A strategic, risk-based approach to validating Excel spreadsheets used in FDA-regulated activities — from GAMP 5 categorization through SDLC validation, Part 11 compliance, and inspection readiness.
Includes live access & recording
Discover the strategic approach and best practices for evaluating Excel spreadsheets used in FDA-regulated activities. We'll assess the potential risks associated with spreadsheet failures on data integrity, process quality, and safety. Explore the System Development Life Cycle (SDLC) validation approach, emphasizing risk assessment, and delve into the significance of managing electronic records and signatures according to 21 CFR Part 11.
Our webinar will guide you through the validation process for Excel spreadsheets used in FDA-regulated tasks. Excel, categorized as a GAMP 5 Category 1 system during installation, must be handled with precision. However, once macros or custom functionalities are added, it becomes a GAMP 5 Category 5 system, necessitating validation to ensure accurate coding.
We'll detail the planning and validation activities required for custom Excel applications. While full validation, including Installation Qualification (IQ) and Operational Qualification (OQ), is essential, we'll streamline the process.
Learn how to define and test requirements, incorporate system suitability with input from Subject Matter Experts (SMEs), and ensure compliance with FDA validation, Part 11, and data integrity requirements.
Explore the creation of essential policies, procedures, and supporting documentation for spreadsheet compliance. Maintain your validated spreadsheet application effectively and prepare for FDA inspections with insights drawn from decades of hands-on computer system validation experience.
Gain insights into industry best practices, focusing on data integrity and risk assessment, to enhance your GxP operations.
By the end of this session, participants will be equipped to apply a practical, risk-based validation approach to GxP Excel spreadsheets.
Identify when Excel spreadsheets become GxP systems requiring validation.
Apply GAMP 5 categorization to Excel spreadsheets, from Category 1 installations to Category 5 custom applications.
Apply the System Development Life Cycle (SDLC) approach to spreadsheet design, testing, and validation.
Conduct a practical, risk-based assessment for spreadsheet validation.
Choose between CSV and CSA validation approaches for a given spreadsheet.
Define and test requirements with input from Subject Matter Experts (SMEs).
Ensure data integrity and 21 CFR Part 11 compliance in Excel-based systems.
Maintain spreadsheets in a validated state across their lifecycle and prepare for FDA inspections.
Focused areas that will strengthen how your organization validates and maintains GxP Excel spreadsheet applications.
Understand how a plain-installation Excel spreadsheet (Category 1) becomes a Category 5 system once macros or custom functionality are added.
Apply the System Development Life Cycle approach — requirements, design, testing, and maintenance — scaled to spreadsheet risk.
Manage electronic records and signatures in Excel in line with 21 CFR Part 11 and data integrity expectations.
Build the policies, procedures, and documentation needed to keep spreadsheets in a validated state and defend them under FDA inspection.
A comprehensive look at evaluating, validating, and maintaining Excel spreadsheets used in FDA-regulated activities.
Professionals across IT, quality, validation, and operations roles who build, use, or oversee GxP-regulated Excel spreadsheets.
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 FDA-Regulated Computer Systems
Regulatory Affairs Personnel
Consultants in the Life Sciences and Tobacco Industries
Interns Working at the Companies Listed Above
Excel spreadsheets are ubiquitous across FDA-regulated activities, and failures within them carry direct risk to data integrity, process quality, and safety. Under GAMP 5, a plain Excel installation is treated as a Category 1 system, but once macros or custom functionality are added, it becomes a Category 5 system that requires validation to ensure the underlying coding is accurate and reliable.
A System Development Life Cycle (SDLC) approach, applied in a risk-based and proportionate way, supports defining and testing requirements, incorporating system suitability with input from Subject Matter Experts, and ensuring compliance with FDA validation expectations, 21 CFR Part 11 electronic records and signatures requirements, and data integrity principles.
Beyond initial validation, organizations need the policies, procedures, and supporting documentation to keep spreadsheet applications in a validated state throughout their lifecycle — with clear roles and responsibilities — and to be prepared to defend that validated state during FDA inspections.
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.
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