Phoenix WinNonlin Validation Suite: Decrease the Time and Cost of Your Validation

On-Demand Webinar

Do you or your company spend weeks or months manually performing the necessary steps for software validation?

In this webinar, the Certara team discussed the requirements for computer system validation, how it’s performed, and how Certara’s validation products can significantly reduce the time, resources, and cost of the on-site validation of your Phoenix WinNonlin computer system.

Debra Fontana, Quality Assurance Manager, and Linda Hughes, Principal Software Engineer, also presented the Phoenix WinNonlin Validation Suite, which includes nearly 200 automated test scripts to minimize test case preparation and execution time, and five validation document templates to speed document preparation. The updates included in Phoenix WinNonlin Validation Suite 4.0, for use in testing Phoenix WinNonlin 6.4 (part of the Phoenix 1.4 platform), were discussed.

About Our Speakers

Debra Fontana, Director, Quality Assurance, Certara. Debra Fontana is the Director of Quality Assurance here at Certara. Prior to joining Certara, Debra was the owner and Principal Consultant of Integrated Compliance Solutions, a computer system validation consultancy. In over 24 years in the life sciences industry, Debra has also held computer system validation, QA, QC, and parenteral production technical support positions at Serentec, Inc., AAI, and Eli Lilly and Company. Debra graduated from Butler University in Indianapolis, IN with a B.S. in Pharmacy (Cum Laude), and is a Registered Pharmacist in the State of Indiana.

Linda Hughes, Principal Software Engineer, Certara. Linda Hughes is a Principal Software Engineer with Certara. She has worked in software development for the pharmaceutical industry for over 15 years. At Certara, she has worked on development of the tools for Bioequivalence, Linear Mixed Effects Modeling, Noncompartmental Analysis, IVIVC, Convolution, and Deconvolution. She holds an M.S. degree in Electrical Engineering and B.A. degree in Mathematics, both from the University of Maryland.

Do you or your company spend weeks or months manually performing the necessary steps for software validation?

In this webinar, the Certara team discussed the requirements for computer system validation, how it’s performed, and how Certara’s validation products can significantly reduce the time, resources, and cost of the on-site validation of your Phoenix WinNonlin computer system.

Debra Fontana, Quality Assurance Manager, and Linda Hughes, Principal Software Engineer, also presented the Phoenix WinNonlin Validation Suite, which includes nearly 200 automated test scripts to minimize test case preparation and execution time, and five validation document templates to speed document preparation. The updates included in Phoenix WinNonlin Validation Suite 4.0, for use in testing Phoenix WinNonlin 6.4 (part of the Phoenix 1.4 platform), were discussed.