Data Integrity and Governance for Computer Systems Regulated by FDA

Overview:

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.  This includes development of a company philosophy and approach, and incorporating it into an overall computer system validation program and plans for individual systems that are regulated by FDA.  It also requires a recognition that Data Integrity issues continue to be a strong area of focus by FDA during inspection, and there are many examples and best practices that will be covered in this seminar to address them.

FDA’s guidelines for computerized systems were enacted in 1983, and very little has changed, other than technology, since that time, as it relates to validation.  The premise for compliance is demonstrating clearly and completely that a computer system does what it purports to do.  This means developing a very detailed set of unique and testable functional requirements, and creating a set of test scripts that will prove each requirement is met.

This webinar will describe the approach to determining the level and robustness of testing required, based on a thorough risk assessment of the system, which includes the likelihood, severity, and detectability of potential failures of the system to work as expected, and the mitigation to be applied, should the system fail.  Along with system categorization, in accordance with GAMP 5 principles, and an evaluation of the complexity and application of the software, the attendee will understand how to develop the rationale they will include in the validation plan for the level of testing executed.

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for validation, which will be discussed.   We will also delve into the training requirements for users, testers, and those who will be the stewards of the system.  All must be carefully documented.  The overall approach will be to develop a data governance framework to meet requirements for data integrity.

Disaster Recovery and Business Continuity Planning will also be touched upon as key aspects of supporting the system in a validated state.  Change control and periodic review will address the challenges of making certain that the system remains in control and is tested further according to any needs that arise from changes.

As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt.  New technologies will continue to emerge that will change the way companies do business.  While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

Areas covered during the session:

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Data Integrity (DI)
• Data Governance (DG)
• Validation Strategy, Planning and Execution
• System Risk Assessment
• GAMP 5 “V” Model and Software Categorization
• 21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
• 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 CSV and DI assurance
• Training and Organizational Change Management
• Current FDA Trends in Compliance and Enforcement
• Industry Best Practices and Common Pitfalls
• Q&A

Why Should you attend?

This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation (CSV), which is in accordance with the System Development Life Cycle (SDLC) Methodology.   This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.  It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

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.

In addition, FDA has heavily focused its resources on inspection targeting Data Integrity (DI).  During the past ten years, the percentage of Form 483 citations and Warning Letters with issues related to DI has increased dramatically, and continues to do so through 2019.  We will provide the requirements related to DI, examples of FDA findings, and will cover the industry best practices that will help you mitigate this potential risk.

What industries will benefit from your training?

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who Should Attend?

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection of labeling records and practices