Certara Updates Phoenix WinNonlin Validation Suite to Streamline Computer System Validation

January 27, 2015

Phoenix® WinNonlin® Validation Suite™ 4.0 can help ensure compliance, reduce total cost of ownership and improve work efficiency

PRINCETON, NJ – Jan. 27, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced the launch of Phoenix WinNonlin Validation Suite 4.0 for automatic validation of the recently released Phoenix WinNonlin version 6.4.

Regulatory authorities expect that computer systems used in the development of drug products will be validated, to ensure that the computer system complies with the user’s requirements and functions as intended. The Phoenix WinNonlin Validation Suite provides document templates for use as starting points for validation process deliverables and nearly 200 automated test scripts for testing Phoenix WinNonlin functionality. The document templates and automated scripts in Phoenix WinNonlin Validation Suite 4.0 have been updated to reflect the new functionality in Phoenix WinNonlin 6.4.

Phoenix WinNonlin is part of the premier Phoenix PK/PD software platform used by more than 5,000 biopharmaceutical companies, veterinary and academic researchers, along with the FDA, PDMA, MHRA, EMA and other regulatory authorities to analyze and report toxicokinetic (TK)/pre-clinical and clinical PK/PD data.

“Our clients who work in a regulated environment choose to utilize the Phoenix WinNonlin Validation Suite because it allows them to streamline the validation of their Phoenix WinNonlin computer system, saving time and resources, and decreasing the total cost of ownership of the Phoenix WinNonlin software, while meeting compliance expectations,” said Certara Quality Assurance Manager Debra Fontana. “Our Validation Suite solution distills the collective knowledge and experience of Certara’s pharmacokineticists, software engineers, quality engineers, quality assurance personnel, and deployment personnel into an easy-to-use tool which facilitates the efficient execution of a Phoenix WinNonlin validation project.”

Key benefits realized when using Phoenix WinNonlin Validation Suite 4.0 include:

  • Meeting compliance expectations
  • Ensuring that Phoenix WinNonlin functions as intended in the user’s computing environment
  • Reducing the need for specialized PK/PD scientist participation in the computer system validation process
  • Minimizing the cost of computer system validation, by reducing the time required to complete computer system validation

To learn more about Phoenix WinNonlin Validation Suite 4.0, please visit: www.certara.com/products/pkpd/phx-wnl/phx-wnl-val/

About Certara
Certara is the global biosimulation technology-enabled drug development and drug safety consulting company. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit www.certara.com/Phoenix

Certara Contact:
Teresa A. Bradford, 919-852-4644
Senior Director, Marketing

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions