Computer System Validation

The course is designed to provide a thorough understanding of computer system validation. In addition, the course will address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process. The attendee will be familiar with expected content for computer validation deliverables through examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.

Computer Validation – General Overview

• Computer Validation fundamentals – a walk-through of a complete validation of a small example system
• Who needs to validate?
• What is Computer Validation?

1. Core principles
2. ­Brief history of computer validation

• Why is validation necessary and what regulations guide validation requirements?
• Review of the computer validation references in US and EU regulations and guidances:

1. ­ 21 CFR Part 211
2. ­ 21 CFR Part 820
3. ­ 21 CFR Part 11
4. ­ EU Annex 11: Computerized Systems
5. ­ Guidance: ICH Q7 GMPs for Active Pharmaceutical Ingredients
6. ­ Guidance: General Principles of Software Validation
7. ­ Guidance: Computerized Systems Used in Clinical Investigations
8. ­ Guidance: Electronic systems, records, and signatures in Clinical Investigations
9. ­ Guidance: Blood Establishment Computer System Validation in the User’s Facility

• When and how are systems validated?
• Review of key FDA Warning Letters related to computer validation

Computer Validation Process and Deliverables

• What is the SDLC (System Development Life Cycle) process?
• How does computer validation fit into the SDLC?
• What content must be covered?
• What are the expected tasks and deliverables?
• System/software specifications
• Requirements options and documentation
• How 21 CFR Part 11 applies to computer validation
• Design Qualification (DQ) and vendor selection
• Risk Assessment in computer validation

1. ­ Where does it apply?
2. ­ A walkthrough of the GAMP risk assessment process

• Validation Plans and Master Validation Plans
• Installation Qualification (IQ)

1. ­ The five topics expected in IQ documents

• Operational Qualification (OQ), Performance Qualification (PQ) / User Acceptance Testing (UAT)

1. ­ Testing strategies and level of detail
2. ­ How much testing is enough?
3. ­ Examples of effective test cases and system errors discovered

• SOPs required for system operation and maintenance

1. ­ How they related to FDA Warning Letters

• Validation Summary Reports
• General questions and answers

Overview of 21 CFR Part 11 (Part 11)

• Background and purpose of Part 11
• Overview of Part 11 (review regulation)
• Review of the Part 11 implications in regulations and guidances:

1. ­ 21 CFR Part 58   GLP
2. ­ 21 CFR Part 211 GMP
3. ­ 21 CFR Part 312 GCP (IND)
4. ­ 21 CFR Part 820 QSR
5. ­ Guidance:  Part 11 scope and application (September 2003)
6. ­ Guidance: Computerized Systems Used in Clinical Investigations
7. ­ Guide to the Inspection of Pharmaceutical Laboratories

• Review of Part 11-related FDA Warning Letters
• Discussion of example systems and the evaluation of Part 11 compliance decisions
• Industry trends and approaches – the future of Part 11 issues
• Interactive discussion of Part 11 issues and concerns (bring your questions)
• Achieving and Maintaining Part 11 Compliance

GAMP-specific Computer Validation Topics

• The industry guidance for Good Automated Manufacturing Practice (GAMP)
• How GAMP addresses the FDA’s expectations for computer validation
• GAMP validation software categories and how they add value
• A review of the supplementary GAMP guidances and where they apply

Computer System Validation and SDLC, System Development Life Cycle

• User and Functional, and Non-Functional Requirements – what the user intends the system to do
• Design, how the requirements are to meet the requirements
• The Configuration Specifications as Design elements and options for preparing them
• Development, coding standards, code review and an example of why code review is important
• Construction and implementation options

Computer System Validation and Data Integrity

• Data flow, intrinsic controls, procedural controls, and data governance
• The value of data flow diagrams
• Digitalization and how to validate digitalized processes
• Discussion on the evolution of Artificial Intelligence (AI) and how to validate
• How AI can help validation
• Validation and cybersecurity: intrusion prevention, intrusion detection, and response
• SDLC tools: from paper to workflow and testing apps
• An example of using an existing free tool to eliminate paper validation documents 

Auditing Computer Systems

• Auditing GxP computer systems
• Auditing suppliers of computer systems for GxP use
• Auditing developers for customized systems
• The general process for auditing computer systems
• Variations that can save time and money
• Review of an example audit checklist
• Primary areas of focus (what to look for)
• Examples of audit findings

Wrap-up

• Interactive Discussion / Question and Answer Period
• Additional CSV topics (TBD during course by attendees, “Parking Lot”)
• General questions and answers

"This was my first training from an outside vendor and it was a great session with the Course Director sharing lots of information. I most enjoyed the real-life examples which I could compare to my work environment."

