2-Day Virtual Boot Camp From Fundamentals to Advanced: Your Complete Guide to Computer System Validation (CSV) Mastery @ EARLY BIRD DISCOUNT!!
Master CSV with Hands-On Techniques: 2-Day Boot Camp for Immediate Application!

Instructor :
Carolyn Troiano
Webinar ID:
11407
Date: MAR 24 (MON) - MAR 25 (TUE), 2025
Start Time: 9 AM PT - 3 PM PT each day
Duration: 12 Hrs.

Buy This Course in a Pack of 2 courses at 25% Discount HERE:
💻 The Software Integrity Duo: Secure, Validate, and Comply
“Ensure Robust, Secure, and Compliant Software Operations Across Your Organization!”
2 Courses Included:
-
- Cyber Threats Lurking in Medical Devices: 2024-25 Compliance with IEC 62304 (duration 90 mins), find out more details here
- 2-Day Virtual Boot Camp From Fundamentals to Advanced: Your Complete Guide to Computer System Validation (CSV) Mastery (scheduled for Dec 10-11, duration 12 hrs), find out more details here
Why Pack Them Together? These courses complement each other by covering two critical aspects of software compliance: cybersecurity and validation. They provide a holistic view on ensuring medical device software meets the latest compliance requirements and is secure from threats.
Why Buy the Pack?
-
- Integrated Software Compliance Solution: Address both cybersecurity and system validation to safeguard your software from vulnerabilities while ensuring compliance.
Buy This Course in a Pack of 2 courses at 25% Discount HERE:
💻 The Software Integrity Duo: Secure, Validate, and Comply
“Ensure Robust, Secure, and Compliant Software Operations Across Your Organization!”
2 Courses Included:
-
- Cyber Threats Lurking in Medical Devices: 2024-25 Compliance with IEC 62304 (duration 90 mins), find out more details here
- 2-Day Virtual Boot Camp From Fundamentals to Advanced: Your Complete Guide to Computer System Validation (CSV) Mastery (scheduled for Dec 10-11, duration 12 hrs), find out more details here
Why Pack Them Together? These courses complement each other by covering two critical aspects of software compliance: cybersecurity and validation. They provide a holistic view on ensuring medical device software meets the latest compliance requirements and is secure from threats.
Why Buy the Pack?
-
- Integrated Software Compliance Solution: Address both cybersecurity and system validation to safeguard your software from vulnerabilities while ensuring compliance.
- Hands-On, Practical Learning: Gain real-world insights and techniques that can be applied immediately to improve system security and compliance processes.
- Bundle Savings: Receive both courses at a discounted rate, making it an excellent value for professionals responsible for software compliance.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
Buy Both Courses at a 25% discount HERE
What you will learn
-
- Understand FDA Regulations And Global Standards For Computer System Validation.
- Master CSV Techniques, SDLC Methodologies, And Risk-Based Approaches.
- Validate Cloud, SaaS, And Off-The-Shelf Software Applications.
- Ensure Data Integrity And Compliance With 21 CFR Part 11.
- Develop Effective Validation Strategies, Plans, And Key Documentation.
- Prepare For FDA Inspections With Practical Exercises And ….
-
- Understand FDA Regulations And Global Standards For Computer System Validation.
- Master CSV Techniques, SDLC Methodologies, And Risk-Based Approaches.
- Validate Cloud, SaaS, And Off-The-Shelf Software Applications.
- Ensure Data Integrity And Compliance With 21 CFR Part 11.
- Develop Effective Validation Strategies, Plans, And Key Documentation.
- Prepare For FDA Inspections With Practical Exercises And Guidance.
- Learn Best Practices For Change Management And System Retirement.
Course Description
Bootcamp Objective: As we step into 2025, the stakes in Computer System Validation (CSV) have never been higher. Unlock the skills to streamline operations, enhance efficiency, and mitigate risks in this rapidly evolving regulatory landscape.
This 12-hour intensive program provides the tools and insights you need to stay ahead in FDA-regulated industries.
