FDA’s Technology Modernization Action Plan (TMAP) And Impact On Regulated Computer Systems And Data
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco, e-cigarette/e-liquid, and other FDA-regulated industries. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe, developing validation programs and strategies, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
This webinar will focus on the efforts by the FDA to modernize their own technology infrastructure, and what this means to the industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by the FDA for this purpose and discuss specific actions that are planned and in progress. We will also discuss FDA’s more recent push to Software Quality Assurance (SQA) and away from traditional Computer System Validation (CSV), which is based on the System Development Life Cycle (SDLC) methodology. FDA is stressing the importance of industry understanding what is required to be in compliance and thinking critically about new ways to achieve that. We will cover automated testing and continuous validation as key components of the SQA approach.
- Learn how to identify “GxP” Systems
- Learn about FDA’s current program for modernization of technology, and how this will impact the 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 the 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 the 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
Course Level - Intermediate
Who Should Attend
- 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 ManagersClinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors responsible for software development, testing, and maintenance
- Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
Why Should You Attend
The attendee will learn about the FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products. We will also discuss the important aspects of CSV and how to apply them in a new and modern technological environment.
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 the 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 the 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” products, meaning they are used to create, collect, analyze, manage, transfer, and report data regulated by the 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 the 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 the 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 of 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.