Data Governance for Computer Systems Regulated by FDA

Organizations in FDA-regulated industries, from pharmaceuticals, biologics and vaccines to tobacco, animal health and medical devices, depend on compliant computer system data management. Best practices built over three decades already help manage these systems cost-effectively; the focus now is governing the data they hold.

This 60-minute FDA data governance webinar presents governance as a quality control discipline for assessing, using, improving, monitoring, maintaining and protecting organizational information, through agreed decision rights that define who may act on which information, when, how and under what circumstances.

You'll learn what data integrity means for FDA compliance, what enforcement trends show, how to build a governance framework, and how to align governed data with CSV, SDLC methodology and 21 CFR Part 11 electronic records and signatures.

• Link data governance work and investment to corporate drivers, strategy and compliance
• Define program objectives, decision structures, roles and responsibilities
• Distinguish data owners from data stewards
• Explain the importance of data identity, trust, security, integrity, accessibility, reliability and consistency
• Design governance processes across people, processes and technology
• Put the supporting policies and procedures in place

• Defining data integrity and the criteria for FDA compliance
• FDA compliance and enforcement trends on data integrity
• Setting up a data governance framework and program for FDA-regulated computer systems
• Using the framework to classify, organize and communicate decisions about enterprise data
• Applying CSV, SDLC and 21 CFR Part 11 principles to governed data
• Drawing on industry best practices for the framework and program
• Keeping data captured, stored and maintained with integrity across its life cycle
• Q&A

Data integrity problems make up a large share of FDA audit and inspection findings, and the agency is watching closely. If you handle data that FDA may inspect, audit or review, a standardized governance program helps you protect its integrity across its life cycle and avoid negative findings.

The session suits IT, QA/QC, lab, manufacturing, warehouse, CSV, clinical, quality and regulatory staff, business stakeholders and testers, and consultants in life sciences and tobacco.

• Information Technology analysts
• Information Technology developers and testers
• QC/QA managers and analysts
• Analytical chemists
• Laboratory managers
• Automation analysts
• Manufacturing supervisors and other key personnel
• Warehouse and supply chain supervisors and other key personnel
• Computer System Validation (CSV) specialists
• GMP training specialists
• Business stakeholders/subject matter experts
• Business system/Application testers
• Clinical data managers and scientists
• Quality managers, chemists, and microbiologists
• Regulatory Affairs personnel
• Consultants in the life sciences and tobacco industries

Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of products must understand and conform to FDA requirements for data quality and integrity. Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.

Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.