Why Attend This Bootcamp?
-
- Practical Expertise: Gain actionable knowledge through real-world case studies and engaging discussions.
- Regulatory Confidence: Stay updated on key FDA regulations impacting pharmaceuticals, biotechnology, and medical devices.
- Future-Proof Strategies: Learn to plan, implement, test, and manage critical systems, ensuring compliance in a forward-looking regulatory environment.
Why This Matters in 2025
-
- Stay Compliant: With over three decades of FDA oversight on CSV, understanding data integrity remains crucial as regulatory expectations evolve.
- Master 21 CFR Part 11: Acquire expertise in managing Electronic Records and Signatures (ER/ES) and meeting advanced documentation standards.
- Adapt to Risk-Based Approaches: Build robust validation strategies aligned with the FDA’s shift toward risk-based self-assessments, addressing new system vulnerabilities effectively.
Key Learning Areas
-
- Critical Testing Factors: Master the five pivotal factors—system size, complexity, business importance, GAMP 5 category, and risk ratings.
- Data Integrity Techniques: Ensure compliance for systems that create, collect, and report data essential for operational success.
- Best Practices: Implement proven methods for assessing and validating systems in FDA-regulated environments.
In This Bootcamp, You Will:
-
- Understand the System Development Life Cycle (SDLC) with a focus on risk management and 2025 compliance trends.
- Master 21 CFR Part 11 and gain confidence in handling electronic records and signatures.
- Develop policies, procedures, and documentation to ensure smooth FDA inspections.
- Prepare for vendor audits of computer hardware, software, and services with practical insights.
- Strengthen your GxP roles with a deep understanding of industry standards and evaluation techniques.
This bootcamp is tailored for professionals in regulated industries aiming to elevate their expertise in CSV.
Whether you’re starting your CSV journey or looking to enhance your skills, this course delivers practical solutions and actionable strategies for 2025 and beyond.
Enroll Now and position yourself as a leader in CSV, ready to navigate the challenges of 2025 with confidence and mastery!
Bootcamp Objective: As we step into 2025, the stakes in Computer System Validation (CSV) have never been higher. Unlock the skills to streamline operations, enhance efficiency, and mitigate risks in this rapidly evolving regulatory landscape.
This 12-hour intensive program provides the tools and insights you need to stay ahead in FDA-regulated industries.
Why Attend This Bootcamp?
-
- Practical Expertise: Gain actionable knowledge through real-world case studies and engaging discussions.
- Regulatory Confidence: Stay updated on key FDA regulations impacting pharmaceuticals, biotechnology, and medical devices.
- Future-Proof Strategies: Learn to plan, implement, test, and manage critical systems, ensuring compliance in a forward-looking regulatory environment.
Why This Matters in 2025
-
- Stay Compliant: With over three decades of FDA oversight on CSV, understanding data integrity remains crucial as regulatory expectations evolve.
- Master 21 CFR Part 11: Acquire expertise in managing Electronic Records and Signatures (ER/ES) and meeting advanced documentation standards.
- Adapt to Risk-Based Approaches: Build robust validation strategies aligned with the FDA’s shift toward risk-based self-assessments, addressing new system vulnerabilities effectively.
Key Learning Areas
-
- Critical Testing Factors: Master the five pivotal factors—system size, complexity, business importance, GAMP 5 category, and risk ratings.
- Data Integrity Techniques: Ensure compliance for systems that create, collect, and report data essential for operational success.
- Best Practices: Implement proven methods for assessing and validating systems in FDA-regulated environments.
In This Bootcamp, You Will:
-
- Understand the System Development Life Cycle (SDLC) with a focus on risk management and 2025 compliance trends.
- Master 21 CFR Part 11 and gain confidence in handling electronic records and signatures.
- Develop policies, procedures, and documentation to ensure smooth FDA inspections.
- Prepare for vendor audits of computer hardware, software, and services with practical insights.
