Background

R-IQ-OQ is an R/RMarkdown based program designed to serve as a foundation for the Installation Qualification (IQ) and Operational Qualification (OQ) of R (http://www.r-project.org/) when used in environments (such as regulated clinical trials) where such processes may be required.

In these environments, documentation is typically required to demonstrate that software applications have been installed correctly using vendor defined procedures and that the application is operating correctly, using a pre-defined set of tests.

The R-validation.Rmd file will generate an automated report that provides output that can be part of user defined and created standard operating procedures (SOPs) in which such IQ and OQ tests are performed. These post-installation tests are defined by the R Foundation in the R Installation and Administration Manual available at:

http://cran.r-project.org/doc/manuals/R-admin.html

For regulated clinical trials, the R Foundation also provides a document entitled:

R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments

available from:

http://www.r-project.org/doc/R-FDA.pdf

which provides guidance on the use of R in such environments, including references to relevant FDA regulatory guidance documents, descriptions of R’s Software Development Life Cycle (SDLC) and information regarding the applicability of various aspects of Title 21 of the U.S. Code of Federal Regulations Part 11 (21 CFR 11) and how R fits within that framework.

Note that there is also a more general description of R’s Software Development Life Cycle (SDLC), which is available from:

http://www.r-project.org/doc/R-SDLC.pdf

and contains a subset of the relevant content from the R-FDA document, excluding the content that is specifically targeted to clinical trials.

It is important to note that the output of the R-IQ-OQ program is designed to serve as a general purpose template for use by those operating in environments where installation and operational qualification of software applications is deemed to be needed. The structure and content of the resultant report may not satisfy all needs and you are free to modify the report as your local requirements and SOPs may necessitate.

Please note that all programs are made available under the GNU GPL version 2 license, so please observe the copyright and distribution requirements of that license. See the LICENSE file included.