Computer system validation has been regulated by FDA for more than 40 years for systems used in manufacturing, testing, and distribution across FDA-regulated industries. Electronic records and signatures (ER/ES) entered the picture through 21 CFR Part 11 (1997), and FDA’s focus on data integrity has since brought spreadsheet validation to the forefront of compliance.

This webinar explores best practices for evaluating Excel spreadsheets used in FDA-regulated activities and determining the level of risk — to data integrity, process and product quality, and consumer/patient safety — should they fail. It walks through the System Development Life Cycle (SDLC) approach to validation based on risk assessment, and discusses 21 CFR Part 11 and the proper management of electronic records and signatures.

Excel installed as a GAMP 5 Category 1 system simply needs proper installation, but once a user creates macros or other functionality it becomes a customized GAMP 5 Category 5 system requiring validation. The session covers the planning and validation activities for a custom Excel application — including a streamlined Installation Qualification (IQ) and Operational Qualification (OQ) — the supporting policies and procedures, how to maintain the application in a validated state over its life, and how to prepare for an FDA inspection. It closes with industry best practices focused on data integrity and risk assessment. Attendees receive presentation materials and a certificate of completion.

After this webinar, attendees will be able to answer -

• How do you identify which spreadsheet applications are considered “GxP” systems?
• What does a risk-based Computer System Validation (CSV) approach for spreadsheets involve under FDA requirements?
• How might Computer Software Assurance (CSA) streamline spreadsheet validation work?
• How is the SDLC approach applied to validating a customized Excel application, including IQ and OQ?
• What policies, procedures, and documentation keep a spreadsheet application in a validated state?
• How do you assure data integrity and prepare for an FDA inspection of a GxP spreadsheet?

This webinar benefits the following agencies -

The session is built around U.S. FDA computer system validation expectations, 21 CFR Part 11 for electronic records and signatures, GAMP 5 (2nd Edition), and data integrity principles. It is relevant to organizations that use spreadsheets in FDA-regulated pharmaceutical, medical device, biologics, and tobacco-related work.

Who should attend?

Personnel in the following roles will benefit:

• Information Technology Analysts, Developers, and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Compliance and Audit Managers; Laboratory Managers
• Regulatory Affairs and Submissions Specialists
• Computer System Validation Specialists

Vendors and consultants involved in system implementation, validation, and compliance