- Strengthen your GxP roles with a deep understanding of industry standards and evaluation techniques.
This bootcamp is tailored for professionals in regulated industries aiming to elevate their expertise in CSV.
Whether you’re starting your CSV journey or looking to enhance your skills, this course delivers practical solutions and actionable strategies for 2025 and beyond.
Enroll Now and position yourself as a leader in CSV, ready to navigate the challenges of 2025 with confidence and mastery!
Why you should attend
🔥 Don’t Wait—Save $500 with the Early Bird Discount! ⏳ Register NOW and beat the Dec 31 deadline before prices rise! 🚀💸
In today’s highly regulated environment, effective Computer System Validation (CSV) is no longer optional—it’s critical.
This 2-day intensive boot camp is designed to empower you with the latest skills, techniques, and best practices to ensure compliance, data integrity, and operational excellence.
Here’s why you can’t afford to miss it:
-
- Stay Ahead of Regulatory Changes: Align your validation practices with FDA, ICH, and Eudralex standards, including 21 CFR Part 11 and Annex 11. Be prepared for FDA inspections and ensure your systems meet the latest compliance requirements.
- Practical, Ready-to-Use Tools: Learn using standard operating procedures (SOPs) and validation templates that have been successfully implemented by other enterprises. Walk away with practical tools you can immediately apply within your organization.
- Enhance Your Validation Efficiency: Master risk-based validation techniques that streamline processes, reduce downtime, and boost efficiency. Discover how to apply the System Development Life Cycle (SDLC) approach to CSV, optimizing your validation activities.
- Overcome Real-World Challenges: Gain insights into validation strategies for various applications like Cloud/SaaS, spreadsheets, and custom systems. Learn how to address common pitfalls and ensure continuous system validation throughout its lifecycle.
- Build a Robust Validation Rationale: Understand how to conduct comprehensive risk assessments and develop a well-founded validation strategy. Focus on system size, complexity, business importance, GAMP 5 category, and potential risks to ensure inspection-readiness.
- Protect Data Integrity: Learn strategies to safeguard the integrity of GxP data across the data lifecycle. Understand the documentation requirements for maintaining validated systems, ensuring your data remains secure and compliant.
- Excel in Your GxP Role: Enhance your expertise in GxP-related roles by mastering documentation best practices, validation methods, and audit readiness. Stand out as a CSV leader within your organization, driving innovation and quality compliance.
Join our Boot Camp to Demystify CSV:
Gain the knowledge and confidence to navigate the complexities of CSV and position your organization at the forefront of compliance and quality standards. Whether you’re a beginner or looking to deepen your expertise, this course is tailored to provide actionable insights that will advance your career and skills.
Enroll Now! Don’t miss this opportunity to become a CSV expert and take your validation processes to the next level.
🔥 Don’t Wait—Save $500 with the Early Bird Discount! ⏳ Register NOW and beat the Dec 31 deadline before prices rise! 🚀💸
In today’s highly regulated environment, effective Computer System Validation (CSV) is no longer optional—it’s critical.
This 2-day intensive boot camp is designed to empower you with the latest skills, techniques, and best practices to ensure compliance, data integrity, and operational excellence.
Here’s why you can’t afford to miss it:
-
- Stay Ahead of Regulatory Changes: Align your validation practices with FDA, ICH, and Eudralex standards, including 21 CFR Part 11 and Annex 11. Be prepared for FDA inspections and ensure your systems meet the latest compliance requirements.
- Practical, Ready-to-Use Tools: Learn using standard operating procedures (SOPs) and validation templates that have been successfully implemented by other enterprises. Walk away with practical tools you can immediately apply within your organization.
- Enhance Your Validation Efficiency: Master risk-based validation techniques that streamline processes, reduce downtime, and boost efficiency. Discover how to apply the System Development Life Cycle (SDLC) approach to CSV, optimizing your validation activities.
- Overcome Real-World Challenges: Gain insights into validation strategies for various applications like Cloud/SaaS, spreadsheets, and custom systems. Learn how to address common pitfalls and ensure continuous system validation throughout its lifecycle.
