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Carolyn Troiano
The FDA has regulated computer system validation for over three decades, crucial in pharmaceuticals, biotechnology, medical devices, and other FDA-regulated sectors. Compliance ensures meticulous planning, integration, and management of systems handling data critical to product manufacturing, testing, and distribution.
Electronic Records and Signatures (ER/ES) gained prominence with the FDA's 1997 guidelines, articulated in 21 CFR Part 11, outlining requirements for validating and documenting ER/ES capability in regulated systems.
In the early 2000s, recognizing the impracticality of inspecting every system, the FDA shifted focus to risk-based assessments. Factors such as system size, complexity, and business criticality determine the validation approach, emphasizing data integrity and product safety.
Recent FDA inspections underscore the significance of data integrity, extending to all systems influencing product integrity and consumer safety. Managing structured and unstructured data throughout its lifecycle is imperative.
Our webinar delves into best practices for evaluating FDA-regulated systems, emphasizing risk assessment's pivotal role in ensuring data integrity, process quality, and consumer safety. We navigate the System Development Life Cycle (SDLC) approach to validation, including insights into 21 CFR Part 11 compliance.
We address validating infrastructure components, including cloud-based and Software-as-a-Service (SaaS) solutions, necessitating distinct approaches for Installation Qualification (IQ) audits.
Furthermore, we outline essential policies and procedures, support documentation vital for compliance, and prepare attendees for FDA inspections. We stress the importance of auditing system vendors and utilities to maintain compliance.
Lastly, we offer insights into industry best practices, emphasizing data integrity and risk assessment to enhance GxP compliance across regulated industries.
This webinar is beneficial for:
Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
