Fetching latest commit…
Cannot retrieve the latest commit at this time.
|Failed to load latest commit information.|
R-IQ-OQ is an R/Sweave 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-IQ-OQ.Rnw 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. 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. There are important notes in the beginning of the R-IQ-OQ.Rnw file that should be completely reviewed regarding how to run the program and related considerations for environmental settings (eg. locale) that can affect the output generated. You will need a local installation of LaTeX in order to process the resultant R-IQ-OQ.tex output file into the final R-IQ-OQ.pdf file. Most Linuxen will either include a LaTeX installation or will provide binaries for easy installation from repos. Windows users will want to look at MikTeX and OSX users at MacTeX, which are provided by third parties. There are a series of CMDFile*.r files which contain R code that are required and are called in a BATCH mode operation from within R-IQ-OQ.Rnw. Be sure that these files are present in the same folder as R-IQ-OQ.Rnw. 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 COPYING file included.