Data Governance for Computer Systems Regulated by FDA

We will also touch on aspects of 21 CFR Part 11, the FDA’s guidance for electronic records and electronic signatures (ER/ES). There are many security aspects related to ER/ES that are key components of a sound validation and data governance program.

Objectives of the Presentation

• Discuss the best practices necessary to ensure all systems are validated appropriately
• Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk
• Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
• Learn how to develop a strategic approach to data governance to ensure data integrity, quality, identity, accessibility, and security
• Q&A

Why Should you Attend
After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information. It is a system of decision rights and accountabilities for information-related processes, executed according to agreed-upon models which describe who can take what actions with what information, and when, under what circumstances, and, finally, using what methods.

Areas Covered
In this webinar, we will cover the following key areas:

• Establishing a data governance framework and program for data that is collected, analyzed, stored or reported using a computer system subject to FDA regulations
• How to use a data governance framework as a logical structure for classifying, organizing and communicating complex activities involved in making decisions about and taking action on enterprise data
• How to ensure that data governed by FDA adheres to the principles of Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, and Electronic Records and Signatures (21 CFR Part 11), as applicable
• How to leverage industry best practices in developing an overall data governance framework and program
• How to ensure your data
• Q&A

Who will Benefit
This webinar will provide valuable assistance to all personnel in:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Personnel
• Supply Chain Personnel
• Audit Personnel
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Topic Background
Data is a company’s key asset, and must be collected and managed in a way that is compliant with FDA requirements. The systems housing data must be validated in accordance with FDA guidelines for computer system validation and must be maintained in a validated state in order to support this. A good data governance program will include aspects of computer system validation and maintenance, and also help identify the resources, processes and procedures needed to support the integrity, identity, authenticity, quality, and accessibility of your data. It is far more costly to lose sight of this and risk having data discarded or invalidated by FDA than it is to build a sound data governance program. We will also address 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).