Risk-Based Validation of Spreadsheet Applications

We will explore the best practices and strategic approach for evaluating Excel spreadsheets used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.

We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We will cover the approach for validating Excel spreadsheets used to conduct FDA-regulated work. Excel, as installed as a GAMP 5 Category 1 system, provides utility and must only be installed properly. However, once a user creates macros or other types of additional functionality, these turn the system into a GAMP 5 Category 5 system, which is customized. This elevates the need for validation of the spreadsheet application to ensure it has been coded correctly.

We'll walk you through the planning and validation activities required for an Excel custom application. While full validation is needed, meaning an Installation Qualification (IQ) and Operational Qualification (OQ), the work in support of validating a customized spreadsheet application can be streamlined a great deal. We'll talk about ensuring that this validation effort is based on making sure requirements are defined, tested, and proven to be met, that system suitability is taken into account in defining test scenarios and is provided by Subject Matter Experts (SMEs), and the output confirms that the system meets FDA requirements for validation, Part 11 compliance, and data integrity compliance are met.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance for a spreadsheet application. We will provide an overview of practices to best maintain the spreadsheet application in a validated state over its life, and prepare for an FDA inspection.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment, that can be leveraged to assist in all your GxP work.

Why should you Attend: Spreadsheets can be of great benefit, but there are risks that we'll talk about in this webinar. You may have many different spreadsheets used across the enterprise, many similar, while others may be vastly different. We'll walk you through assessing the spreadsheets in use and understanding how to inventory, streamline, and validate them for use with FDA-regulated activities.

Validation of a spreadsheet is much simpler and quicker to accomplish than validation of typical systems used in FDA-regulated activities, but the basics are still the same, and we'll go through these and how to apply them to an environment with spreadsheets.

Areas Covered in the Session:

• Learn how to identify spreadsheet applications that are considered to be "GxP" Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements to ensure a spreadsheet application will meet requirements and will be suitable for its intended task(s)
• Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work
• Learn about the System Development Life Cycle (SDLC) approach to validation, and how to apply this to Excel spreadsheet applications
• Discuss the best practices for documenting computer system validation efforts for spreadsheet applications, including requirements, design, development, testing and operational maintenance procedures
• Understand how to maintain a spreadsheet application in a validated state through the system's entire life cycle
• Learn how to assure the integrity of data that supports GxP work done using the spreadsheet application
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
• Know the regulatory influences that lead to FDA's current thinking at any given time
• Learn how to conduct a risk assessment on a spreadsheet application that will provide the basis for developing a validation rationale
• Learn how to best prepare for an FDA inspection or audit of a GxP spreadsheet application
• Finally, understand the industry best practices that will enable you to optimize your approach to validating spreadsheet applications, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• IT Security Staff
• QC/QA Managers and Analysts
• Production Managers and Supervisors
• Supply Chain Managers and Supervisors
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Computer System Validation Specialists
• GMP, GLP, GCP Training Specialists
• Business Stakeholders using Computer Systems regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements