FDA Computer System Audit – Best Preparation Practices

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.

Session Objectives:

• 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

Areas Covered in the Session : 

• Computer system validation (CSV) and the system development life cycle (SDLC) methodology
• Good “variable” practice (GxP) (good manufacturing practice (GMP), good laboratory practice (GLP), and good clinical practice (GCP))
• Validation strategy that will take into account the system risk assessment process
• Functional requirements specification (FRS) to include the needs that are described in a specific and unique way
• System design specification (SDS) that details how the functional requirements will be delivered
• Test planning, including development of scenarios, cases and scripts (installation qualification, operational qualification and performance qualification)
• Requirements traceability matrix (RTM) that connects the requirements, design and test elements
• System acceptance and release notification
• System retirement steps to close out the life cycle
• Data archival to ensure security, integrity and compliance
• Best practices for preparing for an FDA computer system audit
• Interactive Q&A

Who Should Attend:

• Information technology analysts
• QC/QA managers
• QC/QA analysts
• Clinical data managers
• Clinical data scientists
• Analytical chemists
• Compliance managers
• Laboratory managers
• Automation analysts
• 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
• Auditors engaged in the internal inspection of labeling records and practices

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, 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. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.