- Build a Robust Validation Rationale: Understand how to conduct comprehensive risk assessments and develop a well-founded validation strategy. Focus on system size, complexity, business importance, GAMP 5 category, and potential risks to ensure inspection-readiness.
- Protect Data Integrity: Learn strategies to safeguard the integrity of GxP data across the data lifecycle. Understand the documentation requirements for maintaining validated systems, ensuring your data remains secure and compliant.
- Excel in Your GxP Role: Enhance your expertise in GxP-related roles by mastering documentation best practices, validation methods, and audit readiness. Stand out as a CSV leader within your organization, driving innovation and quality compliance.
Join our Boot Camp to Demystify CSV:
Gain the knowledge and confidence to navigate the complexities of CSV and position your organization at the forefront of compliance and quality standards. Whether you’re a beginner or looking to deepen your expertise, this course is tailored to provide actionable insights that will advance your career and skills.
Enroll Now! Don’t miss this opportunity to become a CSV expert and take your validation processes to the next level.
Course Agenda
Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?
-
- Contact us at support@compliancemeet.com to explore your options!
- We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.
DAY 1 & 2 : 6-Hrs each day
Module 1: Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
-
- FDA Compliance and Guidance
- Other Regulations and Guidance (EMA, EU, MHRA)
- Exercise: Exploring the Regulations using the fda.gov website
Module 2: CSV Methods and Models
-
- GxP Systems
- Computer System Validation (CSV)
- Validation, Verification, and Qualification
- Common SDLC Methodologies
- GAMP 5 “V” Model
Module 3: Software and Services
-
- Computer Off-the-Shelf (COTS) Software
- Cloud Systems
- FDA’s “Case for Quality”
- Software as a Service (SaaS)
- Case Study: Cloud SaaS
- Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
- Single Sign On (SSO)
- Medical Devices and Software as a Medical Device (SaaMD)
- Software Quality Assurance (SQA) Plan
- Mobile Devices and Medical Application
- Spreadsheet Validation
Module 4: 21 CFR Part 11, FDA’s Guidance for ER/ES
-
- 21 CFR Part 11 Guidance
- Electronic Records/Signatures (ER/ES) Requirements
- Exercise: FDA Guidance for ER/ES
- Vendor Audit
Module 5: Data Integrity and Governance
-
- Data Life Cycle Approach
- Data Integrity
- Data Governance
Module 6: CSV Planning
-
- Validation Strategy Document (VSD)
- Validation Strategy Components
- Rationale for Validation Testing
- GAMP 5 System Categorization
Module 7: CSV Supporting Components
-
- Good Documentation Practices (GDPs) Training
- Organizational Change Management (OCM)
- CSV Policies and Procedures
Module 8: Risk-Based CSV
-
- Risk Assessment
- Risk Mitigation
- Exercise: Validation Master Plan (VMP) Writing
Module 9: System Requirements and Design
-
- Requirements Development
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- Exercise: Interviews and URS/FRS Writing
- System Design/Configuration Management Specification (SDS/CMS)
Module 10: IQ, OQ, PQ Test Planning and Execution
-
- IQ, OQ, PQ Purpose and Contents
- CSV Test Execution
- Exercise: IQ, OQ, PQ Test Protocol Writing
- CSV Test Summary Report
Module 11: Requirements Traceability Matrix (RTM)
-
- RTM Purpose and Contents
- Exercise: RTM Writing
Module 12: Test and Validation Reports
-
- Validation Summary Report (VSR) Purpose and Contents
- System Acceptance and Release Notification
Module 13: Change Management
-
- Maintaining Validation Status
- Change Control Process
- Security and Access
- Audit Trail Review
- Incident Reporting
- Periodic System Review
- Disaster Recovery Planning
- Business Continuity Planning
Module 14: System Retirement
-
- Record Retention
- System Retirement Challenges
- Legacy Systems and Integration
- Data Migration
Module 15: FDA Warning Letters
-
- Regulatory Influences
- Regulatory Trends
- Critical Thinking
- Current Compliance and Enforcement Trends
- FDA Inspection Readiness
- Exercise: Be the Consultant
- Industry Best Practices
Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Exercises: Independent Study
The following exercises will be included in the course content and can be completed at each attendee’s discretion.
