A Risk-Based Approach for Assessing R Package Accuracy Within a Validated Infrastructure

• Activity Number: 282 - Tools to Enable the Use of R by the Biopharmaceutical Industry in a Regulatory Setting
• Type: Topic-Contributed
• Date/Time: Wednesday, August 11, 2021 : 1:30 PM to 3:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Paulo Bargo* and Juliane Manitz and Andy Nicholls and Doug Kelkhoff and Yilong Zhang and Lyn Taylor and Joe Rickert and Marly Gotti and Keaven M Andersen
• Companies: Janssen R&D and EMD Serono and GSK and Roche and Merck & Co., Inc. and Phastar and R Consortium and Biogen and Merck & Co. Inc.
• Keywords: R validation; risk assessment; SDLC; software accuracy

Abstract

This contribution has the aim to discuss possible risk-based approaches to assess R package accuracy within a validated infrastructure. Ideas and suggestions reflect current thinking of the R Validation Hub working group, which is a cross-industry initiative funded by the R Consortium. R Validation Hub is a collaboration to support the adoption of R within a biopharmaceutical regulatory setting. In this setting, R is required to be part of a validated system, which encompasses software accuracy, reproducibility and traceability. We differentiate two types of R packages: Core and recommended packages are shipped with the basic installation. A rigorous software development lifecycle assures minimal risk. However, contributed packages may vary in their accuracy and development rigor, which could be assessed by various metrics. This cross-industry WG suggested several relevant quality metrics, and is developing an R package that provides a workflow to evaluate the quality of a set of R packages. This work may also be relevant in other regulated areas such as financial service industries and agriculture.