Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.
The FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLP, GCP) related products be validated and maintained in accordance with specific rules. It’s not enough just to validate a computer system and defend your approach to regulatory agencies. Everyone from information technology analysts and clinical data scientists to compliance officers and auditors needs to ensure that the data and information collected, analyzed and reported using the system can be defended effectively.
Join this session learn all about preparing your system validation documentation for an FDA audit of your company’s computer systems. This session will help you learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner.
- 21 CFR Part 11 and what is required for compliance
- Industry best practices related to compliance and computer system validation
- Strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
- How the System Development Life Cycle (SDLC) methodology supports the computer system validation process
- How to effectively document the process of computer system validation,
- How to maintain current information about the various systems in your organization and ensure they are maintained in a validated state
- How to gain information about trends in validation, as industry progresses and new best practices emerge
- Some of the industry best practices to apply when following the SDLC methodology