If completed before the end of the Boot Camp, the attendee may ask questions during any Q&A session. If completed after the Boot Camp, the attendee may ask questions via Compliance Meet and a response will be sent as quickly as possible.
Note that both questions and answers are provided for each exercise.
-
- Exercise: Exploring the Regulations using the fda.gov website
- Exercise: FDA Guidance for ER/ES
- Exercise: Validation Master Plan (VMP) Writing
- Exercise: Interviews and URS/FRS Writing
- Exercise: IQ, OQ, PQ Test Protocol Writing
- Exercise: RTM Writing
- Exercise: VSR Writing
- Exercise: Be the Consultant – Example of a Data Integrity Audit by FDA at a pharmaceutical manufacturer
CSV Final Exam: Completed at the discretion of the attendee. Note that both questions and answers are provided for each exercise. (100 Questions/Answers)
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?
-
- Contact us at support@compliancemeet.com to explore your options!
- We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.
DAY 1 & 2 : 6-Hrs each day
Module 1: Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
-
- FDA Compliance and Guidance
- Other Regulations and Guidance (EMA, EU, MHRA)
- Exercise: Exploring the Regulations using the fda.gov website
Module 2: CSV Methods and Models
-
- GxP Systems
- Computer System Validation (CSV)
- Validation, Verification, and Qualification
- Common SDLC Methodologies
- GAMP 5 “V” Model
Module 3: Software and Services
-
- Computer Off-the-Shelf (COTS) Software
- Cloud Systems
- FDA’s “Case for Quality”
- Software as a Service (SaaS)
- Case Study: Cloud SaaS
- Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
- Single Sign On (SSO)
- Medical Devices and Software as a Medical Device (SaaMD)
- Software Quality Assurance (SQA) Plan
- Mobile Devices and Medical Application
- Spreadsheet Validation
Module 4: 21 CFR Part 11, FDA’s Guidance for ER/ES
-
- 21 CFR Part 11 Guidance
- Electronic Records/Signatures (ER/ES) Requirements
- Exercise: FDA Guidance for ER/ES
- Vendor Audit
Module 5: Data Integrity and Governance
-
- Data Life Cycle Approach
- Data Integrity
- Data Governance
Module 6: CSV Planning
-
- Validation Strategy Document (VSD)
- Validation Strategy Components
- Rationale for Validation Testing
- GAMP 5 System Categorization
Module 7: CSV Supporting Components
-
- Good Documentation Practices (GDPs) Training
- Organizational Change Management (OCM)
- CSV Policies and Procedures
Module 8: Risk-Based CSV
-
- Risk Assessment
- Risk Mitigation
- Exercise: Validation Master Plan (VMP) Writing
Module 9: System Requirements and Design
-
- Requirements Development
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- Exercise: Interviews and URS/FRS Writing
- System Design/Configuration Management Specification (SDS/CMS)
Module 10: IQ, OQ, PQ Test Planning and Execution
-
- IQ, OQ, PQ Purpose and Contents
- CSV Test Execution
- Exercise: IQ, OQ, PQ Test Protocol Writing
- CSV Test Summary Report
Module 11: Requirements Traceability Matrix (RTM)
-
- RTM Purpose and Contents
- Exercise: RTM Writing
Module 12: Test and Validation Reports
-
- Validation Summary Report (VSR) Purpose and Contents
- System Acceptance and Release Notification
Module 13: Change Management
-
- Maintaining Validation Status
- Change Control Process
- Security and Access
- Audit Trail Review
- Incident Reporting
- Periodic System Review
- Disaster Recovery Planning
- Business Continuity Planning
Module 14: System Retirement
-
- Record Retention
- System Retirement Challenges
- Legacy Systems and Integration
- Data Migration
Module 15: FDA Warning Letters
-
- Regulatory Influences
- Regulatory Trends
- Critical Thinking
- Current Compliance and Enforcement Trends
- FDA Inspection Readiness
- Exercise: Be the Consultant
- Industry Best Practices
Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Exercises: Independent Study
The following exercises will be included in the course content and can be completed at each attendee’s discretion.