Ritu P., Validation Engineer, CAI

“The instructor was very knowledgeable and had relevant examples to reinforce the concepts.”

Sandra G., AD, Quality Systems, bluebird bio

"One of the better training courses I have taken. The course director did a wonderful job and was very enthusiastic. The real life examples provided were helpful to tie the concepts together and demonstrate how they apply."

Jenna N., Senior Associate, PwC

"This is an excellent course for anyone wanting to learn generally accepted validation practices."

Sarah L., Document Specialist II, Mallinckrodt

"The instructor was very prepared and provided good material. I especially enjoyed the background information on audits and requirements."

Joseph, B., Manager, PwC

"The Validation of Computer Systems course was very informative and engaging. The instructor was knowledgeable and well spoken."

Laura S., Nordion

"The Course Director was excellent.  He made learning about computer systems validation a lot of fun. I loved the open discussion involved during the course."

Tushar G., Production Operator, IBM

"The Course Director managed to turn potentially dull subject into an interesting course. Good balance between basics and in-depth subjects, accompanied by examples and anecdotes from current practice."

Bas K., Senior Mfg Engineer, Brunel

"The Course Director was very knowledgeable and experienced. I would certainly recommend this course for anyone who might be interested in computer validation."

Robert R., Clinical Data Management, BSD Medical

"This course helped me understand the details of computer system validation…the ‘what, how and why.' It gave me a framework from which to start the validation process."

Deena G., Sr. Manager – Data Management Group, Sunesis Pharmaceuticals

“Not only was this course informative, but it was also enjoyable.  The small class size lead to great interactions between students and instructor.  Great bunch of people.  Course has caused me to think about issues and concerns in regard to ESU that I wouldn't have thought of otherwise.  I have a number of things to take a look at when I go back to the office.”

John J., QA Sr. Specialist, Shire

"Overall an excellent course. It's a significant accomplishment to deliver material of this nature in practical everyday terms."

Maria L., Consultant, SAS Institute

"I had no background in CSV and I had no idea how to start the documentation of our software validation process according to the FDA compliance. Now I can start when I get back to Germany! Thank you to the Course Director. He spoke slowly and clearly to help me understand him. I am German and my English is not fluent, so this was very important."

Brigitte R., Director HR/Project Manager, DoccuWare AG, Germany

"The course covered all the major parts of computer systems validation as well as the "why" of doing them. The Course Director could present to experienced and neophytes and make it interesting to all."

Sandra D., LIMS Manager, Centocor R&D

"Validation is new to me and this course gave me an overall view of what it entails. I would recommend this course to others in my company who are in the IT department or others who are directly involved with computer systems."

Linda M., Assoc. Product Safety Manager, Eisai

"Wish I had taken this course before I validated a system. The instructor was very knowledgeable."

Daniel R., Senior Validation Specialist, Glaxo (GSK)

"The Course was informative and provided a good foundation for Computer Validation. I'd recommend it to anyone new to Computer Validation."

Joe Y., Validation Consultant

"Course was superb! The Course Director was knowledgeable and his presentation was flawless. This was my first course with CfPIE and I will certainly look for additional courses relative to my specific expertise."

Henri S,. Aventis

"Good Course. Well Presented!"

Stewart S,. Optos

"Lot of information to cover but it was clearly articulated and very useful. Specific examples provided to illustrate the ideas were extremely helpful in ease of understanding."

Michael H,. Manager IT, Introgen Therapeutics

"The vendor questionnaire for FDA Software application alone paid for the course. Well done!"

Romeo P,. Johns Hopkins University

“I would like to take more courses like this one.”

Steve G., IT Manager, Johnson-Matthey

“I had no background in CSV, and I had no idea how to start the documentation of our software validation process according to the FDA compliance.  Now I can start when I get back to Germany!  Thank you to the Course Director.  He spoke slowly and clearly to help me understand him.  I am German and my English is not fluent, so this was very important.”

Brigitte R., Director HR/Project Manager, DocuWare AG, Germany

“The course covered all the major parts of computer systems validation as well as the “why” of doing them.  The Course Director could present to experienced and neophytes and make it interesting to all.”

Sandra D., LIMS Manager, J&J R&D

“Validation is new to me, and this course gave me an overall view of what it entails.  I would recommend this course to others in my company who are in the IT department or others who are directly involved with computer systems.”

Linda M., Assoc. Product Safety Manager, Eisai