FDA Compliance and Clinical Trial Computer System Validation

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

1. FDA oversight of computer systems used in regulated industries
1. “GxPs” defined
2. Focus on “GCPs”
3. FDA audit and inspection objectives
4. Company compliance objectives
2. Introduction to Clinical Data Systems (CDS)
1. Defining the types of systems
2. System evaluation, scoring and selection process overview
3. Discussion of industry trends in system usage
3. Introduction to Computer System Validation (CSV)
1. FDA’s Guidance for Computerized System Validation (1983)
2. Evolution of validation
3. 21 CFR Part 11 (electronic records/electronic signatures; 1987)
4. Industries (pharmaceutical, medical device, biotechnology, tobacco, organ donation)
4. System Development Life Cycle (SDLC) framework and validation
1. SDLC phases (requirements, design, testing, implementation, acceptance, release to production, change control, retirement)
2. SDLC deliverables, timing, and documentation
3. The Requirements Traceability Matrix (RTM) – a key validation deliverable of interest to FDA
5. GAMP 5 and system classification
1. GAMP 5 system categories and criteria
2. Using GAMP 5 to develop an approach to CSV for a clinical data system
3. Evolving technology – driving a mobile application across a data lake and into the cloud
6. System risk assessment and management
1. Clinical data system inventory
2. Risk assessment, mitigation and prioritization
3. Monitoring and managing system risk throughout a clinical data system’s SDLC

Lunch Break

7. Building a solid project management plan to corral a clinical data system validation effort
1. Validation strategy and planning
2. Clinical data system implementation and validation execution
3. Validation documentation
4. System and data “owners” and “custodians”
5. Roles and responsibilities
6. Leveraging the vendor or other external resource
8. Incorporating business process re-engineering principles into the clinical data system validation effort
1. Clinical process mapping
2. Seeking opportunities for improvement
3. Building improvement into the project plan
9. Incorporating Organizational Change Management (OCM) principles into the clinical data system validation effort
1. Assessing the organization’s “appetite” for change
2. Identifying “early adopters,” “laggards,” and “resisters”
3. Effecting long-lasting change

1. Example – implementing and validating a clinical data system
1. Situation overview
2. Building a strategy
3. Managing the project using the CSV principles, SDLC methodology and good project management practices
4. SDLC phases, deliverables and templates
5. Incorporating BPR and OCM practices
6. Focus on testing as key area of FDA scrutiny
7. Wrapping up the documentation package
8. Clinical data system acceptance and release
9. Policies and procedures
10. Training – timing and best approach
11. Turnover to support
12. Ongoing validation maintenance
13. System retirement and data archival

Lunch Break

2. Ongoing monitoring and management of a clinical data system in a validated state throughout the SDLC
1. Operations and maintenance
2. System and data backup and archival
3. Change control board and best practices (high on FDA’s list for scrutiny)
4. Periodic review and assessment for revalidation
5. Policies and procedures (IT and user)
6. Ongoing training and OCM
7. Disaster Recovery (DR) planning and execution
8. Business Continuity Planning (BCP) and execution
3. System and Data Governance Board
1. Board Charter
2. Sponsorship
3. Roles and responsibilities
4. Meetings and status reporting
4. FDA’s strategy and direction – the “swinging pendulum”
1. Recent trends in FDA findings related to clinical data systems
2. Factors influencing FDA audit and inspection
3. What does the future look like?
5. Wrap-up/ Q&A

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

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.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.