed by the system.

Vendor Management

The IQ/OQ/PQ has been outsourced to the manufacturer. The documents are verified and found satisfactory. Qualification of HPLC systems for hardware and software at the site is carried out in the presence of system custodian. The detailed training of hardware and software provided to users. Troubleshooting and maintenance services are provided by the supplier as and when required. The manufacturer is a primary supplier of the HPLC system and provides technical support and services as well as technical assistance. The manufacturer had provided us a certificate of compliance.

Design

A design document developed with the help of the available reference manuals, literature. We have collected the information from the documentation provided by the manufacturer of the respective system, but we have also used the current implementation of the system to understand how the system was built.

Application Software

This system is custom off the shelf, no macro has been developed. Therefore no source code review is performed. The manufacturer has a coding standard, which is unique, traceable and secure. It also has good development practices for application software manufacturing.

Testing

We have developed a test plan consisting test protocol with the help of the current operating procedure documents and testing performed accordingly.

Security Plan

HPLC instrument located in Quality Control Instrument room having an adequate facility (e.g. proper air-conditioned and UPS power supply) at QC Department, SPI, Dadra. QC Department is having a duplicate lock & key facility. One key is kept with the Security Department and another with QC In-charge. Only In-charge is authorized to open the QC room. Operating of HPLC systems are allowed only to authorized personnel.

Backup and restore

We have developed a Backup and restore procedure with the help of the current backup system.

Training

The existing people have been trained for use of Chromatographic Systems and new joinee shall be trained for the operation of HPLC systems. Training record shall manage as per the training guideline of Quality Control.

Change Control

Change control procedure is followed as per SOP.

Periodic Review

The periodic review of documentation and status of validation shall be conducted. The evidence of the review shall be documented separately.

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