1.0 PURPOSE

This document is to identify the risk scenarios and to define their priorities and measures for Computerized Systems and Software. The objective is to identify potential areas of the automation that may fail to perform to expectation, and to identify those risk points that affect quality of product and data integrity.

The purpose of the risk assessment is to maximize the benefits of safe operations of the system and minimize potential risks to product quality and/or patient safety.

2.0  SCOPE

The scope of this document is for the Risk Assessment of installed Computerized Systems and software and will be used for the further life cycle of the project.

The scope covers following types of Computerized Systems.

• Computerized Laboratory Systems with Application Software
• SCADA Based Process Control System

For the scope of this document, risk is defined as the combination of the probability of occurrence of adverse event or harm and the severity of that event. The approach followed is of GAMP 5 guidelines

3.0 RISK ASSESSMENT PROCESS

The GAMP 5 based Quality Risk Assessment process addresses the following five steps

Diagram Here

The emphasis is on constantly narrowing the focus to the point where rigorous testing and additional controls are only applied where the risk warrants.

3.1 Initial Risk Assessment

This is the first step of the process and runs in parallel with development of User Requirement Specification.

Risks introduced by computerization of the business process are included in this assessment e.g. electronic record integrity. The process owner and quality unit are involved at this stage. The assessment includes a decision whether the system is GxP regulated or not and includes an overall assessment of the system impact.

The Computerized Systems use different types of software as listed below

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1.0 INTRODUCTION

This document is prepared based on the GxP assessment of Control system for “Rapid Mixer Granulator (RMG)” IRA is a collection of GxP assessment, Software hardware categorization and system impact assessment.

2.0 PURPOSE

The purpose of this IRA document is to identify and the document that the Control system for “Rapid Mixer Granulator (RMG)” is determinate the IRA criteria.

3.0 OBJECTIVE

The objective of this document is to identify the initial risk assessment of Control system for “Rapid Mixer Granulator (RMG)”. The assessment should be based on understanding of business processes and business risk assessments, user requirements, regulatory requirements, and known functional areas.

The intent of this document is to perform a system GxP impact assessment and applicability of electronic records and signatures based on an understanding of business processes, user requirements, regulatory requirements and known functional areas. An overall assessment of system impact on GxP processes and other regulatory agencies requirements will be carried out. The results of this initial risk assessment will include a decision on whether the system is GxP regulated or not.

4.0 SCOPE

The Scope of this IRA is only applicable for control System for “Rapid Mixer Granulator (RMG)” Which is located in “Location Name” at “Company Name”.

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