AAMI TIR36:2007

Software used to design, develop, manufacture, or otherwise control the quality of medical devices must be validated for its intended use by 21 CFR, Part 820 (FDA’s Quality System regulation). This regulation covers a very broad scope of software, ranging from simple spreadsheets and database reports to enterprise-wide IT solutions for CAPA and complaint handling. Based on AAMI TIR36:2007 Validation of software for regulated processes, this AAMI webinar cd bridges the gap between the regulation and industry best practices. Program speakers provide a high level introduction to the content and structure of the TIR, present some of the validation philosophies that are the foundation for the methods discussed in the TIR, and discuss the practical application of the TIR to common validation challenges and compliance issues.