Call us: +1-855-202-3299
Email: [email protected]
Speaker: Carolyn Troiano
Speaker Designation: FDA Compliance Consultant
For over 40 years, the FDA has regulated computer system validation in industries like pharmaceuticals, biotechnology, and medical devices. These requirements ensure robust planning, implementation, integration, testing, and management of systems that collect, analyze, or report regulated data.
In 1997, the FDA issued guidelines through 21 CFR Part 11, specifying requirements for validating electronic records and signatures (ER/ES) in regulated environments.
By the early 2000s, the FDA recognized it couldn’t inspect all systems and required industries to assess each system’s risk level to guide validation plans. Factors like system size, complexity, business criticality, GAMP 5 category, and risk rating determine the scope of testing needed to ensure data integrity and product safety.
The FDA’s recent focus on data integrity has increased scrutiny on systems that handle regulated data, including databases, documents, spreadsheets, and media files, which must maintain integrity throughout their lifecycle.
To modernize compliance, the FDA is updating technology and processes, collaborating with other agencies, and embracing innovations to help industry bring safe products to market more efficiently. Programs like Pharma 4.0 provide operational models that embed health regulations.
We’ll explore best practices to streamline computer system compliance, highlighting cloud computing, automated testing, and mobile technology, along with strategies for data integrity and risk assessment to support GxP activities.
The attendee will learn about Pharma 4.0 and the 4.0 Operating Model. We will discuss how Pharma 4.0 is governed by health regulations and some of the industry best practices that can help improve efficiency and effectiveness.
Pharma 4.0 can expand the connections between companies, the FDA, and other stakeholders. During the course, we will review specific business cases for using Pharma 4.0 to determine the return on investment of Pharma 4.0.
We will discuss organizational and cultural practices that are essential to Pharma 4.0 success. We will cover the Pharma 4.0 Maturity Model and how this can provide a competitive advantage to a company.
Clearly, Pharma 4.0™ is not a must, but a competitive advantage. Missing Pharma 4.0™ might be a business risk. When moving from blockbusters to niche products and personalized medicines, Pharma 4.0™ offers new ways to look at business cases.
Pharma 4.0 is an advanced technological approach that integrates digital innovation into Good Practice (GxP) processes in regulated industries like pharmaceuticals and biotechnology. It aims to modernize the development, manufacturing, and compliance of FDA-regulated products by leveraging technologies such as cloud computing, automation, and data analytics. By adopting Pharma 4.0, companies enhance data integrity, streamline regulatory compliance, and improve product safety and efficiency, all while aligning with FDA's modernization initiatives to bring products to market faster and uphold public health standards.
Carolyn Troiano has more than 40 years of experience in computer systems and data in the pharmaceutical, medical device, tobacco, cannabis, and other FDA-regulated industries, as well as in banking, insurance, and government agencies. She is currently an independent consultant, advising companies on data integrity, privacy, and compliance, including implementing large-scale, complex systems, such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Clinical Trial Master File (TMF and eTMF), Manufacturing, Quality, and Enterprise Content Management (ECM) systems.
