During this webinar, we will focus on the importance of ensuring that both structured (e.g., database records) and unstructured (e.g., Word document, PDF, spreadsheet) data are maintained with integrity through their chronological life cycle. This requires recognition that FDA is laser-focused on data integrity issues based on industry inspection trends during the past decade.
FDA’s Guidance for Data Integrity, issued in December 2018, did not include a single new requirement. Instead, it reiterated parts of the Code of Federal Regulations (CFRs) that have been in place for decades, and which industry was failing to meet.
From FDA’s perspective, the remedy is for management to foster a culture of accountability, and for the quality function to perform their oversight role more consistently and effectively. There are many examples and best practices that will be covered in this webinar to address these areas of concern.
One key is having a strong computer system validation program, including a very detailed set of unique and testable/verifiable requirements, and creating a set of test scripts that will prove each requirement is met.
In this webinar, we will describe the approach to determining the level and robustness of testing required, based on a thorough risk assessment of the system. The attendee will learn how to develop a rationale for testing in the validation plan.
As a part of computer system testing during validation, it is critical to consider the “ALCOA+” principles of data integrity: Attributable, Legible, Contemporaneous, Original or “True” Copy, Accurate, Complete, Consistent, Enduring and Available. Each of these must be treated as a requirement and must be tested or verified to ensure FDA’s expectations are met.
The rules for data integrity are somewhat similar to those of FDA’s 21 CFR Part 11 Guidance for Using Electronic Records (ER) and Electronic Signatures (ES) issued in 1997. Many of the technical and procedural controls that can mitigate potential risk are similar. In this webinar, we will discuss a simple approach to validation testing to ensure both data integrity and ER/ES requirements are met.
A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for validation. Along with training and documentation, this will set the foundation for developing an appropriate data governance program. We will discuss the key components of data governance and how to build this capability in your organization.
Areas Covered in the Session:
- Computer System Validation (CSV)
- Computer Software Assurance (CSA; Draft Issued September 2022)
- System Development Life Cycle (SDLC) Methodology
- GxP, where “x” is a variable (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- Data Integrity
- Data Governance
- 21 CFR Part 11 Guidance for Using ER/ES
- Validation Strategy, Planning and Execution
- GAMP5, Second Edition (July 2022)
- GAMP5 “V” Model and Software Categorization
- Risk Assessment and Mitigation
- Security, Access, Change Control and Audit Trail
- Criteria required to ensure data is created and maintained with integrity through its life cycle
- Policies and Procedures to support validation and both data integrity and ER/ES assurance
- Current FDA Trends in Compliance and Enforcement
- Industry Best Practices and Common Pitfalls
- Q&A
Why You Should Attend:
This webinar will help you understand FDA’s guidelines for validation of computer systems, and develop an appropriate validation strategy. This includes ensuring a system is maintained in a validated state through its entire life.
The SDLC will provide a framework for validation planning, allowing the attendee to understand all of the phases and deliverables required during validation. The end result will be a very well documented validation effort that will stand up to FDA scrutiny during an audit, and assure that the data housed and/or processed using the validated computer system will be maintained with great integrity.
It is important to remember that in addition to validating a computer system subject to FDA compliance, the system must be maintained in a validated state throughout its lifecycle, until the system is retired or otherwise no longer used. This webinar will describe the policies, procedures, training and other underlying support elements that are needed to ensure ongoing maintenance of a system in a validated state.
With FDA resources heavily focused on inspection targeting both data integrity and ER/ES, this webinar will provide insight into meeting compliance, following a streamlined, cost-effective approach. We will discuss FDA’s requirements and provide examples of FDA citations. You will also learn about current industry best practices that will help you mitigate potential risk.
Target Audience:
Industries:
- Pharmaceutical
- Medical Device
- Biologicals
- Tobacco (based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor/E-Cigarettes/Cigars (based on the “Deeming” Act of 2016)
- Medical Device software development and support
- Software as a Medical Device (SaMD) software developers
- Third-Party companies that support those in the above industries
Roles:
This webinar is intended for those involved in computer system validation planning and execution, and the use and ongoing support of FDA-regulated systems. Examples include:
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Key Words:
- Validation Strategy, Planning and Execution
- Installation Qualification (IQ)
- User Acceptance Testing (UAT)
- Computer Software Assurance (CSA)
- System Development Life Cycle (SDLC)
- Agile Software Development Methodology
- Waterfall Software Development Methodology
- Commercial Off-the-Shelf Software (COTS)
- Cloud Computing
- Software-as-a-Service (SaaS)
- Automated Testing
- GxP Systems
- GMP/GLP/GCP
- Technical and Procedural Controls
- Risk Assessment
- GAMP®5, 2nd Edition
- Quality Assurance
- Data Integrity
- Data Governance
- FDA Warning Letter
- FDA Consent Decree
- FDA Regulations