Pharma Computer System Validation (Csv & Quality)

CSV and Quality Management System

What you'll learn

Overview of the Course and Career opportunities

Overview of Pharma Product Life Cycle

What is GMP and Pharma Regulations?

Quality Management System (QMS) Framework

Requirements

Fundamentals of SDLC

Description

This course provides practical end to end understanding about GxP computer system validation based on real life example. Computer system validation (CSV) is a process used in the pharmaceutical, healthcare, and other regulated industries to ensure that computerized systems are designed, developed, and operated in a manner that meets predefined requirements and regulatory guidelines. The goal of CSV is to ensure the reliability, integrity, and security of computer systems used in critical processes such as manufacturing, laboratory testing, data analysis, and documentation.Regulatory Compliance: CSV is driven by regulatory requirements imposed by organizations such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory bodies. These regulations outline specific requirements for computerized systems in terms of data integrity, security, audit trails, electronic signatures, and other relevant aspects.Validation Lifecycle: CSV follows a lifecycle approach, typically consisting of four main stages: (a) User Requirements Specification (URS), (b) Functional Requirements Specification (FRS), © Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and (d) Validation Summary Report (VSR). Each stage involves specific activities and documentation to ensure system compliance and performance.Risk Assessment: Risk assessment is a crucial component of CSV. It involves identifying and evaluating potential risks associated with the computer system, such as data integrity issues, security vulnerabilities, software errors, hardware failures, and human errors. Risk assessment helps determine the level of validation effort required and guides the selection of appropriate validation activities.Testing and Documentation: Validation activities include various testing procedures, such as unit testing, integration testing, system testing, and user acceptance testing (UAT). These tests aim to verify that the system functions as intended, meets user requirements, and operates reliably. Comprehensive documentation, including test plans, test scripts, validation protocols, and validation reports, is generated throughout the process to demonstrate compliance.Change Control: Once a computer system is validated, any changes made to the system or its associated processes need to be carefully managed. Change control procedures ensure that modifications, such as system updates, configuration changes, or software upgrades, are thoroughly evaluated, tested, and documented to maintain the validated state of the system.Audit Trail and Data Integrity: CSV emphasizes the importance of audit trails and data integrity. Audit trails are electronic records that capture and document activities performed within the system, providing a reliable chronological history of actions. Data integrity controls, such as secure access, data encryption, backup and recovery mechanisms, and prevention of data tampering, are implemented to ensure the accuracy, completeness, and consistency of data generated and stored by the system.

Overview

Section 1: Overview of GxP and Regulations

Lecture 1 01.Overview of CSV and Job Opportunities

Lecture 2 Disclaimer

Lecture 3 02.GxP Regulations

Lecture 4 03.Introduction to Good Manufacturing Practices (GMP)

Lecture 5 04.Six System Inspection Model

Section 2: Real Case Study: Implementing SAP System for Pharma with CSV Approach

Lecture 6 05.SAP Implementation Case Study

Lecture 7 06.QMS Framework for SAP Implementation

Lecture 8 07.Validation Plan Overview

Lecture 9 08.System Regulatory Impact Determination

Lecture 10 09.Signature Log and 21CFR Part 11

Lecture 11 10.Business Processes and User Requirements

Lecture 12 11.Gap List

Lecture 13 12.Functional Risk Assessment Part 1

Lecture 14 13.Functional Risk Assessment Part 2

Lecture 15 14.Functional Risk Assessment (FRA)-Part 3

Lecture 16 15.Test Strategy and Plan

Lecture 17 16.Test Cases

Lecture 18 17.Functional Specification

Lecture 19 18.Technical Specification

Lecture 20 21.Code Review

Lecture 21 19.Data Migration Strategy and Plan

Lecture 22 20.Traceability Matrix

Lecture 23 22.Stage Completion Report

Lecture 24 23.Role Authorization Matrix

Lecture 25 24.FRICEW List

Lecture 26 25.Test Close out Reports

Lecture 27 26.Cutover Plan

Lecture 28 27.Go-NoGo Document

Lecture 29 28.Data Migration Report

Lecture 30 29.Validation Report

Lecture 31 30.Hypercare Support

Lecture 32 31.BAU/Application Support

Pharma and IT professional