FDA’s Technology Modernization Action Plan and Impact on Regulated Computer Systems and Data

Overview:

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.  The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11.  This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk.  The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process.  System size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.  These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.  All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

So what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far?  The FDA is embarking on a modernization program to update their technology and processes for working with industry to assure regulated products meet FDA compliance.  There are numerous programs underway, including partnerships with other agencies and industry to move forward as technology continues to improve.  The FDA plans to take advantage of these technologies, just as industry is focused on the same goal.  The key is making sure these are employed in a way that promotes public health, providing more improved FDA-regulated products with fewer negative side effects and issues.  Plans will also enable FDA to work with industry to move products to market faster, further improving public health.

We will explore the best practices and strategic approach for evaluating the current processes involved in assuring computer systems used in the conduct FDA-regulated activities are modernized and streamlined.  Cloud computing, Software as a Service (SaaS), automated computer system testing and mobile devices are just part of the mix we can expect to explode in the near term.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

Areas covered during the Session:

• Learn how to identify “GxP” Systems
• Learn about FDA’s current program for modernization of technology, and how this will impact industry
• Learn about FDA’s Technology Modernization Action Plan (TMAP), including what work is underway and what is planned in the near term
• Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation
• We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness
• Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner.
• Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology
• Discuss the importance of “GxP” documentation that complies with FDA requirements
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

Why should you attend this training program?

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