Considerations in Transitioning from Proprietary to Non-Proprietary Statistical Software to Support Regulatory Submissions

• Activity Number: 539 - Section on Medical Devices and Diagnostics P.M. Roundtable Discussion (Added Fee)
• Type: Roundtables
• Date/Time: Wednesday, August 2, 2017 : 12:30 PM to 1:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Theodore Lystig*
• Companies: Medtronic, Inc.
• Keywords: statistical software ; validation ; regulatory ; open source

Abstract

The continued development and maturity of open source statistical software such as R and OpenBUGS has resulted in viable alternatives to proprietary software such as SAS, SPSS, and Stata. Teams may be reticent to transition away from popular commercial packages, especially in the context of supporting regulatory submissions. Two concerns regularly raised when contemplating use of open source software involve 21 CFR Part 11 compliance, and validation (of the installation of the software in particular). Despite concerns with these issues, adoption of non-proprietary statistical software can be attractive for several reasons: lower cost, skill sets of the available labor pool (especially fresh graduates), and the ability to validate programming across multiple programs (rather than across programmers but within a single program). The objective of this roundtable session will be to share considerations and experiences (potentially ranging from hypothetical, to considered and rejected, to fully executed) in transitioning between proprietary and non-proprietary statistical software.