If completed before the end of the Boot Camp, the attendee may ask questions during any Q&A session. If completed after the Boot Camp, the attendee may ask questions via Compliance Meet and a response will be sent as quickly as possible.
Note that both questions and answers are provided for each exercise.
-
- Exercise: Exploring the Regulations using the fda.gov website
- Exercise: FDA Guidance for ER/ES
- Exercise: Validation Master Plan (VMP) Writing
- Exercise: Interviews and URS/FRS Writing
- Exercise: IQ, OQ, PQ Test Protocol Writing
- Exercise: RTM Writing
- Exercise: VSR Writing
- Exercise: Be the Consultant – Example of a Data Integrity Audit by FDA at a pharmaceutical manufacturer
CSV Final Exam: Completed at the discretion of the attendee. Note that both questions and answers are provided for each exercise. (100 Questions/Answers)
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
Who is this course for
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Managers Seeking To Ensure Data Integrity And Compliance
Gain the tools needed to maintain data accuracy in FDA-regulated environments. - IT Directors Aiming To Streamline Validation Processes For Critical Systems
Learn methods to reduce system downtime and optimize operational efficiency. - Regulatory Affairs Professionals Needing To Stay Updated On FDA Guidelines
Master the latest requirements, including 21 CFR Part 11, for hassle-free audits. - Training Managers Designing Development Paths For Teams In Regulated Industries
Equip your team with practical CSV knowledge to enhance compliance and productivity. - Pharmaceutical And Biotech Professionals Facing Challenges With System Validation
Learn best practices for validating complex software and systems in your industry. - Compliance Officers Looking To Strengthen Their Organization’s Validation Strategies
Develop robust validation plans that align with FDA’s risk-based approach. - HR Professionals Focused On Upskilling Staff For Regulatory Compliance
Identify key training opportunities to ensure staff are audit-ready. - Project Managers Handling Software Implementations In FDA-Regulated Settings
Gain insights into validation requirements for smooth system deployment. - Manufacturing Managers Seeking To Minimize Risks Of System Failures
Discover effective strategies for maintaining validated systems across their lifecycle.
- Quality Managers Seeking To Ensure Data Integrity And Compliance
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Managers Seeking To Ensure Data Integrity And Compliance
Gain the tools needed to maintain data accuracy in FDA-regulated environments. - IT Directors Aiming To Streamline Validation Processes For Critical Systems
Learn methods to reduce system downtime and optimize operational efficiency. - Regulatory Affairs Professionals Needing To Stay Updated On FDA Guidelines
Master the latest requirements, including 21 CFR Part 11, for hassle-free audits. - Training Managers Designing Development Paths For Teams In Regulated Industries
Equip your team with practical CSV knowledge to enhance compliance and productivity. - Pharmaceutical And Biotech Professionals Facing Challenges With System Validation
Learn best practices for validating complex software and systems in your industry. - Compliance Officers Looking To Strengthen Their Organization’s Validation Strategies
Develop robust validation plans that align with FDA’s risk-based approach. - HR Professionals Focused On Upskilling Staff For Regulatory Compliance
Identify key training opportunities to ensure staff are audit-ready. - Project Managers Handling Software Implementations In FDA-Regulated Settings
Gain insights into validation requirements for smooth system deployment. - Manufacturing Managers Seeking To Minimize Risks Of System Failures
Discover effective strategies for maintaining validated systems across their lifecycle.
- Quality Managers Seeking To Ensure Data Integrity And Compliance
Instructor Profile
Carolyn (McKillop) Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.