Computer System Validation (CSV) Boot Camp – Day 2 of 3 days Intensive Training

Course Description

Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems to ensure product safety and effectiveness.

IQ, OQ, PQ protocols are methods for demonstrating that equipment being used or installed will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements. Validation Summary Reports provide an overview of the entire validation project. Once the summary report is signed, the validation project is considered to be complete.

When validation projects use multiple testing systems, some organizations will produce a testing summary report for each test protocol, and then summarize the project with a final Summary Report. The amount of detail in the reports should reflect the relative complexity, business use, and regulatory risk of the system. The report is often structured to mirror the validation plan that initiated the project.

Following are the major topics covered on Day 2 of this CPE Webinar on Information Technology:

• IQ, OQ, PQ Protocols and Execution
• Test and Validation Summary Reporting
• CSV Operations & Maintenance
• CSV Support Components
• Managing FDA-Regulated Data

This CPE course is designed to completely immerse you in computer system validation (CSV). It delivers comprehensive details of the regulations impacting your systems and hands-on practice writing validation documents.

During boot camp, we will explore both a traditional waterfall approach to validation and a Computer Software Assurance (CSA) approach that is supported by FDA. CSA focuses on critical thinking and may be done according to an agile methodology, using automated testing to improve the speed and quality of the validation effort. We will highlight the key differences and what must be done to succeed with either of the two methodologies.

We will also discuss industry best practices and areas of potential confusion and risk. Both compliance with data integrity and 21 CFR Part 11, FDA’s guidance on electronic records (ER) and electronic signatures (ES) will be covered.

Boot camp is tough and challenging.

It is a three-day complete immersion in the validation process. Participants will work in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios.  The course moves quickly and participants will change gears often to keep interested high and accommodate multiple learning styles. A balance of instructor lectures, reading materials, exercises, and case studies keeps energy levels high and challenges the participants.

Learning Objectives

• To analyze the purpose and content of each validation deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Requirements Traceability Matrix, Test Summary, and Validation Report, etc.
• To discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures
• To analyze how to maintain a system in a validated state through the system’s entire life cycle
• To inspect how to assure the integrity of data that supports GxP work
• To explain the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• To analyze the key components of 21 CFR Part 11 compliance for electronic records and signatures

Recommended For

• This CPE webinar is recommended for CPA, CFE, CIA, CGFM, FPAC, CISA, CISM, CRISC, and all the titles of ISACA who are responsible for planning, execution, and support of computer system validation activities.

Who Should Attend?

Webinar Qualifies For

• 6 CPE Credit for Certified Fraud Examiner (CFE)
• 6 CPE Credit for Certified Information Systems Auditor (CISA)
• 6 CPD Credit for Certified Information Technology Professionals (CITP)
• 6 CPE Credit for Certified Internal Auditors (CIA)
• 6 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
• 6 CRE Credit for Certified Corporate FP&A Professional (FPAC)
• 6 CPD Credit for Chartered Professional Accountant (CPA Canada)
• 6 CPE Credit for Certified Management Accountants (CMA)
• 6 CPE Credit for Certified Government Financial Manager (CGFM)
• 6 CE Credit of Computer technology for Maryland Tax Preparer (MRTP) (Approval No. GEHNZ-T-00998-22-O)
• 6 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
• 6 CE Credit for Certified Wealth Strategist (CWS)
• 6 General Credit for Accountant/Bookeeper
• 6 CPE Credit for Certified in Risk and Information System Control (CRISC)

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