❗The content presented here is sourced directly from Udemy platform. For comprehensive course details, including enrollment information, simply click on the 'Go to class' link on our website.

Updated in [September 26th, 2023]

What does this course tell?
(Please note that the following overview content is from the original platform)
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), (c) 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.

We considered the value of this course from many aspects, and finally summarized it for you from two aspects: skills and knowledge, and the people who benefit from it:
(Please note that our content is optimized through artificial intelligence tools and carefully reviewed by our editorial staff.)
What skills and knowledge will you acquire during this course?By taking this course on Pharma Computer System Validation (CSV & Quality), learners will acquire the following skills and knowledge:
1. Understanding of Regulatory Compliance: Learners will gain knowledge about the regulatory requirements imposed by organizations such as the FDA and EMA. They will learn about the specific requirements for computerized systems in terms of data integrity, security, audit trails, electronic signatures, and other relevant aspects.
2. Knowledge of Validation Lifecycle: Learners will understand the four main stages of the validation lifecycle: User Requirements Specification (URS), Functional Requirements Specification (FRS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and Validation Summary Report (VSR). They will learn about the activities and documentation required at each stage to ensure system compliance and performance.
3. Ability to Conduct Risk Assessment: Learners will acquire the skills to identify and evaluate potential risks associated with computer systems. They will learn how to assess risks such as data integrity issues, security vulnerabilities, software errors, hardware failures, and human errors. This knowledge will help them determine the level of validation effort required and guide the selection of appropriate validation activities.
4. Proficiency in Testing and Documentation: Learners will gain practical experience in various testing procedures, including unit testing, integration testing, system testing, and user acceptance testing (UAT). They will learn how to verify that the system functions as intended, meets user requirements, and operates reliably. Additionally, learners will develop skills in generating comprehensive documentation, such as test plans, test scripts, validation protocols, and validation reports, to demonstrate compliance.
5. Understanding of Change Control: Learners will learn about change control procedures and how to manage modifications made to validated computer systems. They will gain knowledge on evaluating, testing, and documenting changes such as system updates, configuration changes, or software upgrades to maintain the validated state of the system.
6. Knowledge of Audit Trail and Data Integrity: Learners will understand the importance of audit trails and data integrity in CSV. They will learn how to implement and maintain audit trails, which capture and document activities performed within the system. Additionally, learners will gain knowledge on implementing data integrity controls, such as secure access, data encryption, backup and recovery mechanisms, and prevention of data tampering, to ensure the accuracy, completeness, and consistency of data generated and stored by the system.

Who will benefit from this course?
Professionals working in the pharmaceutical, healthcare, and other regulated industries will benefit from this course on Pharma Computer System Validation (CSV & Quality). Specifically, individuals involved in the design, development, operation, and maintenance of computerized systems used in critical processes such as manufacturing, laboratory testing, data analysis, and documentation will find this course valuable.

Regulatory Compliance: Professionals responsible for ensuring regulatory compliance, such as quality assurance managers, regulatory affairs specialists, and compliance officers, will benefit from this course. It provides a comprehensive understanding of the regulatory requirements imposed by organizations like the FDA and EMA, including data integrity, security, audit trails, electronic signatures, and other relevant aspects.

Validation Lifecycle: Professionals involved in the validation process, such as validation engineers, validation specialists, and quality control analysts, will find this course beneficial. It covers the four main stages of CSV - User Requirements Specification, Functional Requirements Specification, Installation Qualification, Operational Qualification, Performance Qualification, and Validation Summary Report. This knowledge will help them effectively plan, execute, and document validation activities.

Risk Assessment: Professionals responsible for risk assessment and management, such as risk managers and quality risk analysts, will gain valuable insights from this course. It explains the importance of identifying and evaluating potential risks associated with computer systems, enabling them to determine the level of validation effort required and select appropriate validation activities.

Testing and Documentation: Professionals involved in testing and documentation, such as software testers, validation analysts, and technical writers, will benefit from this course. It covers various testing procedures, including unit testing, integration testing, system testing, and user acceptance testing, ensuring that they understand how to verify system functionality, meet user requirements, and generate comprehensive validation documentation.

Change Control: Professionals responsible for change control, such as change control managers and change control coordinators, will find this course valuable. It provides guidance on managing modifications to computer systems and associated processes, ensuring that changes are thoroughly evaluated, tested, and documented to maintain system validation.

Audit Trail and Data Integrity: Professionals involved in ensuring data integrity and managing audit trails, such as data integrity officers and IT security specialists, will benefit from this course. It emphasizes the importance of implementing data integrity controls and maintaining reliable audit trails, enabling them to ensure the accuracy, completeness, and consistency of data generated and stored by computer systems.

Course Syllabus

Overview of GxP and Regulations

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