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It is true that Certara validated the Phoenix WinNonlin software before we released it to customers.
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I don’t have to validate Phoenix WinNonlin because you (ie, Certara, the Phoenix WinNonlin vendor), already validated the software before you released it.
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In addition to the misconception mentioned above regarding Part 11 being the driver for computer system validation, here are some other misconceptions that I often hear customers mention: What are some common misconceptions regarding CSV? In 2010, the European Union issued Annex 11, which stipulates the rules governing good manufacturing practice for using computer systems to develop medicinal products. The earliest regulations for CSV date back to the 1960s with the United States cGMP regulations 21 CFR Parts 210-211, which state that “computers…shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance.” The US FDA set forth additional requirements in the late 1990s with the Computerized Systems Used in Clinical Trials Guidance for Industry, which requires that “sponsors who use computerized systems in clinical trials to document that these systems conform to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance”. Yet, the requirement for CSV has been around for much longer than Part 11. Many people think that 1997’s 21 CFR Part 11 Electronic Records Electronic Signatures regulation is the driver for computer system validation. There are a number of regulations and guidelines that detail the requirements for CSV. CSV occurs in the user’s environment and accounts for the user’s specific requirements. It applies to the “implemented computer system,” not just the software. What is computer system validation and what regulations/guidelines require it?Ĭomputer system validation (CSV) is documented evidence that a computer system does what it is intended to do. In this blog post, I will discuss what computer system validation is and what regulations/guidelines require it, clarify some common misconceptions, and provide information about how Certara can make your Phoenix WinNonlin validation easier. As a recent article points out, failure to do computer system validation for the software functionality that a user intends to use, with data sets that mimic the data sets that the user expects to use, can lead to a user failing to discover that a computer system provides erroneous results.Ĭlearly, computer system validation is an important activity, one that is often met with dread, frequently caused by misconceptions about this topic. To satisfy regulatory expectations, these computer systems should be validated. Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and pharmacodynamics (PD) of an investigational drug.