1.0 INTRODUCTION

Ensuring compliance with FDA regulations is a critical responsibility for organizations that handle electronic records and E-signatures. This document serves as a comprehensive guide for individuals and entities required by statute or FDA regulations to maintain records or submit information to the FDA. Specifically, it addresses the criteria outlined in 21 CFR Part 11, which stipulates that electronic records and electronic signatures must be trustworthy, reliable, and equivalent to paper records. By following the guidance provided herein, stakeholders can ensure that their electronic systems meet these stringent standards, thereby facilitating compliance and enhancing the integrity of their data management processes.

2.0 PURPOSE

21 CFR Part 11 is the part of criteria under which the electronic records and electronic signature are considered trustworthy, reliable, and equivalent to the paper record.

3.0 SCOPE

The Scope of this 21 CFR Part 11 Requirement Assessment document is only applicable for control System for “(Software/SCADA/System Name)” Which is located in ‘‘Location Name” at “XYZ Company Name"

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1.0 GENERAL

This document provides guidance to persons who, in fulfillment of a requirement in a statute or another Part of FDA'S Regulations to maintain records or submit information to FDA.

2.0 PURPOSE

21 CFR Part 11 is the part of criteria under which the electronic records and electronic signature are considered trustworthy, reliable, and equivalent to the paper record.

3.0 SCOPE

The Scope of this 21 CFR Part 11 Requirement Assessment document is only applicable for “Enterprise Resource Planning (ERP) Software)” Which is installed at “XZY Pvt. Ltd.”.

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1.0 OBJECTIVE

The purpose of this document is to identify the risk scenarios of the System. This document also provides its mitigations. The purpose of the risk assessment is to maximize the cGMP benefits to be derived from the Control System and incorporate the regulatory requirement as per the risk criteria. The Risk Assessment process identifies the cGMP relevant risks and provides its mitigation. This document identifies the functions which may impact Patient Safety, Product Quality, and Data Integrity.

​​2.0 SCOPE

The scope of this Functional Risk Assessment Document is applicable for “Enterprise Recourses Planning Software”. Which is installed “XZY”.Risk Assessment process addresses the following points.

• Identify cGMP Risk
• Individual function risk scenario
• Identify and verify appropriate controls
• Mitigation for function risk scenario
• Review risk and monitor controls

3.0 RISK ASSESSMENT PROCESS

The Risk Assessment process for Control System is mainly based on Process Identification. This document can be used to identify the system functions

3.1 PROCESS IDENTIFICATION

3.1.1 IDENTIFY CGMP RISKS

Having determined that a particular function or sub-function may have a GxP or business risk associated with it, the assessment proceeds to identify the various risk scenarios (i.e. the events that identify the risk associated with the use of the system). It is useful to consider for each event what the likely effect will be (note that each event may have more than one effect).

The parameters for each Critical Processes and safety interlocks are identified and evaluated by risks associated with cGMP.

Risk scenarios and mitigation approaches are discussed Equipment-wise with the concerned user of Equipment from validation team members and documented whenever required.

4.0 FUNCTIONAL RISK ASSESSMENT Identify Risk to the specific processes. Identify Risk to the specific functions. Define controls to reduce the risks.

The following types of risks are mainly identified during the Risk Assessment Process.

• Related to Authorizations
• Related to Set Parameters
• Related to Process Controls and Safety interlocks
• Related to Product and personnel safety
• Related to product quality and data integrity

Based on the above Risk Assessment Report shall be prepared which describes cGMP related risks and mitigation approaches.

​​5.0 RISK ASSESSMENT METHOD

Risk management aims to establish controls such that the combination of severity, probability of occurrence, and detectability of failures is reduced to an acceptable level. Severity refers to the possible consequence of hazard.

5.1 ASSESS LIKELIHOOD

The frequency of using the occurrence of the event has been determined and has been based on identities like Low, Medium, and High. Information is collected based on the frequency of events occurring.

Probability = Likelihood of the fault occurring. Low: Frequencies are very less

Medium: Frequencies are recorded regularly.

High: Occurs frequently

5.2      ASSESS THE SEVERITY OF IMPACT

Severity = Impact on Patient Safety, Product Quality, and Data Integrity

Any events related to the following effects or requirements based on risk scenarios identifying the severity impact for Low, Medium, or High category.

Low: systems or functions have a negligible impact on data integrity, product quality, or patient safety