FDA IT and Data Modernization Efforts and Technological Innovation
Introduction
The U.S. Food and Drug Administration (FDA) has announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT). This is a significant step in the FDA’s technology and data modernization efforts, which began in 2019.
The FDA has been undertaking a modernization effort since September 2019, with the Technology Modernization Action Plan, which laid the groundwork for the more-modern approach to the use of technology for the agency’s regulatory mission. This was followed by the Data Modernization Action Plan, announced earlier this year.
FDA Technology Modernization Plan
The Technology Modernization Plan states that:
“Near-term modernization in computer hardware and software technologies are the focus of FDA’s Action Plan…Foundational requirements for a modern FDA technology infrastructure include virtual data storage (“the cloud”), problem-specific software development (“devops”), and solutions for efficiently exchanging data.”
The plan describes how modernization will encompass advanced algorithms, including artificial intelligence (e.g., machine learning), as well as modern technical strategies such as infrastructure-as-a-service, software-as-a-service, platform-as-a-service, data lakes and warehouses, distributed ledger solutions like blockchain, and Agile software development.
The plan also describes how FDA will build technology development capabilities to generate best-in-class technology solutions, incorporating a product development mindset including: development of “minimum viable products” for testing; adoption of “devops” mindset and practices; and willingness to “fail fast,” iterate and pivot.
The Plan discusses how FDA intend to advance the dialogue with stakeholders, including the technology sector, which indicates a wish to discuss, learn and adopt rather than impose unnecessary regulation.
New GAMP® Good Practice Guide
The FDA modernization philosophy stated above is strongly supported by the new GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, and IT Service Management.
This Good Practice Guide seeks to enable life-science industry innovation and advancement through the application of ISPE GAMP 5 principles and current good practice to the following topic areas:
- The application of critical thinking, including FDA CDRH Computer Software Assurance (CSA) concepts
- Incremental and iterative (Agile) software development models and methods, including DevOps
- IT service management, including cloud computing (XaaS)
The Good Practice Guide demonstrates how these areas are interwoven: applying critical thinking when leveraging software development practices and using both concepts to effectively manage IT service providers, thus encouraging a risk-based, product-quality and patient-centric approach.
